Trial Outcomes & Findings for Safety, Tolerability and Antimalarial Activity of Single Doses of OZ439 and PQP (NCT NCT03542149)
NCT ID: NCT03542149
Last Updated: 2024-05-10
Results Overview
Maximum observed drug concentration in observed individual concentration-time profile.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
PK data up to Day 28 post-dose
Results posted on
2024-05-10
Participant Flow
Location: phase 1 unit
Participant milestones
| Measure |
Cohort 1: Treatment Group A: 200mg of OZ439 and 480 mg PQP
200mg of OZ439 and 480 mg PQP. (OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
480 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
200 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Cohort 1:Treatment Group B: 200mg of OZ439 and 640 mg PQP
200mg of OZ439 and 640 mg PQP.
(OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
640 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
200 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Cohort 1:Treatment Group C: 400mg of OZ439 and 480 mg PQP
400mg of OZ439 and 480 mg PQP.
(OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
480 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
400 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Cohort 1, Group D and Cohort 3 Group A: :Treatment 400mg of OZ439 and 640 mg PQP
400mg of OZ439 and 640 mg PQP.
(OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
640 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
400 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Cohort 2: Treatment Group A: 800mg of OZ439 and 960 mg PQP
800mg of OZ439 and 480 mg PQP. (OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
960 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
200 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Cohort 2: Treatment Group B: 200mg of OZ439 and 320 mg PQP
200mg of OZ439 and 480 mg PQP. (OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
320 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
200 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Cohort 3: Treatment Group B: 800mg of OZ439 and 640 mg PQP
800mg of OZ439 and 640 mg PQP. (OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
320 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
200 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
2
|
6
|
4
|
4
|
4
|
|
Overall Study
COMPLETED
|
2
|
2
|
2
|
5
|
4
|
3
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability and Antimalarial Activity of Single Doses of OZ439 and PQP
Baseline characteristics by cohort
| Measure |
Cohort 1: Treatment Group A: 200mg of OZ439 and 480 mg PQP
n=2 Participants
200mg of OZ439 and 480 mg PQP. (OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
480 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
200 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Cohort 1:Treatment Group B: 200mg of OZ439 and 640 mg PQP
n=2 Participants
200mg of OZ439 and 640 mg PQP.
(OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
640 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
200 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Cohort 1:Treatment Group C: 400mg of OZ439 and 480 mg PQP
n=2 Participants
400mg of OZ439 and 480 mg PQP.
(OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
480 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
400 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Cohort 1, Group D and Cohort 3 Group A: :Treatment 400mg of OZ439 and 640 mg PQP
n=6 Participants
400mg of OZ439 and 640 mg PQP.
(OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
640 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
400 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Cohort 2: Treatment Group A: 800mg of OZ439 and 960 mg PQP
n=4 Participants
800mg of OZ439 and 480 mg PQP. (OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
960 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
200 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Cohort 2: Treatment Group B: 200mg of OZ439 and 320 mg PQP
n=4 Participants
200mg of OZ439 and 480 mg PQP. (OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
320 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
200 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Cohort 3: Treatment Group B: 800mg of OZ439 and 640 mg PQP
n=4 Participants
800mg of OZ439 and 640 mg PQP. (OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
320 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
200 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
24 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Age, Continuous
|
36.5 years
STANDARD_DEVIATION 7.78 • n=5 Participants
|
23.0 years
STANDARD_DEVIATION 1.41 • n=7 Participants
|
40.5 years
STANDARD_DEVIATION 17.68 • n=5 Participants
|
23.5 years
STANDARD_DEVIATION 4.09 • n=4 Participants
|
21.3 years
STANDARD_DEVIATION 2.22 • n=21 Participants
|
23.8 years
STANDARD_DEVIATION 3.59 • n=10 Participants
|
20.0 years
STANDARD_DEVIATION 1.41 • n=115 Participants
|
25.0 years
STANDARD_DEVIATION 7.93 • n=6 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
12 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
12 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
4 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
19 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
Australia
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
24 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: PK data up to Day 28 post-dosePopulation: all patients who were treated with OZ and PQP
Maximum observed drug concentration in observed individual concentration-time profile.
Outcome measures
| Measure |
Cohort 1:Treatment Group B: 200mg of OZ439 and 640 mg PQP
n=2 Participants
200mg of OZ439 and 640 mg PQP.
(OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
640 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
200 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Cohort 1: Treatment Group A: 200mg of OZ439 and 480 mg PQP
n=2 Participants
200mg of OZ439 and 480 mg PQP. (OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
480 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
200 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Cohort 1:Treatment Group C: 400mg of OZ439 and 480 mg PQP
n=2 Participants
400mg of OZ439 and 480 mg PQP.
(OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
480 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
400 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Cohort 1, Group D and Cohort 3 Group A: :Treatment 400mg of OZ439 and 640 mg PQP
n=6 Participants
400mg of OZ439 and 640 mg PQP.
(OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
640 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
400 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Cohort 2: Treatment Group A: 800mg of OZ439 and 960 mg PQP
n=4 Participants
800mg of OZ439 and 480 mg PQP. (OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
960 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
200 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Cohort 2: Treatment Group B: 200mg of OZ439 and 320 mg PQP
n=4 Participants
200mg of OZ439 and 480 mg PQP. (OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
320 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
200 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Cohort 3: Treatment Group B: 800mg of OZ439 and 640 mg PQP
n=4 Participants
800mg of OZ439 and 640 mg PQP. (OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
320 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
200 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
|---|---|---|---|---|---|---|---|
|
Characterize the PK/PD Relationship Between OZ439 and PQP Plasma Concentrations (Cmax)
Cmax OZ 439
|
0.2582 ng/L
Standard Deviation 0.05869
|
0.4145 ng/L
Standard Deviation 0.1669
|
0.8829 ng/L
Standard Deviation 0.4108
|
0.6835 ng/L
Standard Deviation 0.2292
|
2.135 ng/L
Standard Deviation 0.7359
|
0.3208 ng/L
Standard Deviation 0.5176
|
1.910 ng/L
Standard Deviation 0.3029
|
|
Characterize the PK/PD Relationship Between OZ439 and PQP Plasma Concentrations (Cmax)
Cmax PQP
|
0.1168 ng/L
Standard Deviation 0.03599
|
0.05441 ng/L
Standard Deviation 0.02072
|
0.06458 ng/L
Standard Deviation 0.02871
|
0.1048 ng/L
Standard Deviation 0.1081
|
0.4104 ng/L
Standard Deviation 0.07950
|
0.04609 ng/L
Standard Deviation 0.07520
|
0.1860 ng/L
Standard Deviation 0.1489
|
PRIMARY outcome
Timeframe: From IP administration to 48 hoursPopulation: all participants who were treated with OZ and PQP
Ratio between parasitemia at the onset of drug treatment and 48 hours later. The PRR is defined as the ratio of the number of parasites at time of treatment divided by the number after a given amount of time has elapsed post-treatment. This time period is normally 48 hours as this is the time taken for P. falciparum parasites to pass through their asexual erythrocytic life cycle.
Outcome measures
| Measure |
Cohort 1:Treatment Group B: 200mg of OZ439 and 640 mg PQP
n=2 Participants
200mg of OZ439 and 640 mg PQP.
(OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
640 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
200 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Cohort 1: Treatment Group A: 200mg of OZ439 and 480 mg PQP
n=2 Participants
200mg of OZ439 and 480 mg PQP. (OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
480 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
200 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Cohort 1:Treatment Group C: 400mg of OZ439 and 480 mg PQP
n=2 Participants
400mg of OZ439 and 480 mg PQP.
(OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
480 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
400 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Cohort 1, Group D and Cohort 3 Group A: :Treatment 400mg of OZ439 and 640 mg PQP
n=6 Participants
400mg of OZ439 and 640 mg PQP.
(OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
640 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
400 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Cohort 2: Treatment Group A: 800mg of OZ439 and 960 mg PQP
n=4 Participants
800mg of OZ439 and 480 mg PQP. (OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
960 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
200 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Cohort 2: Treatment Group B: 200mg of OZ439 and 320 mg PQP
n=4 Participants
200mg of OZ439 and 480 mg PQP. (OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
320 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
200 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Cohort 3: Treatment Group B: 800mg of OZ439 and 640 mg PQP
n=4 Participants
800mg of OZ439 and 640 mg PQP. (OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
320 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
200 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
|---|---|---|---|---|---|---|---|
|
Characterize the PK/PD Relationship Between OZ439 and PQP and Blood Stage Asexual Parasitaemia Measured by Parasite Reduction Ratio at 48 Hours (PRR48)
|
219 ratio
Interval 121.0 to 395.0
|
151 ratio
Interval 100.0 to 228.0
|
3777 ratio
Interval 1970.0 to 7243.0
|
5038 ratio
Interval 3340.0 to 7598.0
|
9656 ratio
Interval 5445.0 to 17125.0
|
78 ratio
Interval 57.0 to 109.0
|
3632 ratio
Interval 2289.0 to 5763.0
|
PRIMARY outcome
Timeframe: from IP administration to 108 hoursPopulation: participants
PCt1/2 = Parasite Clearance Half-life;
Outcome measures
| Measure |
Cohort 1:Treatment Group B: 200mg of OZ439 and 640 mg PQP
n=2 Participants
200mg of OZ439 and 640 mg PQP.
(OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
640 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
200 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Cohort 1: Treatment Group A: 200mg of OZ439 and 480 mg PQP
n=2 Participants
200mg of OZ439 and 480 mg PQP. (OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
480 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
200 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Cohort 1:Treatment Group C: 400mg of OZ439 and 480 mg PQP
n=2 Participants
400mg of OZ439 and 480 mg PQP.
(OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
480 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
400 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Cohort 1, Group D and Cohort 3 Group A: :Treatment 400mg of OZ439 and 640 mg PQP
n=6 Participants
400mg of OZ439 and 640 mg PQP.
(OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
640 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
400 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Cohort 2: Treatment Group A: 800mg of OZ439 and 960 mg PQP
n=4 Participants
800mg of OZ439 and 480 mg PQP. (OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
960 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
200 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Cohort 2: Treatment Group B: 200mg of OZ439 and 320 mg PQP
n=4 Participants
200mg of OZ439 and 480 mg PQP. (OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
320 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
200 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
Cohort 3: Treatment Group B: 800mg of OZ439 and 640 mg PQP
n=4 Participants
800mg of OZ439 and 640 mg PQP. (OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
320 mg Piperaquine phosphate (PQP): Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
200 mg OZ 439: OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension)
|
|---|---|---|---|---|---|---|---|
|
Characterize the PK/PD Relationship Between OZ439 and PQP and Blood Stage Asexual Parasitaemia Measured by Parasite Clearance Half-life
|
6.18 hours
Interval 5.57 to 6.93
|
6.63 hours
Interval 6.13 to 7.22
|
4.04 hours
Interval 3.74 to 4.39
|
3.90 hours
Interval 3.72 to 4.1
|
3.63 hours
Interval 3.41 to 3.87
|
7.63 hours
Interval 7.1 to 8.25
|
4.06 hours
Interval 3.84 to 4.3
|
Adverse Events
Cohort 1: Treatment Group A: 200mg of OZ439 and 480 mg PQP
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 1:Treatment Group B: 200mg of OZ439 and 640 mg PQP
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 1:Treatment Group C: 400mg of OZ439 and 480 mg PQP
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 1Treatment Group D and Cohort 3 Treatment Group A : 400mg of OZ439 and 640 mg PQP
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2: Treatment Group A: 800mg of OZ439 and 960 mg PQP
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2: Treatment Group B: 200mg of OZ439 and 320 mg PQP
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3: Treatment Group B: 800mg of OZ439 and 640 mg PQP
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1: Treatment Group A: 200mg of OZ439 and 480 mg PQP
n=2 participants at risk
200mg of OZ439 and 480 mg PQP. (OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
480 mg Piperaquine phosphate: 480 mg Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
200 mg OZ 439: 200 mg OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension
|
Cohort 1:Treatment Group B: 200mg of OZ439 and 640 mg PQP
n=2 participants at risk
200mg of OZ439 and 640 mg PQP.
(OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
640 mg Piperaquine phosphate: 640 mg Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
200 mg OZ 439: 200 mg OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension
|
Cohort 1:Treatment Group C: 400mg of OZ439 and 480 mg PQP
n=2 participants at risk
400mg of OZ439 and 480 mg PQP.
(OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
480 mg Piperaquine phosphate: 480 mg Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
400 mg OZ 439: 400 mg OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension
|
Cohort 1Treatment Group D and Cohort 3 Treatment Group A : 400mg of OZ439 and 640 mg PQP
n=6 participants at risk
400mg of OZ439 and 640 mg PQP.
(OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension) and PQP.
640 mg Piperaquine phosphate: 640 mg Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
400 mg OZ 439: 400 mg OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension
|
Cohort 2: Treatment Group A: 800mg of OZ439 and 960 mg PQP
n=4 participants at risk
800mg of OZ439 and 960 mg PQP.
800 mg OZ 439: 800 mg OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension
960 mg PQP: 960 mg Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
|
Cohort 2: Treatment Group B: 200mg of OZ439 and 320 mg PQP
n=4 participants at risk
200mg of OZ439 and 320 mg PQP.
400 mg OZ 439: 400 mg OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension
320 mg PQP: 320 mg Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
|
Cohort 3: Treatment Group B: 800mg of OZ439 and 640 mg PQP
n=4 participants at risk
800mg of OZ439 and 640 mg PQP
640 mg Piperaquine phosphate: 640 mg Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
800 mg OZ 439: 800 mg OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension
|
|---|---|---|---|---|---|---|---|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
16.7%
1/6 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
50.0%
2/4 • Number of events 2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
50.0%
2/4 • Number of events 2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
|
General disorders
Pyrexia
|
100.0%
2/2 • Number of events 2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
50.0%
1/2 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
33.3%
2/6 • Number of events 2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
50.0%
2/4 • Number of events 2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
|
General disorders
Bruise at vessel puncture site
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
50.0%
1/2 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
50.0%
1/2 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/6 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
50.0%
2/4 • Number of events 2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
|
General disorders
Chills
|
50.0%
1/2 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
16.7%
1/6 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
25.0%
1/4 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
|
General disorders
Feeling hot
|
50.0%
1/2 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/6 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
100.0%
2/2 • Number of events 2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
50.0%
3/6 • Number of events 3 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
75.0%
3/4 • Number of events 3 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
75.0%
3/4 • Number of events 3 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
25.0%
1/4 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
|
Nervous system disorders
Dizziness
|
50.0%
1/2 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/6 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/6 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
25.0%
1/4 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
16.7%
1/6 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
50.0%
1/2 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
100.0%
2/2 • Number of events 2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
16.7%
1/6 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
25.0%
1/4 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
50.0%
2/4 • Number of events 2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
16.7%
1/6 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
50.0%
2/4 • Number of events 2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
25.0%
1/4 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
50.0%
1/2 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
16.7%
1/6 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/6 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
25.0%
1/4 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
50.0%
1/2 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/6 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
100.0%
2/2 • Number of events 2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/6 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
100.0%
4/4 • Number of events 4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
25.0%
1/4 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
50.0%
1/2 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/6 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
|
Investigations
Fall in haemoglobin
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
50.0%
1/2 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/6 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
25.0%
1/4 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
50.0%
2/4 • Number of events 2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
|
Investigations
Fall in lymphocyte count
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
50.0%
1/2 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/6 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
25.0%
1/4 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
|
Investigations
Fall in neutrophil count
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
16.7%
1/6 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
25.0%
1/4 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
|
Investigations
Prolonged QT interval
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/6 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
25.0%
1/4 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/6 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
50.0%
2/4 • Number of events 2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/6 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
25.0%
1/4 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
|
Injury, poisoning and procedural complications
Bruising at vascular access site
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
16.7%
1/6 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/6 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
25.0%
1/4 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/6 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
50.0%
2/4 • Number of events 2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
|
Infections and infestations
Viral infection
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/6 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
25.0%
1/4 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
|
Cardiac disorders
Tachycardia
|
50.0%
1/2 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/6 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
25.0%
1/4 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/2 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/6 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
25.0%
1/4 • Number of events 1 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
0.00%
0/4 • 38 Days: Treatment Emergent Adverse Events were collected from the time of treatment up to the end of the study.
|
Additional Information
Dr. Helen Demarest
Medicines for Malaria Venture (MMV)
Phone: : +41 22 555 03 24
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place