Trial Outcomes & Findings for A Study of the Effects of Food and Cobicistat on Plixorafenib Pharmacokinetics in Healthy Participants. (NCT NCT06385119)
NCT ID: NCT06385119
Last Updated: 2026-03-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
28 participants
Primary outcome timeframe
Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period.
Results posted on
2026-03-27
Participant Flow
1 Clinical site located in the United States.
Participant milestones
| Measure |
Part A: Sequence 1
Participants that completed the following treatment periods in sequence:
1. \- Treatment Period 1 (900 mg plixorafenib (Fasted))
2. \- Treatment Period 2 (900 mg plixorafenib + 150 mg cobicistat (Fasted))
3. \- Treatment Period 3 (900 mg plixorafenib + 150 mg cobicistat (Fed))
|
Part A: Sequence 2
Participants that completed the following treatment periods in sequence:
1. \- Treatment Period 2 (900 mg plixorafenib + 150 mg cobicistat (Fasted))
2. \- Treatment Period 3 (900 mg plixorafenib + 150 mg cobicistat (Fed))
3. \- Treatment Period 1 (900 mg plixorafenib (Fasted))
|
Part A: Sequence 3
Participants that completed the following treatment periods in sequence:
1. \- Treatment Period 3 (900 mg plixorafenib + 150 mg cobicistat (Fed))
2. \- Treatment Period 2 (900 mg plixorafenib + 150 mg cobicistat (Fasted))
3. \- Treatment Period 1 (900 mg plixorafenib (Fasted))
|
Part A: Sequence 4
Participants that completed the following treatment periods in sequence:
1. \- Treatment Period 2 (900 mg plixorafenib + 150 mg cobicistat (Fasted))
2. \- Treatment Period 1 (900 mg plixorafenib (Fasted))
3. \- Treatment Period 3 (900 mg plixorafenib + 150 mg cobicistat (Fed))
|
Part A: Sequence 5
Participants that completed the following treatment periods in sequence:
1. \- Treatment Period 3 (900 mg plixorafenib + 150 mg cobicistat (Fed))
2. \- Treatment Period 1 (900 mg plixorafenib (Fasted))
3. \- Treatment Period 2 (900 mg plixorafenib + 150 mg cobicistat (Fasted))
|
Part A: Sequence 6
Participants that completed the following treatment periods in sequence:
1. \- Treatment Period 1 (900 mg plixorafenib (Fasted))
2. \- Treatment Period 3 (900 mg plixorafenib + 150 mg cobicistat (Fed))
3. \- Treatment Period 2 (900 mg plixorafenib + 150 mg cobicistat (Fasted))
|
Part B: Sequence 1
Participants that completed the following treatment periods in sequence:
1. \- Treatment Period A (900 mg plixorafenib (Fasted))
2. \- Treatment Period C (900 mg plixorafenib (Fed with Low-Fat meal)\]
3. \- Treatment Period D (900 mg plixorafenib + 150 mg cobicistat ((Fed with Low-Fat meal))
|
Part B: Sequence 2
Participants that completed the following treatment periods in sequence:
1. \- Treatment Period B (900 mg plixorafenib (Fed with High-Fat meal))
2. \- Treatment Period D (900 mg plixorafenib + 150 mg cobicistat ((Fed with Low-Fat meal))
3. \- Treatment Period A (900 mg plixorafenib (Fasted))
|
Part B: Sequence 3
Participants that completed the following treatment periods in sequence:
1. \- Treatment Period D (900 mg plixorafenib + 150 mg cobicistat (Fed with Low-Fat meal))
2. \- Treatment Period B (900 mg plixorafenib (Fed with High-Fat meal))
3. \- Treatment Period C (900 mg plixorafenib (Fed with Low-Fat meal))
|
Part B: Sequence 4
Participants that completed the following treatment periods in sequence:
1. \- Treatment Period C (900 mg plixorafenib (Fed with Low-Fat meal))
2. \- Treatment Period A (900 mg plixorafenib (Fasted))
3. \- Treatment Period B (900 mg plixorafenib (Fed with High-Fat meal))
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
2
|
2
|
2
|
2
|
4
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
2
|
4
|
4
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of the Effects of Food and Cobicistat on Plixorafenib Pharmacokinetics in Healthy Participants.
Baseline characteristics by cohort
| Measure |
Part A: Sequence 1
n=2 Participants
Participants that completed the following treatment periods in sequence:
1. \- Treatment Period 1 (900 mg plixorafenib (Fasted))
2. \- Treatment Period 2 (900 mg plixorafenib + 150 mg cobicistat (Fasted))
3. \- Treatment Period 3 (900 mg plixorafenib + 150 mg cobicistat (Fed))
|
Part A: Sequence 2
n=2 Participants
Participants that completed the following treatment periods in sequence:
1. \- Treatment Period 2 (900 mg plixorafenib + 150 mg cobicistat (Fasted))
2. \- Treatment Period 3 (900 mg plixorafenib + 150 mg cobicistat (Fed))
3. \- Treatment Period 1 (900 mg plixorafenib (Fasted))
|
Part A: Sequence 3
n=2 Participants
Participants that completed the following treatment periods in sequence:
1. \- Treatment Period 3 (900 mg plixorafenib + 150 mg cobicistat (Fed))
2. \- Treatment Period 2 (900 mg plixorafenib + 150 mg cobicistat (Fasted))
3. \- Treatment Period 1 (900 mg plixorafenib (Fasted))
|
Part A: Sequence 4
n=2 Participants
Participants that completed the following treatment periods in sequence:
1. \- Treatment Period 2 (900 mg plixorafenib + 150 mg cobicistat (Fasted))
2. \- Treatment Period 1 (900 mg plixorafenib (Fasted))
3. \- Treatment Period 3 (900 mg plixorafenib + 150 mg cobicistat (Fed))
|
Part A: Sequence 5
n=2 Participants
Participants that completed the following treatment periods in sequence:
1. \- Treatment Period 3 (900 mg plixorafenib + 150 mg cobicistat (Fed))
2. \- Treatment Period 1 (900 mg plixorafenib (Fasted))
3. \- Treatment Period 2 (900 mg plixorafenib + 150 mg cobicistat (Fasted))
|
Part A: Sequence 6
n=2 Participants
Participants that completed the following treatment periods in sequence:
1. \- Treatment Period 1 (900 mg plixorafenib (Fasted))
2. \- Treatment Period 3 (900 mg plixorafenib + 150 mg cobicistat (Fed))
3. \- Treatment Period 2 (900 mg plixorafenib + 150 mg cobicistat (Fasted))
|
Part B: Sequence 1
n=4 Participants
Participants that completed the following treatment periods in sequence:
1. \- Treatment Period A (900 mg plixorafenib (Fasted))
2. \- Treatment Period C (900 mg plixorafenib (Fed with Low-Fat meal)\]
3. \- Treatment Period D (900 mg plixorafenib + 150 mg cobicistat ((Fed with Low-Fat meal))
|
Part B: Sequence 2
n=4 Participants
Participants that completed the following treatment periods in sequence:
1. \- Treatment Period B (900 mg plixorafenib (Fed with High-Fat meal))
2. \- Treatment Period D (900 mg plixorafenib + 150 mg cobicistat ((Fed with Low-Fat meal))
3. \- Treatment Period A (900 mg plixorafenib (Fasted))
|
Part B: Sequence 3
n=4 Participants
Participants that completed the following treatment periods in sequence:
1. \- Treatment Period D (900 mg plixorafenib + 150 mg cobicistat (Fed with Low-Fat meal))
2. \- Treatment Period B (900 mg plixorafenib (Fed with High-Fat meal))
3. \- Treatment Period C (900 mg plixorafenib (Fed with Low-Fat meal))
|
Part B: Sequence 4
n=4 Participants
Participants that completed the following treatment periods in sequence:
1. \- Treatment Period C (900 mg plixorafenib (Fed with Low-Fat meal))
2. \- Treatment Period A (900 mg plixorafenib (Fasted))
3. \- Treatment Period B (900 mg plixorafenib (Fed with High-Fat meal))
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Sex: Female, Male
Male
|
2 Participants
n=56 Participants
|
2 Participants
n=62 Participants
|
2 Participants
n=123 Participants
|
2 Participants
n=53 Participants
|
1 Participants
n=654 Participants
|
1 Participants
n=120 Participants
|
4 Participants
n=18 Participants
|
2 Participants
n=12 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=93 Participants
|
18 Participants
n=8 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=93 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=56 Participants
|
2 Participants
n=62 Participants
|
2 Participants
n=123 Participants
|
2 Participants
n=53 Participants
|
2 Participants
n=654 Participants
|
2 Participants
n=120 Participants
|
4 Participants
n=18 Participants
|
4 Participants
n=12 Participants
|
4 Participants
n=6 Participants
|
4 Participants
n=93 Participants
|
28 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
0 Participants
n=654 Participants
|
0 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=93 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
1 Participants
n=654 Participants
|
1 Participants
n=120 Participants
|
0 Participants
n=18 Participants
|
2 Participants
n=12 Participants
|
4 Participants
n=6 Participants
|
2 Participants
n=93 Participants
|
10 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=56 Participants
|
1 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
0 Participants
n=53 Participants
|
1 Participants
n=654 Participants
|
1 Participants
n=120 Participants
|
2 Participants
n=18 Participants
|
2 Participants
n=12 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=93 Participants
|
16 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=56 Participants
|
1 Participants
n=62 Participants
|
1 Participants
n=123 Participants
|
2 Participants
n=53 Participants
|
1 Participants
n=654 Participants
|
1 Participants
n=120 Participants
|
2 Participants
n=18 Participants
|
2 Participants
n=12 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=93 Participants
|
12 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=56 Participants
|
2 participants
n=62 Participants
|
2 participants
n=123 Participants
|
2 participants
n=53 Participants
|
2 participants
n=654 Participants
|
2 participants
n=120 Participants
|
4 participants
n=18 Participants
|
4 participants
n=12 Participants
|
4 participants
n=6 Participants
|
4 participants
n=93 Participants
|
28 participants
n=8 Participants
|
|
Height
|
185.55 centimeters
STANDARD_DEVIATION 3.748 • n=56 Participants
|
174.65 centimeters
STANDARD_DEVIATION 3.323 • n=62 Participants
|
177.30 centimeters
STANDARD_DEVIATION 4.808 • n=123 Participants
|
184.4 centimeters
STANDARD_DEVIATION 13.294 • n=53 Participants
|
166.10 centimeters
STANDARD_DEVIATION 9.192 • n=654 Participants
|
166.40 centimeters
STANDARD_DEVIATION 4.808 • n=120 Participants
|
176.48 centimeters
STANDARD_DEVIATION 7.121 • n=18 Participants
|
165.55 centimeters
STANDARD_DEVIATION 7.059 • n=12 Participants
|
174.25 centimeters
STANDARD_DEVIATION 5.482 • n=6 Participants
|
170.38 centimeters
STANDARD_DEVIATION 9.404 • n=93 Participants
|
168.12 centimeters
STANDARD_DEVIATION 30.40 • n=8 Participants
|
|
Weight
|
98.75 kilograms
STANDARD_DEVIATION 5.728 • n=56 Participants
|
83.55 kilograms
STANDARD_DEVIATION 2.475 • n=62 Participants
|
83.00 kilograms
STANDARD_DEVIATION 0.849 • n=123 Participants
|
91.95 kilograms
STANDARD_DEVIATION 21.001 • n=53 Participants
|
70.70 kilograms
STANDARD_DEVIATION 9.334 • n=654 Participants
|
73.50 kilograms
STANDARD_DEVIATION 11.597 • n=120 Participants
|
83.35 kilograms
STANDARD_DEVIATION 11.148 • n=18 Participants
|
74.95 kilograms
STANDARD_DEVIATION 4.664 • n=12 Participants
|
82.03 kilograms
STANDARD_DEVIATION 10.136 • n=6 Participants
|
72.65 kilograms
STANDARD_DEVIATION 9.941 • n=93 Participants
|
80.53 kilograms
STANDARD_DEVIATION 11.03 • n=8 Participants
|
|
Body Mass Index (BMI)
|
28.65 kg/m2
STANDARD_DEVIATION 0.495 • n=56 Participants
|
27.40 kg/m2
STANDARD_DEVIATION 1.838 • n=62 Participants
|
26.40 kg/m2
STANDARD_DEVIATION 1.131 • n=123 Participants
|
26.80 kg/m2
STANDARD_DEVIATION 2.263 • n=53 Participants
|
25.55 kg/m2
STANDARD_DEVIATION 0.495 • n=654 Participants
|
26.45 kg/m2
STANDARD_DEVIATION 2.616 • n=120 Participants
|
26.83 kg/m2
STANDARD_DEVIATION 3.746 • n=18 Participants
|
27.40 kg/m2
STANDARD_DEVIATION 1.903 • n=12 Participants
|
26.90 kg/m2
STANDARD_DEVIATION 1.780 • n=6 Participants
|
24.94 kg/m2
STANDARD_DEVIATION 2.450 • n=93 Participants
|
26.68 kg/m2
STANDARD_DEVIATION 2.098 • n=8 Participants
|
PRIMARY outcome
Timeframe: First dose of Plixorafenib to day 19 (Treatment Period 3).Number of Participants with at least one reported Treatment Emergent Adverse Events (TEAEs).
Outcome measures
| Measure |
Treatment D
n=12 Participants
Treatment D: 900 mg plixorafenib administered with 150 mg cobicistat following a low-fat meal (fed state-low-fat meal).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment 1
n=12 Participants
Treatment 1: 900 mg plixorafenib (6 × 150 mg tablets) administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
|
Treatment 2
n=12 Participants
Treatment 2: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment 3
n=12 Participants
Treatment 3: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered following a high fat, high caloric meal (fed state).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment A
n=12 Participants
Treatment A: 900 mg plixorafenib administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
|
Treatment B
n=12 Participants
Treatment B: 900 mg plixorafenib administered following a high-fat high caloric meal (fed state-high fat meal).
Plixorafenib: Oral Tablet
|
Treatment C
n=12 Participants
Treatment C: 900 mg plixorafenib administered following a low-fat meal (fed state-low-fat meal).
Plixorafenib: Oral Tablet
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs).
Adverse Event of Special Interest (AESI)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs).
Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs).
TEAE Leading to Early Study Discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs).
Any treatment Emergent Adverse Events (TEAE)
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs).
Related to Plixorafenib
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs).
Related to Cobicistat
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs).
Grade ≥3 TEAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs).
Serious Adverse Event (SAE)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period.Population: All participants enrolled into Part A and Part B who received 900mg plixorafenib.
Area under the concentration versus time curve from time 0 to the last quantifiable concentration within the dosing interval.
Outcome measures
| Measure |
Treatment D
n=12 Participants
Treatment D: 900 mg plixorafenib administered with 150 mg cobicistat following a low-fat meal (fed state-low-fat meal).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment 1
n=12 Participants
Treatment 1: 900 mg plixorafenib (6 × 150 mg tablets) administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
|
Treatment 2
n=12 Participants
Treatment 2: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment 3
n=12 Participants
Treatment 3: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered following a high fat, high caloric meal (fed state).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment A
n=12 Participants
Treatment A: 900 mg plixorafenib administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
|
Treatment B
n=12 Participants
Treatment B: 900 mg plixorafenib administered following a high-fat high caloric meal (fed state-high fat meal).
Plixorafenib: Oral Tablet
|
Treatment C
n=12 Participants
Treatment C: 900 mg plixorafenib administered following a low-fat meal (fed state-low-fat meal).
Plixorafenib: Oral Tablet
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to the Last Quantifiable Concentration (AUC0-t).
|
474.421 h*µg/mL
Standard Deviation 155.6191
|
49.02 h*µg/mL
Standard Deviation 25.387
|
168.31 h*µg/mL
Standard Deviation 90.7189
|
513.686 h*µg/mL
Standard Deviation 115.459
|
72.36 h*µg/mL
Standard Deviation 41.4522
|
120.376 h*µg/mL
Standard Deviation 44.2094
|
173.517 h*µg/mL
Standard Deviation 65.8967
|
PRIMARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period.Population: All participants enrolled into Part A and Part B who received 900mg plixorafenib. Treatment 1 had an adjusted correlation coefficient (R2) \< 0.75 and the value was excluded from summary statistics.
Area under the concentration versus time curve from time 0 extrapolated to infinity calculated as AUC0-t + Clast/λz, where Clast is the last quantifiable concentration and lambda z is the terminal rate constant.
Outcome measures
| Measure |
Treatment D
n=12 Participants
Treatment D: 900 mg plixorafenib administered with 150 mg cobicistat following a low-fat meal (fed state-low-fat meal).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment 1
n=11 Participants
Treatment 1: 900 mg plixorafenib (6 × 150 mg tablets) administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
|
Treatment 2
n=12 Participants
Treatment 2: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment 3
n=12 Participants
Treatment 3: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered following a high fat, high caloric meal (fed state).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment A
n=12 Participants
Treatment A: 900 mg plixorafenib administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
|
Treatment B
n=12 Participants
Treatment B: 900 mg plixorafenib administered following a high-fat high caloric meal (fed state-high fat meal).
Plixorafenib: Oral Tablet
|
Treatment C
n=12 Participants
Treatment C: 900 mg plixorafenib administered following a low-fat meal (fed state-low-fat meal).
Plixorafenib: Oral Tablet
|
|---|---|---|---|---|---|---|---|
|
AUC From Time 0 Extrapolated to Infinity (AUC0-inf).
|
474.967 h*µg/mL
Standard Deviation 155.8864
|
46.588 h*µg/mL
Standard Deviation 24.1108
|
169.316 h*µg/mL
Standard Deviation 91.6553
|
514.824 h*µg/mL
Standard Deviation 115.8643
|
74.02 h*µg/mL
Standard Deviation 42.9613
|
121.883 h*µg/mL
Standard Deviation 45.6913
|
173.964 h*µg/mL
Standard Deviation 66.1065
|
PRIMARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period.Population: All participants enrolled into Part A and Part B who received 900mg plixorafenib.
Maximum observed concentration, obtained by inspection.
Outcome measures
| Measure |
Treatment D
n=12 Participants
Treatment D: 900 mg plixorafenib administered with 150 mg cobicistat following a low-fat meal (fed state-low-fat meal).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment 1
n=12 Participants
Treatment 1: 900 mg plixorafenib (6 × 150 mg tablets) administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
|
Treatment 2
n=12 Participants
Treatment 2: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment 3
n=12 Participants
Treatment 3: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered following a high fat, high caloric meal (fed state).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment A
n=12 Participants
Treatment A: 900 mg plixorafenib administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
|
Treatment B
n=12 Participants
Treatment B: 900 mg plixorafenib administered following a high-fat high caloric meal (fed state-high fat meal).
Plixorafenib: Oral Tablet
|
Treatment C
n=12 Participants
Treatment C: 900 mg plixorafenib administered following a low-fat meal (fed state-low-fat meal).
Plixorafenib: Oral Tablet
|
|---|---|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax).
|
66.12 µg/mL
Standard Deviation 14.655
|
11.481 µg/mL
Standard Deviation 6.6171
|
23.272 µg/mL
Standard Deviation 11.8014
|
49 µg/mL
Standard Deviation 17.228
|
12.416 µg/mL
Standard Deviation 4.2213
|
24.61 µg/mL
Standard Deviation 8.007
|
28.13 µg/mL
Standard Deviation 13.914
|
PRIMARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period.Population: All participants enrolled into Part A and Part B who received 900mg plixorafenib.
Time at which the maximum concentration was observed, obtained by inspection.
Outcome measures
| Measure |
Treatment D
n=12 Participants
Treatment D: 900 mg plixorafenib administered with 150 mg cobicistat following a low-fat meal (fed state-low-fat meal).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment 1
n=12 Participants
Treatment 1: 900 mg plixorafenib (6 × 150 mg tablets) administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
|
Treatment 2
n=12 Participants
Treatment 2: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment 3
n=12 Participants
Treatment 3: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered following a high fat, high caloric meal (fed state).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment A
n=12 Participants
Treatment A: 900 mg plixorafenib administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
|
Treatment B
n=12 Participants
Treatment B: 900 mg plixorafenib administered following a high-fat high caloric meal (fed state-high fat meal).
Plixorafenib: Oral Tablet
|
Treatment C
n=12 Participants
Treatment C: 900 mg plixorafenib administered following a low-fat meal (fed state-low-fat meal).
Plixorafenib: Oral Tablet
|
|---|---|---|---|---|---|---|---|
|
Time to Maximum Observed Plasma Concentration (Tmax).
|
3.679 h
Standard Deviation 0.6283
|
2.668 h
Standard Deviation 0.7772
|
3.3 h
Standard Deviation 0.87
|
6.2 h
Standard Deviation 1.8
|
2.935 h
Standard Deviation 1.3348
|
2.676 h
Standard Deviation 0.7972
|
3.443 h
Standard Deviation 1.0918
|
PRIMARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period.Population: All participants enrolled into Part A and Part B who received 900mg plixorafenib. Treatment 1 had an adjusted correlation coefficient (R2) \< 0.75 and the value was excluded from summary statistics.
Terminal rate constant calculated from the terminal slope of the natural log-linear regression of concentration with time.
Outcome measures
| Measure |
Treatment D
n=12 Participants
Treatment D: 900 mg plixorafenib administered with 150 mg cobicistat following a low-fat meal (fed state-low-fat meal).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment 1
n=11 Participants
Treatment 1: 900 mg plixorafenib (6 × 150 mg tablets) administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
|
Treatment 2
n=12 Participants
Treatment 2: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment 3
n=12 Participants
Treatment 3: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered following a high fat, high caloric meal (fed state).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment A
n=12 Participants
Treatment A: 900 mg plixorafenib administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
|
Treatment B
n=12 Participants
Treatment B: 900 mg plixorafenib administered following a high-fat high caloric meal (fed state-high fat meal).
Plixorafenib: Oral Tablet
|
Treatment C
n=12 Participants
Treatment C: 900 mg plixorafenib administered following a low-fat meal (fed state-low-fat meal).
Plixorafenib: Oral Tablet
|
|---|---|---|---|---|---|---|---|
|
Terminal Elimination Rate Constant (λz).
|
0.05538 1/h
Standard Deviation 0.02338
|
0.05129 1/h
Standard Deviation 0.020593
|
0.06208 1/h
Standard Deviation 0.036737
|
0.06057 1/h
Standard Deviation 0.024043
|
0.04381 1/h
Standard Deviation 0.031688
|
0.04046 1/h
Standard Deviation 0.019789
|
0.05121 1/h
Standard Deviation 0.020887
|
PRIMARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period.Population: All participants enrolled into Part A and Part B who received 900mg plixorafenib. Treatment 1 had an adjusted correlation coefficient (R2) \< 0.75 and the value was excluded from summary statistics.
Terminal half-life, calculated as ln (2)/λz.
Outcome measures
| Measure |
Treatment D
n=12 Participants
Treatment D: 900 mg plixorafenib administered with 150 mg cobicistat following a low-fat meal (fed state-low-fat meal).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment 1
n=11 Participants
Treatment 1: 900 mg plixorafenib (6 × 150 mg tablets) administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
|
Treatment 2
n=12 Participants
Treatment 2: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment 3
n=12 Participants
Treatment 3: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered following a high fat, high caloric meal (fed state).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment A
n=12 Participants
Treatment A: 900 mg plixorafenib administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
|
Treatment B
n=12 Participants
Treatment B: 900 mg plixorafenib administered following a high-fat high caloric meal (fed state-high fat meal).
Plixorafenib: Oral Tablet
|
Treatment C
n=12 Participants
Treatment C: 900 mg plixorafenib administered following a low-fat meal (fed state-low-fat meal).
Plixorafenib: Oral Tablet
|
|---|---|---|---|---|---|---|---|
|
Terminal Phase Half-life (t1/2).
|
16.868 h
Standard Deviation 11.8901
|
15.603 h
Standard Deviation 6.1525
|
21.036 h
Standard Deviation 23.4608
|
14.285 h
Standard Deviation 9.4796
|
23.976 h
Standard Deviation 17.1641
|
22.909 h
Standard Deviation 14.0374
|
17.009 h
Standard Deviation 10.3003
|
PRIMARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period.Population: All participants enrolled into Part A and Part B who received 900mg plixorafenib. Treatment 1 had an adjusted correlation coefficient (R2) \< 0.75 and the value was excluded from summary statistics.
Oral clearance, calculated as Dose/AUC0 inf.
Outcome measures
| Measure |
Treatment D
n=12 Participants
Treatment D: 900 mg plixorafenib administered with 150 mg cobicistat following a low-fat meal (fed state-low-fat meal).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment 1
n=11 Participants
Treatment 1: 900 mg plixorafenib (6 × 150 mg tablets) administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
|
Treatment 2
n=12 Participants
Treatment 2: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment 3
n=12 Participants
Treatment 3: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered following a high fat, high caloric meal (fed state).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment A
n=12 Participants
Treatment A: 900 mg plixorafenib administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
|
Treatment B
n=12 Participants
Treatment B: 900 mg plixorafenib administered following a high-fat high caloric meal (fed state-high fat meal).
Plixorafenib: Oral Tablet
|
Treatment C
n=12 Participants
Treatment C: 900 mg plixorafenib administered following a low-fat meal (fed state-low-fat meal).
Plixorafenib: Oral Tablet
|
|---|---|---|---|---|---|---|---|
|
Apparent Oral Clearance (CL/F).
|
2.123 L/h
Standard Deviation 0.8305
|
25.521 L/h
Standard Deviation 14.6921
|
7.211 L/h
Standard Deviation 4.166
|
1.837 L/h
Standard Deviation 0.4374
|
15.868 L/h
Standard Deviation 7.5778
|
8.301 L/h
Standard Deviation 2.8639
|
5.628 L/h
Standard Deviation 1.402
|
PRIMARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period.Population: All participants enrolled into Part A and Part B who received 900mg plixorafenib. Treatment 1 had an adjusted correlation coefficient (R2) \< 0.75 and the value was excluded from summary statistics.
Outcome measures
| Measure |
Treatment D
n=12 Participants
Treatment D: 900 mg plixorafenib administered with 150 mg cobicistat following a low-fat meal (fed state-low-fat meal).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment 1
n=11 Participants
Treatment 1: 900 mg plixorafenib (6 × 150 mg tablets) administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
|
Treatment 2
n=12 Participants
Treatment 2: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment 3
n=12 Participants
Treatment 3: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered following a high fat, high caloric meal (fed state).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment A
n=12 Participants
Treatment A: 900 mg plixorafenib administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
|
Treatment B
n=12 Participants
Treatment B: 900 mg plixorafenib administered following a high-fat high caloric meal (fed state-high fat meal).
Plixorafenib: Oral Tablet
|
Treatment C
n=12 Participants
Treatment C: 900 mg plixorafenib administered following a low-fat meal (fed state-low-fat meal).
Plixorafenib: Oral Tablet
|
|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F).
|
45.258 L
Standard Deviation 23.8247
|
631.925 L
Standard Deviation 519.1238
|
208.855 L
Standard Deviation 307.5796
|
36.971 L
Standard Deviation 22.4434
|
442.143 L
Standard Deviation 222.1673
|
237.592 L
Standard Deviation 87.5592
|
124.526 L
Standard Deviation 53.1671
|
PRIMARY outcome
Timeframe: Predose (0 hours) and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 32, 48, 72, and 96 hours after dosing in each treatment period.Population: All participants enrolled into Part A and Part B who received 900mg plixorafenib.
Outcome measures
| Measure |
Treatment D
n=12 Participants
Treatment D: 900 mg plixorafenib administered with 150 mg cobicistat following a low-fat meal (fed state-low-fat meal).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment 1
n=12 Participants
Treatment 1: 900 mg plixorafenib (6 × 150 mg tablets) administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
|
Treatment 2
n=12 Participants
Treatment 2: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment 3
n=12 Participants
Treatment 3: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered following a high fat, high caloric meal (fed state).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment A
n=12 Participants
Treatment A: 900 mg plixorafenib administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
|
Treatment B
n=12 Participants
Treatment B: 900 mg plixorafenib administered following a high-fat high caloric meal (fed state-high fat meal).
Plixorafenib: Oral Tablet
|
Treatment C
n=12 Participants
Treatment C: 900 mg plixorafenib administered following a low-fat meal (fed state-low-fat meal).
Plixorafenib: Oral Tablet
|
|---|---|---|---|---|---|---|---|
|
Lag Time of Absorption or the Time Delay Between Time 0 and the First Observed Quantifiable Concentration, Obtained by Inspection.
|
0 h
Standard Deviation 0
|
0 h
Standard Deviation 0
|
0 h
Standard Deviation 0
|
0 h
Standard Deviation 0
|
0 h
Standard Deviation 0
|
0 h
Standard Deviation 0
|
0 h
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Predose (0 hours) and at intervals 0-4, 4-8, 8-12, 12-24 and 24-48 hours after dosing in each treatment period.Population: All participants enrolled into Part A only who received 900mg plixorafenib.
The cumulative amount of plixorafenib in urine from 0 to 48 hours, Ae,48, was calculated for the Part A participants only as the sum between 0 and 48 hours of the product of the urine concentration and the urine volume for each collection interval by participant for each treatment.
Outcome measures
| Measure |
Treatment D
Treatment D: 900 mg plixorafenib administered with 150 mg cobicistat following a low-fat meal (fed state-low-fat meal).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment 1
n=12 Participants
Treatment 1: 900 mg plixorafenib (6 × 150 mg tablets) administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
|
Treatment 2
n=12 Participants
Treatment 2: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment 3
n=12 Participants
Treatment 3: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered following a high fat, high caloric meal (fed state).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment A
Treatment A: 900 mg plixorafenib administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
|
Treatment B
Treatment B: 900 mg plixorafenib administered following a high-fat high caloric meal (fed state-high fat meal).
Plixorafenib: Oral Tablet
|
Treatment C
Treatment C: 900 mg plixorafenib administered following a low-fat meal (fed state-low-fat meal).
Plixorafenib: Oral Tablet
|
|---|---|---|---|---|---|---|---|
|
Cumulative Amount of Plixorafenib Excreted in Urine(Ae)
|
—
|
0.11749 mg
Standard Deviation 0.057749
|
0.46969 mg
Standard Deviation 0.229764
|
1.82134 mg
Standard Deviation 0.865302
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose (0 hours) and at intervals 0-4, 4-8, 8-12, 12-24 and 24-48 hours after dosing in each treatment period.Population: All participants enrolled into Part A only who received 900mg plixorafenib.
The percent of the dose excreted in urine in 48 hours (fe,48%) was calculated as Ae,48\*100/Dose.
Outcome measures
| Measure |
Treatment D
Treatment D: 900 mg plixorafenib administered with 150 mg cobicistat following a low-fat meal (fed state-low-fat meal).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment 1
n=12 Participants
Treatment 1: 900 mg plixorafenib (6 × 150 mg tablets) administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
|
Treatment 2
n=12 Participants
Treatment 2: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment 3
n=12 Participants
Treatment 3: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered following a high fat, high caloric meal (fed state).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment A
Treatment A: 900 mg plixorafenib administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
|
Treatment B
Treatment B: 900 mg plixorafenib administered following a high-fat high caloric meal (fed state-high fat meal).
Plixorafenib: Oral Tablet
|
Treatment C
Treatment C: 900 mg plixorafenib administered following a low-fat meal (fed state-low-fat meal).
Plixorafenib: Oral Tablet
|
|---|---|---|---|---|---|---|---|
|
Percent of Dose Excreted in Urine in 48 Hours.
|
—
|
0.01305 percent
Standard Deviation 0.006417
|
0.05219 percent
Standard Deviation 0.025529
|
0.20237 percent
Standard Deviation 0.096145
|
—
|
—
|
—
|
Adverse Events
Treatment 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Treatment A
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment B
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Treatment C
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Treatment D
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 |
Treatment 1
n=12 participants at risk
Treatment 1: 900 mg plixorafenib (6 × 150 mg tablets) administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
|
Treatment 2
n=12 participants at risk
Treatment 2: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment 3
n=12 participants at risk
Treatment 3: 900 mg plixorafenib (6 × 150 mg tablets) + cobicistat (1 × 150 mg tablet) administered following a high fat, high caloric meal (fed state).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
Treatment A
n=12 participants at risk
Treatment A: 900 mg plixorafenib administered after overnight fast (fasted state).
Plixorafenib: Oral Tablet
|
Treatment B
n=12 participants at risk
Treatment B: 900 mg plixorafenib administered following a high-fat high caloric meal (fed state-high fat meal).
Plixorafenib: Oral Tablet
|
Treatment C
n=12 participants at risk
Treatment C: 900 mg plixorafenib administered following a low-fat meal (fed state-low-fat meal).
Plixorafenib: Oral Tablet
|
Treatment D
n=12 participants at risk
Treatment D: 900 mg plixorafenib administered with 150 mg cobicistat following a low-fat meal (fed state-low-fat meal).
Plixorafenib: Oral Tablet
Cobicistat: Oral Tablet
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Number of events 1 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
8.3%
1/12 • Number of events 1 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
8.3%
1/12 • Number of events 1 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
8.3%
1/12 • Number of events 1 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
8.3%
1/12 • Number of events 1 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
16.7%
2/12 • Number of events 2 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
8.3%
1/12 • Number of events 1 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
8.3%
1/12 • Number of events 1 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
8.3%
1/12 • Number of events 1 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
|
General disorders
Medical device site dermatitis
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
8.3%
1/12 • Number of events 1 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
8.3%
1/12 • Number of events 1 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
8.3%
1/12 • Number of events 1 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
8.3%
1/12 • Number of events 1 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
8.3%
1/12 • Number of events 1 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
8.3%
1/12 • Number of events 1 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
8.3%
1/12 • Number of events 1 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
8.3%
1/12 • Number of events 1 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
8.3%
1/12 • Number of events 1 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
8.3%
1/12 • Number of events 1 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
8.3%
1/12 • Number of events 1 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
8.3%
1/12 • Number of events 1 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
8.3%
1/12 • Number of events 1 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
0.00%
0/12 • Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
Patients were monitored on a daily basis for changes in vital signs, collection of adverse events and clinical labs for the duration of 20 days for Part A and Part B each.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place