Trial Outcomes & Findings for Bioavailability Study of Oral OZ439 Prototype Granule Formulations Administered With Piperaquine Phosphate (PQP) Tablets (NCT NCT02387580)
NCT ID: NCT02387580
Last Updated: 2016-02-08
Results Overview
OZ439 Maximum observed concentration
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours post-dose
Results posted on
2016-02-08
Participant Flow
Participant milestones
| Measure |
Regimen A: OZ439 + TPGS and PQP
800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen B: OZ439 Prototype 1 and PQP - 110mL
800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen C: OZ439 Prototype 3 and PQP - 110mL
800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen D: OZ439 + TPGS and PQP
800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL
800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL
800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
7
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Regimen A: OZ439 + TPGS and PQP
800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen B: OZ439 Prototype 1 and PQP - 110mL
800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen C: OZ439 Prototype 3 and PQP - 110mL
800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen D: OZ439 + TPGS and PQP
800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL
800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL
800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Bioavailability Study of Oral OZ439 Prototype Granule Formulations Administered With Piperaquine Phosphate (PQP) Tablets
Baseline characteristics by cohort
| Measure |
Regimen A: OZ439 + TPGS and PQP
n=8 Participants
800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen B: OZ439 Prototype 1 and PQP - 110mL
n=8 Participants
800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen C: OZ439 Prototype 3 and PQP - 110mL
n=8 Participants
800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen D: OZ439 + TPGS and PQP
n=8 Participants
800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL
n=8 Participants
800 mg OZ439 Prototype 1 or 3 granules (120 mL oral suspension and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL
n=8 Participants
800 mg OZ439 Prototype 1 or 3 granules (120 mL oral suspension and 100 mL rinse volume ) and 960 mg (3 × 320 mg) PQP tablets
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
30 years
STANDARD_DEVIATION 8.9 • n=93 Participants
|
34.5 years
STANDARD_DEVIATION 12.7 • n=4 Participants
|
34.9 years
STANDARD_DEVIATION 9.8 • n=27 Participants
|
32.0 years
STANDARD_DEVIATION 12.9 • n=483 Participants
|
31.3 years
STANDARD_DEVIATION 12.9 • n=36 Participants
|
30.1 years
STANDARD_DEVIATION 7.0 • n=10 Participants
|
32.1 years
STANDARD_DEVIATION 10.5 • n=115 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
8 Participants
n=10 Participants
|
47 Participants
n=115 Participants
|
|
Region of Enrollment
United Kingdom
|
8 participants
n=93 Participants
|
8 participants
n=4 Participants
|
8 participants
n=27 Participants
|
8 participants
n=483 Participants
|
8 participants
n=36 Participants
|
8 participants
n=10 Participants
|
48 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours post-dosePopulation: The PK population was to include all valid profiles from subjects dosed with IMP. 45 subjects were included in the PK population. 3 subjects vomited approximately 1 to 2 h after dosing and were excluded.
OZ439 Maximum observed concentration
Outcome measures
| Measure |
Regimen A: OZ439 + TPGS and PQP
n=7 Participants
800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen B: OZ439 Prototype 1 and PQP - 110mL
n=8 Participants
800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen C: OZ439 Prototype 3 and PQP - 110mL
n=8 Participants
800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen D: OZ439 + TPGS and PQP
n=6 Participants
800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL
n=8 Participants
800 mg OZ439 Prototype 1 or 3 granules (120 mL oral suspension and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL
n=8 Participants
800 mg OZ439 Prototype 1 or 3 granules (120 mL oral suspension and 100 mL rinse volume ) and 960 mg (3 × 320 mg) PQP tablets
|
|---|---|---|---|---|---|---|
|
OZ439 Cmax
|
1600 ng/mL
Geometric Coefficient of Variation 36.6
|
824 ng/mL
Geometric Coefficient of Variation 38.3
|
616 ng/mL
Geometric Coefficient of Variation 49.4
|
1530 ng/mL
Geometric Coefficient of Variation 13.2
|
999 ng/mL
Geometric Coefficient of Variation 40.8
|
730 ng/mL
Geometric Coefficient of Variation 35.7
|
PRIMARY outcome
Timeframe: pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours post-dosePopulation: The PK population was to include all valid profiles from subjects dosed with IMP. 45 subjects were included in the PK population. 3 subjects vomited approximately 1 to 2 h after dosing and were excluded.
OZ439 Area under the plasma concentration (AUC) versus time curve
Outcome measures
| Measure |
Regimen A: OZ439 + TPGS and PQP
n=7 Participants
800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen B: OZ439 Prototype 1 and PQP - 110mL
n=8 Participants
800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen C: OZ439 Prototype 3 and PQP - 110mL
n=8 Participants
800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen D: OZ439 + TPGS and PQP
n=6 Participants
800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL
n=8 Participants
800 mg OZ439 Prototype 1 or 3 granules (120 mL oral suspension and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL
n=8 Participants
800 mg OZ439 Prototype 1 or 3 granules (120 mL oral suspension and 100 mL rinse volume ) and 960 mg (3 × 320 mg) PQP tablets
|
|---|---|---|---|---|---|---|
|
OZ439 AUC(0-168 h)
|
15300 ng*h/mL
Geometric Coefficient of Variation 26.1
|
7920 ng*h/mL
Geometric Coefficient of Variation 26.4
|
5610 ng*h/mL
Geometric Coefficient of Variation 38.1
|
14000 ng*h/mL
Geometric Coefficient of Variation 29.6
|
9550 ng*h/mL
Geometric Coefficient of Variation 57.5
|
7100 ng*h/mL
Geometric Coefficient of Variation 45.7
|
PRIMARY outcome
Timeframe: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours and Day36 post-dosePopulation: The PK population was to include all valid profiles from subjects dosed with IMP. 45 subjects were included in the PK population. 3 subjects vomited approximately 1 to 2 h after dosing and were excluded.
Piperaquine Maximum observed concentration
Outcome measures
| Measure |
Regimen A: OZ439 + TPGS and PQP
n=7 Participants
800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen B: OZ439 Prototype 1 and PQP - 110mL
n=8 Participants
800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen C: OZ439 Prototype 3 and PQP - 110mL
n=8 Participants
800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen D: OZ439 + TPGS and PQP
n=6 Participants
800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL
n=8 Participants
800 mg OZ439 Prototype 1 or 3 granules (120 mL oral suspension and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL
n=8 Participants
800 mg OZ439 Prototype 1 or 3 granules (120 mL oral suspension and 100 mL rinse volume ) and 960 mg (3 × 320 mg) PQP tablets
|
|---|---|---|---|---|---|---|
|
Piperaquine Cmax
|
183 ng/mL
Geometric Coefficient of Variation 124.9
|
62.1 ng/mL
Geometric Coefficient of Variation 154.4
|
100 ng/mL
Geometric Coefficient of Variation 80.7
|
119 ng/mL
Geometric Coefficient of Variation 52.1
|
91.8 ng/mL
Geometric Coefficient of Variation 108.2
|
95.7 ng/mL
Geometric Coefficient of Variation 81.5
|
PRIMARY outcome
Timeframe: Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 48, 72, 96 and 168 hours and Day36 post-dosePopulation: The PK population was to include all valid profiles from subjects dosed with IMP. 45 subjects were included in the PK population. 3 subjects vomited approximately 1 to 2 h after dosing and were excluded.
PQP Area under the plasma concentration versus time curve
Outcome measures
| Measure |
Regimen A: OZ439 + TPGS and PQP
n=7 Participants
800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen B: OZ439 Prototype 1 and PQP - 110mL
n=8 Participants
800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen C: OZ439 Prototype 3 and PQP - 110mL
n=8 Participants
800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen D: OZ439 + TPGS and PQP
n=6 Participants
800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL
n=8 Participants
800 mg OZ439 Prototype 1 or 3 granules (120 mL oral suspension and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL
n=8 Participants
800 mg OZ439 Prototype 1 or 3 granules (120 mL oral suspension and 100 mL rinse volume ) and 960 mg (3 × 320 mg) PQP tablets
|
|---|---|---|---|---|---|---|
|
Piperaquine AUC(0-168 h)
|
3740 ng*h/mL
Geometric Coefficient of Variation 61.2
|
1940 ng*h/mL
Geometric Coefficient of Variation 69.5
|
2980 ng*h/mL
Geometric Coefficient of Variation 47.6
|
2860 ng*h/mL
Geometric Coefficient of Variation 40.2
|
2550 ng*h/mL
Geometric Coefficient of Variation 47.8
|
2470 ng*h/mL
Geometric Coefficient of Variation 60.8
|
Adverse Events
Regimen A: OZ439 + TPGS and PQP
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Regimen B: OZ439 Prototype 1 and PQP - 110mL
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Regimen C: OZ439 Prototype 3 and PQP - 110mL
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Regimen D: OZ439 + TPGS and PQP
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Regimen A: OZ439 + TPGS and PQP
n=8 participants at risk
800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen B: OZ439 Prototype 1 and PQP - 110mL
n=8 participants at risk
800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen C: OZ439 Prototype 3 and PQP - 110mL
n=8 participants at risk
800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen D: OZ439 + TPGS and PQP
n=8 participants at risk
800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL
n=8 participants at risk
800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL
n=8 participants at risk
800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
Other adverse events
| Measure |
Regimen A: OZ439 + TPGS and PQP
n=8 participants at risk
800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen B: OZ439 Prototype 1 and PQP - 110mL
n=8 participants at risk
800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen C: OZ439 Prototype 3 and PQP - 110mL
n=8 participants at risk
800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen D: OZ439 + TPGS and PQP
n=8 participants at risk
800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL
n=8 participants at risk
800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL
n=8 participants at risk
800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8 • Number of events 2 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
37.5%
3/8 • Number of events 3 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
25.0%
2/8 • Number of events 2 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
|
Gastrointestinal disorders
Diarrhea
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
25.0%
2/8 • Number of events 2 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
25.0%
2/8 • Number of events 2 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
25.0%
2/8 • Number of events 2 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
25.0%
2/8 • Number of events 2 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
|
Gastrointestinal disorders
Epigastric Discomfort
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
|
Gastrointestinal disorders
Salivary Hypersecretion
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
|
Injury, poisoning and procedural complications
Contusion
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
|
Injury, poisoning and procedural complications
Ligament Injury
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
|
Infections and infestations
Influenza
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
0.00%
0/8 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
12.5%
1/8 • Number of events 1 • Up to Day 36 post-dose.
The safety population was to include all subjects who received at least 1 dose of IMP. All 48 subjects met the criteria for inclusion in the safety population.
|
Additional Information
Fiona Macintyre PhD
Medicines for Malaria Venture (MMV)
Phone: +41 22 555 0319
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Quotient shall have the right to publish the results of the research, subject to the sponsor's prior written consent, which shall not be unreasonably withheld or delayed. Following the receipt of such consent, Quotient shall submit a copy of the proposed publication to the sponsor who shall have 30 days in which to request amendments thereto which, to the extent that such proposed amendments are reasonable, Quotient shall be obliged to incorporate prior to such publication.
- Publication restrictions are in place
Restriction type: OTHER