Trial Outcomes & Findings for A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KRP-A218 in Healthy Subjects (NCT NCT04908800)
NCT ID: NCT04908800
Last Updated: 2024-01-08
Results Overview
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after the first dose, or started prior to the first dose and increased in severity after the first dose. Where a subject experienced multiple TEAEs with the same preferred term for the same treatment, this was counted as 1 TEAE for that treatment under the maximum severity recorded.
COMPLETED
PHASE1
99 participants
Screening to follow-up (Approximately 6 weeks)
2024-01-08
Participant Flow
Participant milestones
| Measure |
Part A: Placebo
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted/Fed Male)
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part B: Placebo
Multiple ascending dose study.
Participants received once daily oral doses of placebo from Days 1 to 14. Each dose was administered with approximately 240 mL of room temperature water.
|
Part B: 2 mg KRP-A218
Multiple ascending dose study.
Participants received once daily oral doses of 2 mg KRP-A218 from Days 1 to 14. Each dose was administered with approximately 240 mL of room temperature water.
|
Part B: 4 mg KRP-A218
Multiple ascending dose study.
Participants received once daily oral doses of 4 mg KRP-A218 from Days 1 to 14. Each dose was administered with approximately 240 mL of room temperature water.
|
Part B: 8 mg KRP-A218
Multiple ascending dose study.
Participants received once daily oral doses of 8 mg KRP-A218 from Days 1 to 14. Each dose was administered with approximately 240 mL of room temperature water.
|
Part B: 11 mg KRP-A218
Multiple ascending dose study.
Participants received once daily oral doses of 11 mg KRP-A218 from Days 1 to 14. Each dose was administered with approximately 240 mL of room temperature water.
|
Part C: Drug-drug Interaction Study
Days 1 and 11: single oral dose of 1 mg KRP-A218 (with approximately 240 mL of room temperature water), in the fasted state.
Day 4: 2 × single oral doses of 200 mg itraconazole solution (10 mg/mL) administered with no additional water, approximately 12 hours apart, in the fasted state.
Days 5 to 13: single oral doses of 200 mg itraconazole, solution (10 mg/mL) administered with no additional water, in the fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
5
|
6
|
6
|
6
|
6
|
6
|
8
|
8
|
8
|
8
|
8
|
12
|
|
Overall Study
COMPLETED
|
12
|
5
|
6
|
6
|
6
|
6
|
6
|
8
|
8
|
8
|
7
|
8
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part A: Placebo
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted/Fed Male)
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part B: Placebo
Multiple ascending dose study.
Participants received once daily oral doses of placebo from Days 1 to 14. Each dose was administered with approximately 240 mL of room temperature water.
|
Part B: 2 mg KRP-A218
Multiple ascending dose study.
Participants received once daily oral doses of 2 mg KRP-A218 from Days 1 to 14. Each dose was administered with approximately 240 mL of room temperature water.
|
Part B: 4 mg KRP-A218
Multiple ascending dose study.
Participants received once daily oral doses of 4 mg KRP-A218 from Days 1 to 14. Each dose was administered with approximately 240 mL of room temperature water.
|
Part B: 8 mg KRP-A218
Multiple ascending dose study.
Participants received once daily oral doses of 8 mg KRP-A218 from Days 1 to 14. Each dose was administered with approximately 240 mL of room temperature water.
|
Part B: 11 mg KRP-A218
Multiple ascending dose study.
Participants received once daily oral doses of 11 mg KRP-A218 from Days 1 to 14. Each dose was administered with approximately 240 mL of room temperature water.
|
Part C: Drug-drug Interaction Study
Days 1 and 11: single oral dose of 1 mg KRP-A218 (with approximately 240 mL of room temperature water), in the fasted state.
Day 4: 2 × single oral doses of 200 mg itraconazole solution (10 mg/mL) administered with no additional water, approximately 12 hours apart, in the fasted state.
Days 5 to 13: single oral doses of 200 mg itraconazole, solution (10 mg/mL) administered with no additional water, in the fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KRP-A218 in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Part A: Placebo
n=12 Participants
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
n=5 Participants
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted/Fed Male)
n=6 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
n=6 Participants
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
n=6 Participants
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
n=6 Participants
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
n=6 Participants
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part B: Placebo
n=8 Participants
Multiple ascending dose study.
Participants received once daily oral doses of placebo from Days 1 to 14. Each dose was administered with approximately 240 mL of room temperature water.
|
Part B: 2 mg KRP-A218
n=8 Participants
Multiple ascending dose study.
Participants received once daily oral doses of 2 mg KRP-A218 from Days 1 to 14. Each dose was administered with approximately 240 mL of room temperature water.
|
Part B: 4 mg KRP-A218
n=8 Participants
Multiple ascending dose study.
Participants received once daily oral doses of 4 mg KRP-A218 from Days 1 to 14. Each dose was administered with approximately 240 mL of room temperature water.
|
Part B: 8 mg KRP-A218
n=8 Participants
Multiple ascending dose study.
Participants received once daily oral doses of 8 mg KRP-A218 from Days 1 to 14. Each dose was administered with approximately 240 mL of room temperature water.
|
Part B: 11 mg KRP-A218
n=8 Participants
Multiple ascending dose study.
Participants received once daily oral doses of 11 mg KRP-A218 from Days 1 to 14. Each dose was administered with approximately 240 mL of room temperature water.
|
Part C: Drug-drug Interaction Study
n=12 Participants
Days 1 and 11: single oral dose of 1 mg KRP-A218 (with approximately 240 mL of room temperature water), in the fasted state.
Day 4: 2 × single oral doses of 200 mg itraconazole solution (10 mg/mL) administered with no additional water, approximately 12 hours apart, in the fasted state.
Days 5 to 13: single oral doses of 200 mg itraconazole, solution (10 mg/mL) administered with no additional water, in the fasted state.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
31.5 years
STANDARD_DEVIATION 6.43 • n=5 Participants
|
27.4 years
STANDARD_DEVIATION 2.41 • n=7 Participants
|
35.0 years
STANDARD_DEVIATION 12.68 • n=5 Participants
|
36.3 years
STANDARD_DEVIATION 11.91 • n=4 Participants
|
38.8 years
STANDARD_DEVIATION 9.39 • n=21 Participants
|
31.0 years
STANDARD_DEVIATION 6.13 • n=8 Participants
|
30.8 years
STANDARD_DEVIATION 4.71 • n=8 Participants
|
36.5 years
STANDARD_DEVIATION 13.78 • n=24 Participants
|
32.3 years
STANDARD_DEVIATION 9.77 • n=42 Participants
|
38.4 years
STANDARD_DEVIATION 10.77 • n=42 Participants
|
37.5 years
STANDARD_DEVIATION 9.96 • n=42 Participants
|
31.9 years
STANDARD_DEVIATION 9.48 • n=42 Participants
|
36.4 years
STANDARD_DEVIATION 11.01 • n=36 Participants
|
34.3 years
STANDARD_DEVIATION 9.69 • n=36 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
8 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
12 Participants
n=36 Participants
|
91 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
12 Participants
n=36 Participants
|
99 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
8 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
12 Participants
n=36 Participants
|
85 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
|
Height
|
174.42 centimetres
STANDARD_DEVIATION 9.549 • n=5 Participants
|
180.80 centimetres
STANDARD_DEVIATION 4.970 • n=7 Participants
|
170.00 centimetres
STANDARD_DEVIATION 3.347 • n=5 Participants
|
165.33 centimetres
STANDARD_DEVIATION 4.082 • n=4 Participants
|
180.33 centimetres
STANDARD_DEVIATION 7.394 • n=21 Participants
|
180.33 centimetres
STANDARD_DEVIATION 2.503 • n=8 Participants
|
181.00 centimetres
STANDARD_DEVIATION 7.239 • n=8 Participants
|
174.13 centimetres
STANDARD_DEVIATION 3.796 • n=24 Participants
|
180.63 centimetres
STANDARD_DEVIATION 5.449 • n=42 Participants
|
182.13 centimetres
STANDARD_DEVIATION 4.121 • n=42 Participants
|
174.63 centimetres
STANDARD_DEVIATION 8.634 • n=42 Participants
|
175.63 centimetres
STANDARD_DEVIATION 5.975 • n=42 Participants
|
180.25 centimetres
STANDARD_DEVIATION 7.275 • n=36 Participants
|
176.96 centimetres
STANDARD_DEVIATION 7.593 • n=36 Participants
|
|
Body Weight
|
74.44 kilograms
STANDARD_DEVIATION 10.453 • n=5 Participants
|
82.08 kilograms
STANDARD_DEVIATION 12.815 • n=7 Participants
|
72.50 kilograms
STANDARD_DEVIATION 9.134 • n=5 Participants
|
65.23 kilograms
STANDARD_DEVIATION 8.138 • n=4 Participants
|
85.80 kilograms
STANDARD_DEVIATION 8.734 • n=21 Participants
|
83.20 kilograms
STANDARD_DEVIATION 7.654 • n=8 Participants
|
82.37 kilograms
STANDARD_DEVIATION 11.934 • n=8 Participants
|
74.34 kilograms
STANDARD_DEVIATION 7.558 • n=24 Participants
|
82.01 kilograms
STANDARD_DEVIATION 10.405 • n=42 Participants
|
83.29 kilograms
STANDARD_DEVIATION 8.061 • n=42 Participants
|
74.75 kilograms
STANDARD_DEVIATION 14.155 • n=42 Participants
|
81.33 kilograms
STANDARD_DEVIATION 11.106 • n=42 Participants
|
79.20 kilograms
STANDARD_DEVIATION 7.228 • n=36 Participants
|
78.33 kilograms
STANDARD_DEVIATION 10.653 • n=36 Participants
|
|
Body Mass Index
|
24.43 kilograms/metres squared
STANDARD_DEVIATION 2.411 • n=5 Participants
|
25.00 kilograms/metres squared
STANDARD_DEVIATION 2.769 • n=7 Participants
|
25.12 kilograms/metres squared
STANDARD_DEVIATION 3.589 • n=5 Participants
|
23.90 kilograms/metres squared
STANDARD_DEVIATION 3.239 • n=4 Participants
|
26.35 kilograms/metres squared
STANDARD_DEVIATION 1.866 • n=21 Participants
|
25.55 kilograms/metres squared
STANDARD_DEVIATION 1.981 • n=8 Participants
|
25.03 kilograms/metres squared
STANDARD_DEVIATION 2.166 • n=8 Participants
|
24.48 kilograms/metres squared
STANDARD_DEVIATION 1.855 • n=24 Participants
|
25.06 kilograms/metres squared
STANDARD_DEVIATION 2.304 • n=42 Participants
|
25.15 kilograms/metres squared
STANDARD_DEVIATION 2.718 • n=42 Participants
|
24.36 kilograms/metres squared
STANDARD_DEVIATION 3.225 • n=42 Participants
|
26.39 kilograms/metres squared
STANDARD_DEVIATION 3.321 • n=42 Participants
|
24.38 kilograms/metres squared
STANDARD_DEVIATION 1.847 • n=36 Participants
|
24.95 kilograms/metres squared
STANDARD_DEVIATION 2.519 • n=36 Participants
|
PRIMARY outcome
Timeframe: Screening to follow-up (Approximately 6 weeks)Population: Safety population
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after the first dose, or started prior to the first dose and increased in severity after the first dose. Where a subject experienced multiple TEAEs with the same preferred term for the same treatment, this was counted as 1 TEAE for that treatment under the maximum severity recorded.
Outcome measures
| Measure |
Part A: Placebo
n=12 Participants
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
n=5 Participants
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)
n=6 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)
n=6 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
n=6 Participants
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
n=6 Participants
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
n=6 Participants
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
n=6 Participants
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Adverse Events
Overall TEAEs
|
4 participants
|
3 participants
|
4 participants
|
3 participants
|
2 participants
|
2 participants
|
3 participants
|
2 participants
|
|
Part A: Number of Participants With Adverse Events
Serious TEAEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Part A: Number of Participants With Adverse Events
TEAEs Leading to Discontinuation
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Part A: Number of Participants With Adverse Events
TEAEs Leading to Death
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Screening to follow-up (Approximately 8 weeks)Population: Safety population
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after the first dose, or started prior to the first dose and increased in severity after the first dose. Where a subject experienced multiple TEAEs with the same preferred term for the same treatment, this was counted as 1 TEAE for that treatment under the maximum severity recorded.
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
n=8 Participants
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)
n=8 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)
n=8 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
n=8 Participants
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With Adverse Events
Overall TEAEs
|
6 participants
|
3 participants
|
7 participants
|
5 participants
|
5 participants
|
—
|
—
|
—
|
|
Part B: Number of Participants With Adverse Events
Serious TEAEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
|
Part B: Number of Participants With Adverse Events
TEAEs leading to discontinuation
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
—
|
—
|
—
|
|
Part B: Number of Participants With Adverse Events
TEAEs leading to death
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 to 11Population: Pharmacokinetic Population)
The area under concentration-time curve from time 0 extrapolated to infinity (AUC0-infinity) following Oral Dose Administration of KRP-A218 Alone and in Combination with Itraconazole
Outcome measures
| Measure |
Part A: Placebo
n=12 Participants
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
n=12 Participants
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: Area Under Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-infinity)
|
191 ng*h/mL
Geometric Coefficient of Variation 23.9
|
360 ng*h/mL
Geometric Coefficient of Variation 25.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 to 11Population: Pharmacokinetic population
The area under concentration-time curve from time 0 extrapolated to last quantifiable concentration following Oral Dose Administration of KRP-A218 Alone and in Combination with Itraconazole
Outcome measures
| Measure |
Part A: Placebo
n=12 Participants
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
n=12 Participants
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: Area Under Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast)
|
182 ng*h/mL
Geometric Coefficient of Variation 22.8
|
306 ng*h/mL
Geometric Coefficient of Variation 23.5
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 to 11The maximum observed concentration following Oral Dose Administration of KRP-A218 Alone and in Combination with Itraconazole
Outcome measures
| Measure |
Part A: Placebo
n=12 Participants
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
n=12 Participants
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: Maximum Observed Concentration (Cmax)
|
10.7 ng/mL
Geometric Coefficient of Variation 20.3
|
12.2 ng/mL
Geometric Coefficient of Variation 20.9
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 to 11Population: Pharmacokinetic population
The time of the maximum observed concentration following Oral Dose Administration of KRP-A218 Alone and in Combination with Itraconazole
Outcome measures
| Measure |
Part A: Placebo
n=12 Participants
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
n=12 Participants
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: Time of the Maximum Observed Concentration (Tmax)
|
3.00 hours
Interval 2.0 to 4.0
|
2.00 hours
Interval 1.5 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 to 11Population: Pharmacokinetic population
The apparent terminal elimination half-life following Oral Dose Administration of KRP-A218 Alone and in Combination with Itraconazole
Outcome measures
| Measure |
Part A: Placebo
n=12 Participants
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
n=12 Participants
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: Apparent Terminal Elimination Half-life (t1/2)
|
15.9 hours
Geometric Coefficient of Variation 10.1
|
26.5 hours
Geometric Coefficient of Variation 15.5
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 to 11Population: Pharmacokinetic population
The apparent total clearance following Oral Dose Administration of KRP-A218 Alone and in Combination with Itraconazole
Outcome measures
| Measure |
Part A: Placebo
n=12 Participants
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
n=12 Participants
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: Apparent Total Clearance (CL/F)
|
5.24 Liter Per Hour
Geometric Coefficient of Variation 23.9
|
2.78 Liter Per Hour
Geometric Coefficient of Variation 25.0
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Days 1 to 11Population: Pharmacokinetic population
The apparent volume of distribution during the terminal phase following Oral Dose Administration of KRP-A218 Alone and in Combination with Itraconazole
Outcome measures
| Measure |
Part A: Placebo
n=12 Participants
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
n=12 Participants
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: Apparent Volume of Distribution During the Terminal Phase (Vz/F)
|
120 liters
Geometric Coefficient of Variation 17.6
|
106 liters
Geometric Coefficient of Variation 23.8
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Pharmacokinetic population
Area under concentration-time curve from time 0 extrapolated to infinity following single oral dose of KRP-A218
Outcome measures
| Measure |
Part A: Placebo
n=5 Participants
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
n=6 Participants
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)
n=6 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)
n=6 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
n=6 Participants
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
n=6 Participants
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
n=6 Participants
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Area Under Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-infinity)
|
210 ng*h/mL
Geometric Coefficient of Variation 18.8
|
600 ng*h/mL
Geometric Coefficient of Variation 43.2
|
607 ng*h/mL
Geometric Coefficient of Variation 36.9
|
634 ng*h/mL
Geometric Coefficient of Variation 18.0
|
1230 ng*h/mL
Geometric Coefficient of Variation 28.3
|
2600 ng*h/mL
Geometric Coefficient of Variation 23.9
|
3810 ng*h/mL
Geometric Coefficient of Variation 17.9
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Pharmacokinetic population
Area under curve from time 0 to the time of the last quantifiable concentration following single oral dose of KRP-A218
Outcome measures
| Measure |
Part A: Placebo
n=5 Participants
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
n=6 Participants
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)
n=6 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)
n=6 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
n=6 Participants
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
n=6 Participants
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
n=6 Participants
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Area Under Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast)
|
198 ng*h/mL
Geometric Coefficient of Variation 18.4
|
575 ng*h/mL
Geometric Coefficient of Variation 40.4
|
578 ng*h/mL
Geometric Coefficient of Variation 33.3
|
600 ng*h/mL
Geometric Coefficient of Variation 18.4
|
1160 ng*h/mL
Geometric Coefficient of Variation 28.4
|
2490 ng*h/mL
Geometric Coefficient of Variation 24.0
|
3680 ng*h/mL
Geometric Coefficient of Variation 17.5
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Pharmacokinetic population
Maximum observed concentration following single oral dose of KRP-A218
Outcome measures
| Measure |
Part A: Placebo
n=5 Participants
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
n=6 Participants
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)
n=6 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)
n=6 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
n=6 Participants
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
n=6 Participants
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
n=6 Participants
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Maximum Observed Concentration (Cmax)
|
11.9 ng/mL
Geometric Coefficient of Variation 30.3
|
31.6 ng/mL
Geometric Coefficient of Variation 27.7
|
30.0 ng/mL
Geometric Coefficient of Variation 16.6
|
38.8 ng/mL
Geometric Coefficient of Variation 14.6
|
60.3 ng/mL
Geometric Coefficient of Variation 26.5
|
146 ng/mL
Geometric Coefficient of Variation 16.5
|
236 ng/mL
Geometric Coefficient of Variation 15.9
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Pharmacokinetic population
Time of the maximum observed concentration following single oral dose of KRP-A218
Outcome measures
| Measure |
Part A: Placebo
n=5 Participants
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
n=6 Participants
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)
n=6 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)
n=6 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
n=6 Participants
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
n=6 Participants
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
n=6 Participants
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Time of the Maximum Observed Concentration (Tmax)
|
3.00 hours
Interval 2.0 to 4.0
|
4.00 hours
Interval 2.02 to 4.0
|
3.50 hours
Interval 1.5 to 8.02
|
4.00 hours
Interval 3.0 to 4.02
|
3.50 hours
Interval 1.5 to 4.0
|
3.00 hours
Interval 2.0 to 4.0
|
3.00 hours
Interval 2.0 to 3.02
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Pharmacokinetic population
Apparent terminal elimination half-life following single oral dose of KRP-A218
Outcome measures
| Measure |
Part A: Placebo
n=5 Participants
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
n=6 Participants
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)
n=6 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)
n=6 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
n=6 Participants
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
n=6 Participants
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
n=6 Participants
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Apparent Terminal Elimination Half-life (t1/2)
|
18.5 hours
Geometric Coefficient of Variation 12.0
|
15.0 hours
Geometric Coefficient of Variation 27.4
|
15.7 hours
Geometric Coefficient of Variation 22.9
|
18.1 hours
Geometric Coefficient of Variation 29.3
|
17.6 hours
Geometric Coefficient of Variation 11.1
|
16.4 hours
Geometric Coefficient of Variation 12.1
|
14.8 hours
Geometric Coefficient of Variation 14.0
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Pharmacokinetic population
Apparent total clearance following single oral dose of KRP-A218
Outcome measures
| Measure |
Part A: Placebo
n=5 Participants
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
n=6 Participants
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)
n=6 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)
n=6 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
n=6 Participants
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
n=6 Participants
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
n=6 Participants
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Apparent Total Clearance (CL/F)
|
4.76 liters per hour
Geometric Coefficient of Variation 18.8
|
5.00 liters per hour
Geometric Coefficient of Variation 43.2
|
4.94 liters per hour
Geometric Coefficient of Variation 36.9
|
4.74 liters per hour
Geometric Coefficient of Variation 18.0
|
4.89 liters per hour
Geometric Coefficient of Variation 28.3
|
4.61 liters per hour
Geometric Coefficient of Variation 23.9
|
5.52 liters per hour
Geometric Coefficient of Variation 17.9
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Pharmacokinetic population
Apparent volume of distribution during the terminal phase following single oral dose of KRP-A218
Outcome measures
| Measure |
Part A: Placebo
n=5 Participants
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
n=6 Participants
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)
n=6 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)
n=6 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
n=6 Participants
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
n=6 Participants
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
n=6 Participants
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Part A: Apparent Volume of Distribution During the Terminal Phase (Vz/F)
|
127 liters
Geometric Coefficient of Variation 16.4
|
108 liters
Geometric Coefficient of Variation 26.9
|
112 liters
Geometric Coefficient of Variation 14.2
|
124 liters
Geometric Coefficient of Variation 37.4
|
124 liters
Geometric Coefficient of Variation 31.5
|
109 liters
Geometric Coefficient of Variation 30.3
|
117 liters
Geometric Coefficient of Variation 20.2
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 14Population: Pharmacokinetic population
Assessment of the area under the concentration-time curve over a dosing interval (AUC0-τ)
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
n=8 Participants
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)
n=8 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)
n=8 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Area Under the Concentration-time Curve Over a Dosing Interval (AUC0-τ)
Day 1
|
254 ng*h/mL
Geometric Coefficient of Variation 13.7
|
560 ng*h/mL
Geometric Coefficient of Variation 18.7
|
1170 ng*h/mL
Geometric Coefficient of Variation 38.8
|
1760 ng*h/mL
Geometric Coefficient of Variation 27.5
|
—
|
—
|
—
|
—
|
|
Part B: Area Under the Concentration-time Curve Over a Dosing Interval (AUC0-τ)
Day 14
|
395 ng*h/mL
Geometric Coefficient of Variation 24.1
|
813 ng*h/mL
Geometric Coefficient of Variation 24.5
|
1630 ng*h/mL
Geometric Coefficient of Variation 21.9
|
2760 ng*h/mL
Geometric Coefficient of Variation 35.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Pharmacokinetic population
Assessment of the area under concentration-time curve from time 0 extrapolated to infinity (AUC0-infinity)
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
n=8 Participants
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)
n=8 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)
n=8 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Area Under Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-infinity)
|
367 ng*h/mL
Geometric Coefficient of Variation 18.5
|
800 ng*h/mL
Geometric Coefficient of Variation 24.2
|
1590 ng*h/mL
Geometric Coefficient of Variation 42.5
|
2480 ng*h/mL
Geometric Coefficient of Variation 34.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 14Population: Pharmacokinetic population
Assessment of the area under curve from time 0 to the time of the last quantifiable concentration (AUC0-tlast)
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
n=8 Participants
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)
n=8 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)
n=8 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Area Under Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast)
Day 1
|
253 ng*h/mL
Geometric Coefficient of Variation 13.7
|
558 ng*h/mL
Geometric Coefficient of Variation 18.7
|
1170 ng*h/mL
Geometric Coefficient of Variation 38.8
|
1750 ng*h/mL
Geometric Coefficient of Variation 27.5
|
—
|
—
|
—
|
—
|
|
Part B: Area Under Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast)
Day 14
|
575 ng*h/mL
Geometric Coefficient of Variation 28.2
|
1170 ng*h/mL
Geometric Coefficient of Variation 29.1
|
2370 ng*h/mL
Geometric Coefficient of Variation 24.7
|
4050 ng*h/mL
Geometric Coefficient of Variation 43.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 14Population: Pharmacokinetic population
Assessment of the maximum observed concentration (Cmax)
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
n=8 Participants
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)
n=8 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)
n=8 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Maximum Observed Concentration (Cmax)
Day 1
|
20.0 ng/mL
Geometric Coefficient of Variation 14.2
|
44.0 ng/mL
Geometric Coefficient of Variation 14.5
|
99.0 ng/mL
Geometric Coefficient of Variation 32.4
|
137 ng/mL
Geometric Coefficient of Variation 24.5
|
—
|
—
|
—
|
—
|
|
Part B: Maximum Observed Concentration (Cmax)
Day 14
|
29.9 ng/mL
Geometric Coefficient of Variation 20.8
|
60.9 ng/mL
Geometric Coefficient of Variation 23.5
|
121 ng/mL
Geometric Coefficient of Variation 17.7
|
204 ng/mL
Geometric Coefficient of Variation 28.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 14Population: Pharmacokinetic population
Assessment of the minimum observed concentration (Cmin)
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
n=8 Participants
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)
n=7 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)
n=8 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Minimum Observed Concentration (Cmin)
|
9.09 ng/mL
Geometric Coefficient of Variation 33.1
|
18.5 ng/mL
Geometric Coefficient of Variation 35.3
|
33.0 ng/mL
Geometric Coefficient of Variation 27.9
|
59.6 ng/mL
Geometric Coefficient of Variation 45.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 14Population: Pharmacokinetic population
Assessment of the time of the maximum observed concentration (Tmax)
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
n=8 Participants
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)
n=8 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)
n=8 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Time of the Maximum Observed Concentration (Tmax)
Day 1
|
3.00 hours
Interval 2.0 to 4.0
|
3.00 hours
Interval 2.0 to 4.0
|
3.00 hours
Interval 2.0 to 4.0
|
3.50 hours
Interval 2.0 to 6.0
|
—
|
—
|
—
|
—
|
|
Part B: Time of the Maximum Observed Concentration (Tmax)
Day 14
|
3.00 hours
Interval 1.5 to 4.07
|
3.50 hours
Interval 2.0 to 4.0
|
4.00 hours
Interval 3.0 to 4.02
|
3.00 hours
Interval 1.5 to 3.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 14Population: Pharmacokinetic population
Assessment of the apparent terminal elimination half-life (t1/2)
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
n=8 Participants
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)
n=8 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)
n=8 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Apparent Terminal Elimination Half-life (t1/2)
Day 1
|
13.0 hours
Geometric Coefficient of Variation 18.8
|
12.5 hours
Geometric Coefficient of Variation 15.8
|
11.7 hours
Geometric Coefficient of Variation 12.4
|
12.6 hours
Geometric Coefficient of Variation 16.9
|
—
|
—
|
—
|
—
|
|
Part B: Apparent Terminal Elimination Half-life (t1/2)
Day 14
|
18.8 hours
Geometric Coefficient of Variation 39.5
|
16.2 hours
Geometric Coefficient of Variation 22.1
|
17.6 hours
Geometric Coefficient of Variation 21.0
|
17.2 hours
Geometric Coefficient of Variation 20.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 14Population: Pharmacokinetic population
Assessment of the apparent total clearance (CL/F)
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
n=8 Participants
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)
n=8 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)
n=8 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Apparent Total Clearance (CL/F)
Day 1
|
5.45 liters per hour
Geometric Coefficient of Variation 18.5
|
5.00 liters per hour
Geometric Coefficient of Variation 24.2
|
5.03 liters per hour
Geometric Coefficient of Variation 42.5
|
4.44 liters per hour
Geometric Coefficient of Variation 34.2
|
—
|
—
|
—
|
—
|
|
Part B: Apparent Total Clearance (CL/F)
Day 14
|
5.06 liters per hour
Geometric Coefficient of Variation 24.1
|
4.92 liters per hour
Geometric Coefficient of Variation 24.5
|
4.90 liters per hour
Geometric Coefficient of Variation 21.9
|
3.99 liters per hour
Geometric Coefficient of Variation 35.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 1 and 14Population: Pharmacokinetic population
Assessment of the apparent volume of distribution during the terminal phase (Vz/F)
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
n=8 Participants
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)
n=8 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)
n=8 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Apparent Volume of Distribution During the Terminal Phase (Vz/F)
Day 1
|
102 liters
Geometric Coefficient of Variation 13.2
|
89.9 liters
Geometric Coefficient of Variation 13.8
|
84.6 liters
Geometric Coefficient of Variation 35.4
|
80.7 liters
Geometric Coefficient of Variation 24.0
|
—
|
—
|
—
|
—
|
|
Part B: Apparent Volume of Distribution During the Terminal Phase (Vz/F)
Day 14
|
137 liters
Geometric Coefficient of Variation 52.1
|
115 liters
Geometric Coefficient of Variation 23.1
|
124 liters
Geometric Coefficient of Variation 34.1
|
99.0 liters
Geometric Coefficient of Variation 23.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 14Population: Pharmacokinetic population
Observed accumulation ratio based on area under the concentration-time curve over a dosing interval (ARAUC0-T) in Part B
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
n=8 Participants
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)
n=7 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)
n=8 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Observed Accumulation Ratio Based on Area Under the Concentration-Time Curve Over a Dosing Interval (ARAUC0-T)
|
1.56 ratio
Geometric Coefficient of Variation 13.6
|
1.45 ratio
Geometric Coefficient of Variation 14.2
|
1.41 ratio
Geometric Coefficient of Variation 19.1
|
1.57 ratio
Geometric Coefficient of Variation 14.7
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 14Population: Pharmacokinetic population
Observed accumulation ratio based on maximum observed concentration during the dosing interval (ARCmax) in Part B
Outcome measures
| Measure |
Part A: Placebo
n=8 Participants
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
n=8 Participants
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)
n=7 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)
n=8 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Part B: Observed Accumulation Ratio Based on Maximum Observed Concentration During the Dosing Interval (ARCmax)
|
1.49 ratio
Geometric Coefficient of Variation 14.0
|
1.38 ratio
Geometric Coefficient of Variation 11.8
|
1.21 ratio
Geometric Coefficient of Variation 17.0
|
1.49 ratio
Geometric Coefficient of Variation 9.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening to follow-up (Approximately 7 weeks)Population: Safety population
A treatment-emergent adverse event (TEAE) was defined as an adverse event that started during or after the first dose, or started prior to the first dose and increased in severity after the first dose. Where a subject experienced multiple TEAEs with the same preferred term for the same treatment, this was counted as 1 TEAE for that treatment under the maximum severity recorded.
Outcome measures
| Measure |
Part A: Placebo
n=12 Participants
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
n=12 Participants
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)
n=12 Participants
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
|---|---|---|---|---|---|---|---|---|
|
Part C: Number of Participants With Adverse Events
Overall TEAEs
|
5 participants
|
3 participants
|
6 participants
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Adverse Events
Serious TEAEs
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Adverse Events
TEAEs leading to discontinuation
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
|
Part C: Number of Participants With Adverse Events
TEAEs leading to death
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part A: Placebo
Part A: 1 mg KRP-A218 (Fasted Male)
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)
Part A: 3 mg KRP-A218 (Fasted Female)
Part A: 6 mg KRP-A218 (Fasted Male)
Part A: 12 mg KRP-A218 (Fasted Male)
Part A: 21 mg KRP-A218 (Fasted Male)
Part B: Placebo
Part B: 2 mg KRP-A218
Part B: 4 mg KRP-A218
Part B: 8 mg KRP-A218
Part B: 11 mg KRP-A218
Part C: Drug-drug Interaction Study: 1 mg KRP-A218 Alone
Part C: Drug-drug Interaction Study: 200 mg Itraconazole Alone
Part C: Drug-drug Interaction Study: 1 mg KRP-A218 + 200 mg Itraconazole
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A: Placebo
n=12 participants at risk
Single ascending dose study.
Participants received a single order dose of placebo with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
For those randomized to the Fasted/Fed group, on Day 1, Treatment Period 2, male participants also received a single order dose of placebo 30 minutes after starting a high-fat breakfast.
|
Part A: 1 mg KRP-A218 (Fasted Male)
n=5 participants at risk
Single ascending dose study.
Participants received a single order dose of 1 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)
n=6 participants at risk
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)
n=6 participants at risk
Single ascending dose study.
On Day 1, Treatment Period 1, male participants received a single order dose of 3 mg KRP-A218 after an overnight fast of at least 10 hours.
On Day 1, Treatment Period 2, male participants received a single order dose of 3 mg KRP-A218 30 minutes after starting a high-fat breakfast.
|
Part A: 3 mg KRP-A218 (Fasted Female)
n=6 participants at risk
Single ascending dose study.
Female participants received a single order dose of 3 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 6 mg KRP-A218 (Fasted Male)
n=6 participants at risk
Single ascending dose study.
Male participants received a single order dose of 6 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 12 mg KRP-A218 (Fasted Male)
n=6 participants at risk
Single ascending dose study.
Male participants received a single order dose of 12 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part A: 21 mg KRP-A218 (Fasted Male)
n=6 participants at risk
Single ascending dose study.
Male participants received a single order dose of 21 mg KRP-A218 with approximately 240 mL of room temperature water after an overnight fast of at least 10 hours.
|
Part B: Placebo
n=8 participants at risk
Multiple ascending dose study.
Participants received once daily oral doses of placebo from Days 1 to 14. Each dose was administered with approximately 240 mL of room temperature water.
|
Part B: 2 mg KRP-A218
n=8 participants at risk
Multiple ascending dose study.
Participants received once daily oral doses of 2 mg KRP-A218 from Days 1 to 14. Each dose was administered with approximately 240 mL of room temperature water.
|
Part B: 4 mg KRP-A218
n=8 participants at risk
Multiple ascending dose study.
Participants received once daily oral doses of 4 mg KRP-A218 from Days 1 to 14. Each dose was administered with approximately 240 mL of room temperature water.
|
Part B: 8 mg KRP-A218
n=8 participants at risk
Multiple ascending dose study.
Participants received once daily oral doses of 8 mg KRP-A218 from Days 1 to 14. Each dose was administered with approximately 240 mL of room temperature water.
|
Part B: 11 mg KRP-A218
n=8 participants at risk
Multiple ascending dose study.
Participants received once daily oral doses of 11 mg KRP-A218 from Days 1 to 14. Each dose was administered with approximately 240 mL of room temperature water.
|
Part C: Drug-drug Interaction Study: 1 mg KRP-A218 Alone
n=12 participants at risk
Days 1 and 11: single oral dose of 1 mg KRP-A218 (with approximately 240 mL of room temperature water), in the fasted state.
|
Part C: Drug-drug Interaction Study: 200 mg Itraconazole Alone
n=12 participants at risk
Day 4: 2 × single oral doses of 200 mg itraconazole solution (10 mg/mL) administered with no additional water, approximately 12 hours apart, in the fasted state.
|
Part C: Drug-drug Interaction Study: 1 mg KRP-A218 + 200 mg Itraconazole
n=12 participants at risk
Days 5 to 13: single oral doses of 200 mg itraconazole, solution (10 mg/mL) administered with no additional water, in the fasted state.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
20.0%
1/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
33.3%
2/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
33.3%
2/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
16.7%
1/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
16.7%
1/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
33.3%
2/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
33.3%
2/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
50.0%
4/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
25.0%
2/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
75.0%
6/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
37.5%
3/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
50.0%
4/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
25.0%
3/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
25.0%
3/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
33.3%
4/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
16.7%
1/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
16.7%
1/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Gastrointestinal disorders
Haematochezia
|
8.3%
1/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
16.7%
1/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
16.7%
1/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
25.0%
2/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Gastrointestinal disorders
Dyschezia
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
16.7%
1/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Gastrointestinal disorders
Flatulence
|
8.3%
1/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
16.7%
1/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
12.5%
1/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
12.5%
1/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
16.7%
1/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
12.5%
1/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
12.5%
1/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
12.5%
1/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
25.0%
2/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Gastrointestinal disorders
Faeces hard
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
12.5%
1/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
12.5%
1/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
12.5%
1/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
8.3%
1/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Nervous system disorders
Headache
|
16.7%
2/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
20.0%
1/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
16.7%
1/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
12.5%
1/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
25.0%
2/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
25.0%
2/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
8.3%
1/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
8.3%
1/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Nervous system disorders
Somnolence
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
16.7%
1/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
16.7%
1/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
12.5%
1/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Nervous system disorders
Dizziness
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
16.7%
1/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
12.5%
1/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Nervous system disorders
Presyncope
|
8.3%
1/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
1/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
20.0%
1/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
16.7%
1/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
8.3%
1/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
16.7%
1/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
12.5%
1/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
12.5%
1/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
12.5%
1/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
General disorders
Catheter site bruise
|
8.3%
1/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
16.7%
1/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
12.5%
1/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.3%
1/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
20.0%
1/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Renal and urinary disorders
Pollakiuria
|
8.3%
1/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
12.5%
1/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
16.7%
1/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
16.7%
1/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Vascular disorders
Hot flush
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
16.7%
1/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
12.5%
1/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
12.5%
1/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
8.3%
1/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
12.5%
1/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
8.3%
1/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
General disorders
Catheter site pain
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
12.5%
1/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
General disorders
Catheter site swelling
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
12.5%
1/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
General disorders
Feeling cold
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
12.5%
1/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
General disorders
Hunger
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
12.5%
1/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Investigations
Bleeding time prolonged
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
12.5%
1/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Investigations
Faecal volume decreased
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
12.5%
1/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Infections and infestations
Oral herpes
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
25.0%
2/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
12.5%
1/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
12.5%
1/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
12.5%
1/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
8.3%
1/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Psychiatric disorders
Irritability
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
12.5%
1/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
12.5%
1/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
8.3%
1/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
General disorders
Feeling hot
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
8.3%
1/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
General disorders
Malaise
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
8.3%
1/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
8.3%
1/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/5 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/6 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/8 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
8.3%
1/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
0.00%
0/12 • Over 4 months from screening (Days -28 to -2), throughout the treatment period (Days -1 to 72), and at follow-up (7 to 10 days postdose) if applicable.
Fed/fasted group in Part A: * treatment-emergent adverse events (TEAEs) on/after Period 1, Day (D) 1 dose and prior to Period 2, D1 dose assigned to 3 mg KRP-A218 (Fasted Male) * TEAEs on/after Period 2, D1 dose assigned to 3 mg KRP-A218 (Fed Male) Part C: * TEAEs on/after D1 dose and prior to D4 dosing assigned to 1 mg KRP-A218 * TEAEs on/after D4 dose and prior to D11 dosing assigned to 200 mg Itraconazole * TEAEs on/after D11 dose assigned to 1 mg KRP-A218 and 200 mg Itraconazole
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Each party agrees that all confidential information of the disclosing part is and shall we the sole property of the disclosing party. Without prejudice to any Labcorp Property, all test information, results, data and records developed by Labcorp specifically as a result of performing the study and related to the test materials or sponsor information shall be the confidential information of the sponsor.
- Publication restrictions are in place
Restriction type: OTHER