Trial Outcomes & Findings for Single-dose Study in Two Panels of Healthy Adult Participants to Assess Immediate-Release and Dispersible Formulations of Pretomanid (NCT NCT04309656)
NCT ID: NCT04309656
Last Updated: 2024-07-24
Results Overview
Relative bioavailability will be determined separately for each panel using Cmax
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dose
Results posted on
2024-07-24
Participant Flow
Participant milestones
| Measure |
Panel 1: Pretomanid After Meal
Each participant will receive four single-dose treatments. Panel 1 will receive a required FDA standard high fat, high-calorie meal before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.
|
Panel 2: Pretomanid After Fast
Each participant will receive four single-dose treatments. Panel 2 will fast before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
24
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Single-dose Study in Two Panels of Healthy Adult Participants to Assess Immediate-Release and Dispersible Formulations of Pretomanid
Baseline characteristics by cohort
| Measure |
Panel 1: Pretomanid After Meal
n=24 Participants
Each participant will receive four single-dose treatments. Panel 1 will receive a required FDA standard high fat, high-calorie meal before dosing.
|
Panel 2: Pretomanid After Fast
n=24 Participants
Each participant will receive four single-dose treatments. Panel 2 will fast before dosing.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 8.5 • n=99 Participants
|
36.4 years
STANDARD_DEVIATION 7.2 • n=107 Participants
|
37.0 years
STANDARD_DEVIATION 7.82 • n=206 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Height at Screening
|
170.70 centimeter
STANDARD_DEVIATION 7.962 • n=99 Participants
|
170.96 centimeter
STANDARD_DEVIATION 11.953 • n=107 Participants
|
170.83 centimeter
STANDARD_DEVIATION 10.048 • n=206 Participants
|
|
Weight at Screening
|
79.06 kilogram
STANDARD_DEVIATION 11.601 • n=99 Participants
|
78.49 kilogram
STANDARD_DEVIATION 13.633 • n=107 Participants
|
78.77 kilogram
STANDARD_DEVIATION 12.526 • n=206 Participants
|
|
BMI at Screening
|
27.08 kilogram per meter squared
STANDARD_DEVIATION 2.882 • n=99 Participants
|
26.76 kilogram per meter squared
STANDARD_DEVIATION 2.996 • n=107 Participants
|
26.92 kilogram per meter squared
STANDARD_DEVIATION 2.913 • n=206 Participants
|
PRIMARY outcome
Timeframe: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dosePopulation: Quantifiable predose concentrations that were below 5% of the respective Cmax values were included in the pharmacokinetic analyses without adjustment. Data for subjects with quantifiable predose concentrations that were above 5% of the respective Cmax values were excluded from concentration-time descriptive statistics and mean concentration-time profiles
Relative bioavailability will be determined separately for each panel using Cmax
Outcome measures
| Measure |
Panel 1: Pretomanid After Meal
n=24 Participants
Each participant will receive four single-dose treatments. Panel 1 will receive a meal before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.
|
Panel 2: Pretomanid After Fast
n=24 Participants
Each participant will receive four single-dose treatments. Panel 2 will fast before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.
|
Treatment C Fed and Fasted
Each participant will receive four single-dose treatments. Panel 1 will receive a meal before dosing.
Treatment C (test) = single 50-mg dispersible tablet, orally administered.
|
Treatment D Fed and Fasted
Each participant will receive four single-dose treatments. Panel 1 will receive a meal before dosing.
Treatment D (test) = single 10-mg dispersible tablet, orally administered.
|
Panel 2:Treatment A
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
Panel 2: Treatment B
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
Panel 2: Treatment C
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
Panel 2: Treatment D
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
|---|---|---|---|---|---|---|---|---|
|
Relative Bioavailability - Cmax
Treatment C
|
389 ng/mL
Standard Deviation 58.8
|
427 ng/mL
Standard Deviation 111
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Relative Bioavailability - Cmax
Treatment D
|
76.7 ng/mL
Standard Deviation 14.2
|
110 ng/mL
Standard Deviation 20.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Relative Bioavailability - Cmax
Treatment A
|
2170 ng/mL
Standard Deviation 484
|
1180 ng/mL
Standard Deviation 401
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Relative Bioavailability - Cmax
Treatment B
|
1850 ng/mL
Standard Deviation 354
|
1090 ng/mL
Standard Deviation 334
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dosePopulation: Quantifiable predose concentrations that were below 5% of the respective Cmax values were included in the pharmacokinetic analyses without adjustment. Data for subjects with quantifiable predose concentrations that were above 5% of the respective Cmax values were excluded from concentration-time descriptive statistics and mean concentration-time profiles
Relative bioavailability will be determined separately for each panel using AUC 0-t (area under the time vs concentration curve from time 0 to time t : h\*ng/mL)
Outcome measures
| Measure |
Panel 1: Pretomanid After Meal
n=24 Participants
Each participant will receive four single-dose treatments. Panel 1 will receive a meal before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.
|
Panel 2: Pretomanid After Fast
n=24 Participants
Each participant will receive four single-dose treatments. Panel 2 will fast before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.
|
Treatment C Fed and Fasted
Each participant will receive four single-dose treatments. Panel 1 will receive a meal before dosing.
Treatment C (test) = single 50-mg dispersible tablet, orally administered.
|
Treatment D Fed and Fasted
Each participant will receive four single-dose treatments. Panel 1 will receive a meal before dosing.
Treatment D (test) = single 10-mg dispersible tablet, orally administered.
|
Panel 2:Treatment A
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
Panel 2: Treatment B
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
Panel 2: Treatment C
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
Panel 2: Treatment D
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
|---|---|---|---|---|---|---|---|---|
|
Relative Bioavailability - AUC 0-t
Treatment D
|
2040 h*ng/mL
Standard Deviation 514
|
2460 h*ng/mL
Standard Deviation 513
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Relative Bioavailability - AUC 0-t
Treatment A
|
54900 h*ng/mL
Standard Deviation 10700
|
32900 h*ng/mL
Standard Deviation 7580
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Relative Bioavailability - AUC 0-t
Treatment B
|
55200 h*ng/mL
Standard Deviation 10800
|
30200 h*ng/mL
Standard Deviation 9030
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Relative Bioavailability - AUC 0-t
Treatment C
|
12300 h*ng/mL
Standard Deviation 2790
|
10900 h*ng/mL
Standard Deviation 3150
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dosePopulation: Quantifiable predose concentrations that were below 5% of the respective Cmax values were included in the pharmacokinetic analyses without adjustment. Data for subjects with quantifiable predose concentrations that were above 5% of the respective Cmax values were excluded from concentration-time descriptive statistics and mean concentration-time profiles
Relative bioavailability will be determined separately for each panel using AUC 0-inf (area under the time vs concentration curve from time 0 to infinite time)
Outcome measures
| Measure |
Panel 1: Pretomanid After Meal
n=24 Participants
Each participant will receive four single-dose treatments. Panel 1 will receive a meal before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.
|
Panel 2: Pretomanid After Fast
n=24 Participants
Each participant will receive four single-dose treatments. Panel 2 will fast before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.
|
Treatment C Fed and Fasted
Each participant will receive four single-dose treatments. Panel 1 will receive a meal before dosing.
Treatment C (test) = single 50-mg dispersible tablet, orally administered.
|
Treatment D Fed and Fasted
Each participant will receive four single-dose treatments. Panel 1 will receive a meal before dosing.
Treatment D (test) = single 10-mg dispersible tablet, orally administered.
|
Panel 2:Treatment A
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
Panel 2: Treatment B
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
Panel 2: Treatment C
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
Panel 2: Treatment D
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
|---|---|---|---|---|---|---|---|---|
|
Relative Bioavailability - AUC 0-inf
Treatment A
|
57400 h*ng/mL
Standard Deviation 12300
|
34700 h*ng/mL
Standard Deviation 8330
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Relative Bioavailability - AUC 0-inf
Treatment B
|
57900 h*ng/mL
Standard Deviation 12400
|
31900 h*ng/mL
Standard Deviation 10200
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Relative Bioavailability - AUC 0-inf
Treatment C
|
12700 h*ng/mL
Standard Deviation 3210
|
11400 h*ng/mL
Standard Deviation 3440
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Relative Bioavailability - AUC 0-inf
Treatment D
|
2100 h*ng/mL
Standard Deviation 552
|
2530 h*ng/mL
Standard Deviation 551
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dosePopulation: Ratio(%) = Geometric Mean (Test)/Geometric Mean (Ref). Quantifiable predose concentrations that were below 5% of the respective Cmax values were included in the pharmacokinetic analyses without adjustment. Data for subjects with quantifiable predose concentrations that were above 5% of the respective Cmax values were excluded from concentration-time descriptive statistics and mean concentration-time profiles
Food effect on bioavailability will be determined across panels using Cmax. Reported in Ratio(%) of the Geometric Mean (Fed)/Geometric Mean (Fasted) based on Least Squares Mean of log-transformed parameter values (ng/mL)
Outcome measures
| Measure |
Panel 1: Pretomanid After Meal
n=48 Participants
Each participant will receive four single-dose treatments. Panel 1 will receive a meal before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.
|
Panel 2: Pretomanid After Fast
n=48 Participants
Each participant will receive four single-dose treatments. Panel 2 will fast before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.
|
Treatment C Fed and Fasted
n=46 Participants
Each participant will receive four single-dose treatments. Panel 1 will receive a meal before dosing.
Treatment C (test) = single 50-mg dispersible tablet, orally administered.
|
Treatment D Fed and Fasted
n=34 Participants
Each participant will receive four single-dose treatments. Panel 1 will receive a meal before dosing.
Treatment D (test) = single 10-mg dispersible tablet, orally administered.
|
Panel 2:Treatment A
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
Panel 2: Treatment B
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
Panel 2: Treatment C
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
Panel 2: Treatment D
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
|---|---|---|---|---|---|---|---|---|
|
Food Effect - Ratio of Cmax Fed Vs Fasted
|
187.65 Ratio (%)
Interval 165.9 to 212.25
|
173.24 Ratio (%)
Interval 153.26 to 195.82
|
93.25 Ratio (%)
Interval 83.16 to 104.56
|
69.38 Ratio (%)
Interval 61.96 to 77.68
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post dosePopulation: Ratio(%) = Geometric Mean (Test)/Geometric Mean (Ref). Quantifiable predose concentrations that were below 5% of the respective Cmax values were included in the pharmacokinetic analyses without adjustment. Data for subjects with quantifiable predose concentrations that were above 5% of the respective Cmax values were excluded from concentration-time descriptive statistics and mean concentration-time profiles
Food effect on bioavailability was assessed across panels based on the 90% confidence intervals (CIs) for estimates of the geometric mean ratios between AUC 0-t of fed versus fasted across panels. An analysis of variance was used for each treatment with panel as the fixed effect.
Outcome measures
| Measure |
Panel 1: Pretomanid After Meal
n=48 Participants
Each participant will receive four single-dose treatments. Panel 1 will receive a meal before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.
|
Panel 2: Pretomanid After Fast
n=48 Participants
Each participant will receive four single-dose treatments. Panel 2 will fast before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.
|
Treatment C Fed and Fasted
n=46 Participants
Each participant will receive four single-dose treatments. Panel 1 will receive a meal before dosing.
Treatment C (test) = single 50-mg dispersible tablet, orally administered.
|
Treatment D Fed and Fasted
n=34 Participants
Each participant will receive four single-dose treatments. Panel 1 will receive a meal before dosing.
Treatment D (test) = single 10-mg dispersible tablet, orally administered.
|
Panel 2:Treatment A
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
Panel 2: Treatment B
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
Panel 2: Treatment C
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
Panel 2: Treatment D
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
|---|---|---|---|---|---|---|---|---|
|
Food Effect - Ratio of AUC 0-t Fed Vs Fasted
|
167.96 Ratio (%)
Interval 151.4 to 186.33
|
188.36 Ratio (%)
Interval 165.6 to 214.26
|
114.09 Ratio (%)
Interval 99.7 to 130.55
|
81.74 Ratio (%)
Interval 71.53 to 93.42
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: intake (pre-dose), and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post doseFood effect on bioavailability was assessed across panels based on the 90% confidence intervals (CIs) for estimates of the geometric mean ratios between AUC 0-inf of fed versus fasted across panels. An analysis of variance was used for each treatment with panel as the fixed effect
Outcome measures
| Measure |
Panel 1: Pretomanid After Meal
n=48 Participants
Each participant will receive four single-dose treatments. Panel 1 will receive a meal before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.
|
Panel 2: Pretomanid After Fast
n=48 Participants
Each participant will receive four single-dose treatments. Panel 2 will fast before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.
|
Treatment C Fed and Fasted
n=46 Participants
Each participant will receive four single-dose treatments. Panel 1 will receive a meal before dosing.
Treatment C (test) = single 50-mg dispersible tablet, orally administered.
|
Treatment D Fed and Fasted
n=34 Participants
Each participant will receive four single-dose treatments. Panel 1 will receive a meal before dosing.
Treatment D (test) = single 10-mg dispersible tablet, orally administered.
|
Panel 2:Treatment A
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
Panel 2: Treatment B
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
Panel 2: Treatment C
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
Panel 2: Treatment D
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
|---|---|---|---|---|---|---|---|---|
|
Food Effect - Ratio of AUC 0-inf Fed Vs Fasted
|
166.38 Ratio (%)
Interval 149.07 to 185.69
|
187.54 Ratio (%)
Interval 163.44 to 215.2
|
113.58 Ratio (%)
Interval 98.52 to 130.95
|
81.57 Ratio (%)
Interval 71.07 to 93.61
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: throughout the study, approximately 33 daysPopulation: All participants randomized
All listed adverse events (AEs) are treatment emergent adverse events (TEAE) which are defined as AEs that started or worsened at or after the first administration of IMP up to and including
Outcome measures
| Measure |
Panel 1: Pretomanid After Meal
n=24 Participants
Each participant will receive four single-dose treatments. Panel 1 will receive a meal before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.
|
Panel 2: Pretomanid After Fast
n=24 Participants
Each participant will receive four single-dose treatments. Panel 2 will fast before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.
|
Treatment C Fed and Fasted
n=24 Participants
Each participant will receive four single-dose treatments. Panel 1 will receive a meal before dosing.
Treatment C (test) = single 50-mg dispersible tablet, orally administered.
|
Treatment D Fed and Fasted
n=24 Participants
Each participant will receive four single-dose treatments. Panel 1 will receive a meal before dosing.
Treatment D (test) = single 10-mg dispersible tablet, orally administered.
|
Panel 2:Treatment A
n=24 Participants
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
Panel 2: Treatment B
n=24 Participants
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
Panel 2: Treatment C
n=24 Participants
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
Panel 2: Treatment D
n=24 Participants
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
|---|---|---|---|---|---|---|---|---|
|
Adverse Events - Overall Incidence
|
5 Participants
|
9 Participants
|
2 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
Adverse Events
Panel 1: Treatment A
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Panel 1: Treatment B
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Panel 1: Treatment C
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Panel 1: Treatment D
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Panel 2:Treatment A
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Panel 2: Treatment B
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Panel 2: Treatment C
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Panel 2: Treatment D
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Panel 1: Treatment A
n=24 participants at risk
Each participant received four single-dose treatments. Panel 1 received a meal before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.
|
Panel 1: Treatment B
n=24 participants at risk
Each participant received four single-dose treatments. Panel 1 received a meal before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.
|
Panel 1: Treatment C
n=24 participants at risk
Each participant received four single-dose treatments. Panel 1 received a meal before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.
|
Panel 1: Treatment D
n=24 participants at risk
Each participant received four single-dose treatments. Panel 1 received a meal before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered.
|
Panel 2:Treatment A
n=24 participants at risk
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
Panel 2: Treatment B
n=24 participants at risk
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
Panel 2: Treatment C
n=24 participants at risk
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
Panel 2: Treatment D
n=24 participants at risk
Each participant received four single-dose treatments. Panel 2 fasted before dosing.
Pretomanid: 1) Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
2\) Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
3\) Treatment C (test) = single 50-mg dispersible tablet, orally administered. 4) Treatment D (test) = single 10-mg dispersible tablet, orally administered
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
4.2%
1/24 • Number of events 1 • Day 1 to Day 33
|
4.2%
1/24 • Number of events 1 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
8.3%
2/24 • Number of events 2 • Day 1 to Day 33
|
4.2%
1/24 • Number of events 1 • Day 1 to Day 33
|
4.2%
1/24 • Number of events 1 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
|
Cardiac disorders
Postural orthostatic tachycardia syndrome
|
12.5%
3/24 • Number of events 4 • Day 1 to Day 33
|
12.5%
3/24 • Number of events 6 • Day 1 to Day 33
|
4.2%
1/24 • Number of events 2 • Day 1 to Day 33
|
4.2%
1/24 • Number of events 1 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
|
Nervous system disorders
Headache
|
4.2%
1/24 • Number of events 1 • Day 1 to Day 33
|
8.3%
2/24 • Number of events 2 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
8.3%
2/24 • Number of events 2 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
4.2%
1/24 • Number of events 1 • Day 1 to Day 33
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/24 • Day 1 to Day 33
|
8.3%
2/24 • Number of events 2 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
4.2%
1/24 • Number of events 1 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
|
Cardiac disorders
Palpitations
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
4.2%
1/24 • Number of events 1 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
|
Eye disorders
Vision blurred
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
4.2%
1/24 • Number of events 1 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/24 • Day 1 to Day 33
|
4.2%
1/24 • Number of events 1 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
|
General disorders
Fatigue
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
4.2%
1/24 • Number of events 1 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
4.2%
1/24 • Number of events 1 • Day 1 to Day 33
|
|
Infections and infestations
Folliculitis
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
4.2%
1/24 • Number of events 1 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
4.2%
1/24 • Number of events 1 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/24 • Day 1 to Day 33
|
4.2%
1/24 • Number of events 1 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
4.2%
1/24 • Number of events 1 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
4.2%
1/24 • Number of events 1 • Day 1 to Day 33
|
4.2%
1/24 • Number of events 1 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
4.2%
1/24 • Number of events 1 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
4.2%
1/24 • Number of events 1 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
4.2%
1/24 • Number of events 1 • Day 1 to Day 33
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
4.2%
1/24 • Number of events 1 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
4.2%
1/24 • Number of events 1 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
4.2%
1/24 • Number of events 1 • Day 1 to Day 33
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
4.2%
1/24 • Number of events 1 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
0.00%
0/24 • Day 1 to Day 33
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place