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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

99 participants

Primary outcome timeframe

Screening to follow-up (Approximately 6 weeks)

Results posted on

2024-01-08

Participant Flow

Participant milestones

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

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

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

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

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 11

Population: 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

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 11

Population: 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

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 11

The maximum observed concentration following Oral Dose Administration of KRP-A218 Alone and in Combination with Itraconazole

Outcome measures

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 11

Population: Pharmacokinetic population

The time of the maximum observed concentration following Oral Dose Administration of KRP-A218 Alone and in Combination with Itraconazole

Outcome measures

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 11

Population: Pharmacokinetic population

The apparent terminal elimination half-life following Oral Dose Administration of KRP-A218 Alone and in Combination with Itraconazole

Outcome measures

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 11

Population: Pharmacokinetic population

The apparent total clearance following Oral Dose Administration of KRP-A218 Alone and in Combination with Itraconazole

Outcome measures

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 11

Population: 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

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 1

Population: Pharmacokinetic population

Area under concentration-time curve from time 0 extrapolated to infinity following single oral dose of KRP-A218

Outcome measures

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 1

Population: 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

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 1

Population: Pharmacokinetic population

Maximum observed concentration following single oral dose of KRP-A218

Outcome measures

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 1

Population: Pharmacokinetic population

Time of the maximum observed concentration following single oral dose of KRP-A218

Outcome measures

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 1

Population: Pharmacokinetic population

Apparent terminal elimination half-life following single oral dose of KRP-A218

Outcome measures

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 1

Population: Pharmacokinetic population

Apparent total clearance following single oral dose of KRP-A218

Outcome measures

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 1

Population: Pharmacokinetic population

Apparent volume of distribution during the terminal phase following single oral dose of KRP-A218

Outcome measures

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 14

Population: Pharmacokinetic population

Assessment of the area under the concentration-time curve over a dosing interval (AUC0-τ)

Outcome measures

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 1

Population: Pharmacokinetic population

Assessment of the area under concentration-time curve from time 0 extrapolated to infinity (AUC0-infinity)

Outcome measures

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 14

Population: Pharmacokinetic population

Assessment of the area under curve from time 0 to the time of the last quantifiable concentration (AUC0-tlast)

Outcome measures

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 14

Population: Pharmacokinetic population

Assessment of the maximum observed concentration (Cmax)

Outcome measures

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 14

Population: Pharmacokinetic population

Assessment of the minimum observed concentration (Cmin)

Outcome measures

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 14

Population: Pharmacokinetic population

Assessment of the time of the maximum observed concentration (Tmax)

Outcome measures

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 14

Population: Pharmacokinetic population

Assessment of the apparent terminal elimination half-life (t1/2)

Outcome measures

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 14

Population: Pharmacokinetic population

Assessment of the apparent total clearance (CL/F)

Outcome measures

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 14

Population: Pharmacokinetic population

Assessment of the apparent volume of distribution during the terminal phase (Vz/F)

Outcome measures

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 14

Population: Pharmacokinetic population

Observed accumulation ratio based on area under the concentration-time curve over a dosing interval (ARAUC0-T) in Part B

Outcome measures

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 14

Population: Pharmacokinetic population

Observed accumulation ratio based on maximum observed concentration during the dosing interval (ARCmax) in Part B

Outcome measures

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

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

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Part A: 1 mg KRP-A218 (Fasted Male)

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Part A: 3 mg KRP-A218 (Fasted Male: Treatment Period 1)

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Part A: 3 mg KRP-A218 (Fed Male: Treatment Period 2)

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Part A: 3 mg KRP-A218 (Fasted Female)

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Part A: 6 mg KRP-A218 (Fasted Male)

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Part A: 12 mg KRP-A218 (Fasted Male)

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Part A: 21 mg KRP-A218 (Fasted Male)

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Part B: Placebo

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Part B: 2 mg KRP-A218

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Part B: 4 mg KRP-A218

Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths

Part B: 8 mg KRP-A218

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Part B: 11 mg KRP-A218

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Part C: Drug-drug Interaction Study: 1 mg KRP-A218 Alone

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Part C: Drug-drug Interaction Study: 200 mg Itraconazole Alone

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Part C: Drug-drug Interaction Study: 1 mg KRP-A218 + 200 mg Itraconazole

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

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

Yoji Mimaki

Kyorin Pharmaceutical Co.,Ltd

Phone: +81-3-3525-4788

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