Trial Outcomes & Findings for Study of the Effects of Itraconazole and Rifampin on LOXO-305 in Healthy Participants (NCT NCT05134337)
NCT ID: NCT05134337
Last Updated: 2025-01-09
Results Overview
Cmax of LOXO-305
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on days 1 and 12
Results posted on
2025-01-09
Participant Flow
Participant milestones
| Measure |
Part 1 (LOXO-305/Itraconazole)
* Day 1: a single oral dose of 200 milligrams (mg) LOXO-305 was administered.
* Day 8: oral doses of 200 mg itraconazole was administered twice daily.
* Days 9 to 18: single oral dose of 200 mg itraconazole was administered once daily, and on Day 12 it was co-administered with a single oral dose of 200 mg LOXO-305.
|
Part 2 (LOXO 305/Rifampin)
* Day 1: a single oral dose of 200 mg LOXO-305 was administered
* Days 8 to 23: oral dose of 600 mg rifampin was administered once daily, and on Days 8 \& 17, it was co-administered with a single oral dose of 200 mg LOXO-305.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
12
|
|
Overall Study
Received at Least One Dose of Study Drug
|
15
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Part 1 (LOXO-305/Itraconazole)
* Day 1: a single oral dose of 200 milligrams (mg) LOXO-305 was administered.
* Day 8: oral doses of 200 mg itraconazole was administered twice daily.
* Days 9 to 18: single oral dose of 200 mg itraconazole was administered once daily, and on Day 12 it was co-administered with a single oral dose of 200 mg LOXO-305.
|
Part 2 (LOXO 305/Rifampin)
* Day 1: a single oral dose of 200 mg LOXO-305 was administered
* Days 8 to 23: oral dose of 600 mg rifampin was administered once daily, and on Days 8 \& 17, it was co-administered with a single oral dose of 200 mg LOXO-305.
|
|---|---|---|
|
Overall Study
Subject Discontinued Out of Precaution Due to Covid-19
|
3
|
0
|
Baseline Characteristics
Study of the Effects of Itraconazole and Rifampin on LOXO-305 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Part 1 (LOXO-305/Itraconazole)
n=15 Participants
* Day 1: a single oral dose of 200 milligrams (mg) LOXO-305 was administered.
* Day 8: oral doses of 200 mg itraconazole was administered twice daily.
* Days 9 to 18: single oral dose of 200 mg itraconazole was administered once daily, and on Day 12 it was co-administered with a single oral dose of 200 mg LOXO-305.
|
Part 2 (LOXO 305/Rifampin)
n=12 Participants
* Day 1: a single oral dose of 200 mg LOXO-305 was administered
* Days 8 to 23: oral dose of 600 mg rifampin was administered once daily, and on Days 8 \& 17, it was co-administered with a single oral dose of 200 mg LOXO-305.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.9 years
STANDARD_DEVIATION 9.13 • n=5 Participants
|
40.9 years
STANDARD_DEVIATION 7.79 • n=7 Participants
|
39.2 years
STANDARD_DEVIATION 8.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on days 1 and 12Population: All part 1 participants who received a dose of LOXO-305 on day 1, itraconazole with LOXO-305 on day 12, had at least one quantifiable plasma concentration of LOXO-305, and had at least one PK parameter computed for the specified timepoints. Participants were excluded from the analysis if they experienced an AE of vomiting that occurred at or before 2 times the median time to maximum observed plasma concentration (Tmax).
Cmax of LOXO-305
Outcome measures
| Measure |
Part 1 (LOXO-305/Itraconazole)
n=15 Participants
* Day 1: a single oral dose of 200 milligrams (mg) LOXO-305 was administered.
* Day 8: oral doses of 200 mg itraconazole was administered twice daily.
* Days 9 to 18: single oral dose of 200 mg itraconazole was administered once daily, and on Day 12 it was co-administered with a single oral dose of 200 mg LOXO-305.
|
|---|---|
|
Part 1: Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of LOXO-305
Day 1
|
4000 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 23.5
|
|
Part 1: Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of LOXO-305
Day 12
|
4100 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 17.2
|
PRIMARY outcome
Timeframe: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on days 1 and 12Population: All part 1 participants who received a dose of LOXO-305 on day 1, itraconazole with LOXO-305 on day 12, had at least one quantifiable plasma concentration of LOXO-305, and had at least one PK parameter computed for the specified timepoints. Participants were excluded from the analysis if they experienced an AE of vomiting that occurred at or before 2 times the median Tmax.
PK: AUC0-t of LOXO 305
Outcome measures
| Measure |
Part 1 (LOXO-305/Itraconazole)
n=15 Participants
* Day 1: a single oral dose of 200 milligrams (mg) LOXO-305 was administered.
* Day 8: oral doses of 200 mg itraconazole was administered twice daily.
* Days 9 to 18: single oral dose of 200 mg itraconazole was administered once daily, and on Day 12 it was co-administered with a single oral dose of 200 mg LOXO-305.
|
|---|---|
|
Part 1: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of LOXO 305
Day 1
|
80000 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 23.4
|
|
Part 1: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of LOXO 305
Day 12
|
122000 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 22.7
|
PRIMARY outcome
Timeframe: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on days 1 and 12Population: All part 1 participants who received a dose of LOXO-305 on day 1, itraconazole with LOXO-305 on day 12, had at least one quantifiable plasma concentration of LOXO-305, and had at least one PK parameter computed for the specified timepoints. Participants were excluded from the analysis if they experienced an AE of vomiting that occurred at or before 2 times the median Tmax.
AUC0-inf of LOXO-305
Outcome measures
| Measure |
Part 1 (LOXO-305/Itraconazole)
n=15 Participants
* Day 1: a single oral dose of 200 milligrams (mg) LOXO-305 was administered.
* Day 8: oral doses of 200 mg itraconazole was administered twice daily.
* Days 9 to 18: single oral dose of 200 mg itraconazole was administered once daily, and on Day 12 it was co-administered with a single oral dose of 200 mg LOXO-305.
|
|---|---|
|
Part 1: PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of LOXO-305
Day 1
|
80800 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 23.4
|
|
Part 1: PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of LOXO-305
Day 12
|
123000 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 23.4
|
PRIMARY outcome
Timeframe: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on days 1 and 17; Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose on day 8Population: All part 2 participants who received a dose of LOXO-305 on day 1, rifampin with LOXO-305 on day 8 and day 17, had at least one quantifiable plasma concentration of LOXO-305, and had at least one PK parameter computed for the specified timepoints. Participants were excluded from the analysis if they experienced an AE of vomiting that occurred at or before 2 times the median Tmax.
Cmax of LOXO-305
Outcome measures
| Measure |
Part 1 (LOXO-305/Itraconazole)
n=12 Participants
* Day 1: a single oral dose of 200 milligrams (mg) LOXO-305 was administered.
* Day 8: oral doses of 200 mg itraconazole was administered twice daily.
* Days 9 to 18: single oral dose of 200 mg itraconazole was administered once daily, and on Day 12 it was co-administered with a single oral dose of 200 mg LOXO-305.
|
|---|---|
|
Part 2: PK: Maximum Observed Plasma Concentration (Cmax) of LOXO-305
Day 1
|
4480 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 20.4
|
|
Part 2: PK: Maximum Observed Plasma Concentration (Cmax) of LOXO-305
Day 8
|
4170 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 15.6
|
|
Part 2: PK: Maximum Observed Plasma Concentration (Cmax) of LOXO-305
Day 17
|
2580 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 22.4
|
PRIMARY outcome
Timeframe: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on days 1 and 17; Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose on day 8Population: All part 2 participants who received a dose of LOXO-305 on day 1, rifampin with LOXO-305 on day 8 and day 17, had at least one quantifiable plasma concentration of LOXO-305, and had at least one PK parameter computed for the specified timepoints. Participants were excluded from the analysis if they experienced an AE of vomiting that occurred at or before 2 times the median Tmax.
PK: AUC0-t of LOXO 305
Outcome measures
| Measure |
Part 1 (LOXO-305/Itraconazole)
n=12 Participants
* Day 1: a single oral dose of 200 milligrams (mg) LOXO-305 was administered.
* Day 8: oral doses of 200 mg itraconazole was administered twice daily.
* Days 9 to 18: single oral dose of 200 mg itraconazole was administered once daily, and on Day 12 it was co-administered with a single oral dose of 200 mg LOXO-305.
|
|---|---|
|
Part 2: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of LOXO 305
Day 1
|
79700 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 17.6
|
|
Part 2: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of LOXO 305
Day 8
|
48500 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 14.7
|
|
Part 2: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of LOXO 305
Day 17
|
23000 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 20.1
|
PRIMARY outcome
Timeframe: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 hours postdose on days 1 and 17Population: All part 2 participants who received a dose of LOXO-305 on day 1, rifampin with LOXO-305 on day 17, had at least one quantifiable plasma concentration of LOXO-305, and had at least one PK parameter computed for the specified timepoints. Participants were excluded from the analysis if they experienced an AE of vomiting that occurred at or before 2 times the median Tmax.
AUC0-inf of LOXO-305
Outcome measures
| Measure |
Part 1 (LOXO-305/Itraconazole)
n=12 Participants
* Day 1: a single oral dose of 200 milligrams (mg) LOXO-305 was administered.
* Day 8: oral doses of 200 mg itraconazole was administered twice daily.
* Days 9 to 18: single oral dose of 200 mg itraconazole was administered once daily, and on Day 12 it was co-administered with a single oral dose of 200 mg LOXO-305.
|
|---|---|
|
Part 2: PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of LOXO-305
Day 1
|
80600 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 17.3
|
|
Part 2: PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of LOXO-305
Day 17
|
23600 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 19.8
|
PRIMARY outcome
Timeframe: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hours postdose on days 1 and 8Population: All part 2 participants who received a dose of LOXO-305 on day 1, rifampin with LOXO-305 on day 8, had at least one quantifiable plasma concentration of LOXO-305, and had at least one PK parameter computed for the specified timepoints. Participants were excluded from the analysis if they experienced an AE of vomiting that occurred at or before 2 times the median Tmax.
AUC0-24 of LOXO-305
Outcome measures
| Measure |
Part 1 (LOXO-305/Itraconazole)
n=12 Participants
* Day 1: a single oral dose of 200 milligrams (mg) LOXO-305 was administered.
* Day 8: oral doses of 200 mg itraconazole was administered twice daily.
* Days 9 to 18: single oral dose of 200 mg itraconazole was administered once daily, and on Day 12 it was co-administered with a single oral dose of 200 mg LOXO-305.
|
|---|---|
|
Part 2: PK: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours Postdose (AUC0-24) of LOXO-305
Day 1
|
50200 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 14.5
|
|
Part 2: PK: Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours Postdose (AUC0-24) of LOXO-305
Day 8
|
48600 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 14.7
|
Adverse Events
Part 1: 200 mg LOXO-305 Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1: 200 mg Itraconazole Alone
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1: 200 mg LOXO-305 + 200 mg Itraconazole
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 2: 200 mg LOXO-305 Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2: 200 mg LOXO-305 (Day 8) + 600 mg Rifampin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 2: 200 mg LOXO-305 (Day 17) + 600 mg Rifampin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part 1: 200 mg LOXO-305 Alone
n=15 participants at risk
Participants with adverse events observed during or after Day 1 LOXO-305 dosing and prior to Day 8 dosing were grouped under this arm.
|
Part 1: 200 mg Itraconazole Alone
n=12 participants at risk
Participants with adverse events observed during or after Day 8 itraconazole dosing and prior to Day 12 dosing were grouped under this arm.
|
Part 1: 200 mg LOXO-305 + 200 mg Itraconazole
n=12 participants at risk
Participants with adverse events observed during or after Day 12 LOXO-305 and itraconazole dosing were grouped under this arm.
|
Part 2: 200 mg LOXO-305 Alone
n=12 participants at risk
Participants with adverse events observed during or after Day 1 LOXO-305 dosing and prior to Day 8 dosing were grouped under this arm.
|
Part 2: 200 mg LOXO-305 (Day 8) + 600 mg Rifampin
n=12 participants at risk
Participants with adverse events observed during or after Day 8 LOXO-305 and rifampin dosing and prior to Day 17 dosing were grouped under this arm.
|
Part 2: 200 mg LOXO-305 (Day 17) + 600 mg Rifampin
n=12 participants at risk
Participants with adverse events observed during or after Day 17 LOXO-305 and rifampin dosing were grouped under this arm.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/15 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
0.00%
0/12 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
0.00%
0/12 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
0.00%
0/12 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
0.00%
0/12 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
8.3%
1/12 • Number of events 1 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/15 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
8.3%
1/12 • Number of events 1 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
0.00%
0/12 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
0.00%
0/12 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
0.00%
0/12 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
0.00%
0/12 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/15 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
8.3%
1/12 • Number of events 1 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
0.00%
0/12 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
0.00%
0/12 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
0.00%
0/12 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
8.3%
1/12 • Number of events 1 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/15 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
0.00%
0/12 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
0.00%
0/12 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
0.00%
0/12 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
0.00%
0/12 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
8.3%
1/12 • Number of events 1 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
8.3%
1/12 • Number of events 1 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
0.00%
0/12 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
0.00%
0/12 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
0.00%
0/12 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
0.00%
0/12 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/15 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
8.3%
1/12 • Number of events 1 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
0.00%
0/12 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
0.00%
0/12 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
0.00%
0/12 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
0.00%
0/12 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/15 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
0.00%
0/12 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
8.3%
1/12 • Number of events 1 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
0.00%
0/12 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
0.00%
0/12 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
0.00%
0/12 • Baseline to Follow-up (up to day 28 for Part 1; up to day 33 for Part 2)
All participants who received at least 1 dose of study drug. The adverse events were analyzed and reported according to the treatment sequences pre-specified in the statistical analysis plan (SAP).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60