Trial Outcomes & Findings for Safety, Tolerability and Pharmacokinetic Profile of Ascending Oral Doses of MMV390048, Part A (NCT NCT02783820)
NCT ID: NCT02783820
Last Updated: 2020-06-11
Results Overview
Number of observed and self-reported Adverse Events (AE) (unexpected toxicities, adverse events encountered during or after investigational drug administration)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
28 days post administration of a single oral dose of MMV390048 to healthy volunteers
Results posted on
2020-06-11
Participant Flow
Participant milestones
| Measure |
Pooled Placebo
Pooled placebo from all cohorts (2 per cohort = 6)
|
MMV390048 40 mg
MMV390048 40 mg, tablets, single dose
|
MMV390048 80 mg
MMV390048 80 mg, tablets, single dose
|
MMV390048 120 mg
MMV390048 120 mg, tablets, single dose
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability and Pharmacokinetic Profile of Ascending Oral Doses of MMV390048, Part A
Baseline characteristics by cohort
| Measure |
Pooled Placebo
n=6 Participants
Pooled placebo from all cohorts (2 per cohort = 6)
|
MMV390048 40 mg
n=6 Participants
MMV390048 40 mg, tablets, single dose
|
MMV390048 80 mg
n=6 Participants
MMV390048 80 mg, tablets, single dose
|
MMV390048 120 mg
n=6 Participants
MMV390048 120 mg, tablets, single dose
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
33.3 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
24.8 years
STANDARD_DEVIATION 2.5 • n=7 Participants
|
23 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
40.2 years
STANDARD_DEVIATION 13.9 • n=4 Participants
|
30.3 years
STANDARD_DEVIATION 11.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
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
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 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
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Body Mass Index (BMI)
|
24.1 kg/m^2
STANDARD_DEVIATION 2.4 • n=5 Participants
|
23.4 kg/m^2
STANDARD_DEVIATION 1.9 • n=7 Participants
|
24.3 kg/m^2
STANDARD_DEVIATION 3.2 • n=5 Participants
|
25.4 kg/m^2
STANDARD_DEVIATION 3 • n=4 Participants
|
24.3 kg/m^2
STANDARD_DEVIATION 2.6 • n=21 Participants
|
PRIMARY outcome
Timeframe: 28 days post administration of a single oral dose of MMV390048 to healthy volunteersNumber of observed and self-reported Adverse Events (AE) (unexpected toxicities, adverse events encountered during or after investigational drug administration)
Outcome measures
| Measure |
Pooled Placebo
n=6 Participants
Pooled placebo from all cohorts (2 per cohort = 6)
|
MMV390048 40 mg
n=6 Participants
MMV390048 40 mg, tablets, single dose
|
MMV390048 80 mg
n=6 Participants
MMV390048 80 mg, tablets, single dose
|
MMV390048 120 mg
n=6 Participants
MMV390048 120 mg, tablets, single dose
|
|---|---|---|---|---|
|
Safety of MMV390048 - Number of Adverse Events
|
13 Number of adverse events
|
0 Number of adverse events
|
9 Number of adverse events
|
12 Number of adverse events
|
SECONDARY outcome
Timeframe: 28 daysEstimation of the maximum plasma concentration over 28 days post administration of a single dose of MMV390048 using non-compartmental methods
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 daysEstimation of the time to maximum plasma concentration over 28 days post administration of a single dose of MMV390048 using non-compartmental methods
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 daysEstimation of the last quantifiable concentration over 28 days post administration of a single dose of MMV390048 using non-compartmental methods
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 daysEstimation of the area under the plasma concentration time curve over 28 days post administration of a single dose of MMV390048 using non-compartmental methods
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 daysApparent oral clearance (CL/F) over 28 days post administration of a single dose of MMV390048 using non-compartmental methods
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 daysApparent volume of distribution (Vz/F) over 28 days post administration of a single dose of MMV390048 using non-compartmental methods
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 daysTerminal half-life (t½) over 28 days post administration of a single dose of MMV390048 using non-compartmental methods
Outcome measures
Outcome data not reported
Adverse Events
Pooled Placebo
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
MMV390048 40 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MMV390048 80 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
MMV390048 120 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pooled Placebo
n=6 participants at risk
Pooled placebo from all cohorts (2 per cohort = 6)
|
MMV390048 40 mg
n=6 participants at risk
MMV390048 40 mg, tablets, single dose
|
MMV390048 80 mg
n=6 participants at risk
MMV390048 80 mg, tablets, single dose
|
MMV390048 120 mg
n=6 participants at risk
MMV390048 120 mg, tablets, single dose
|
|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
16.7%
1/6 • Number of events 1 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
Other adverse events
| Measure |
Pooled Placebo
n=6 participants at risk
Pooled placebo from all cohorts (2 per cohort = 6)
|
MMV390048 40 mg
n=6 participants at risk
MMV390048 40 mg, tablets, single dose
|
MMV390048 80 mg
n=6 participants at risk
MMV390048 80 mg, tablets, single dose
|
MMV390048 120 mg
n=6 participants at risk
MMV390048 120 mg, tablets, single dose
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Number of events 1 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
16.7%
1/6 • Number of events 1 • Until Day 28
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 2 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
16.7%
1/6 • Number of events 1 • Until Day 28
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 1 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
|
General disorders
Chest discomfort
|
0.00%
0/6 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
16.7%
1/6 • Number of events 1 • Until Day 28
|
|
General disorders
Malaise
|
0.00%
0/6 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
16.7%
1/6 • Number of events 1 • Until Day 28
|
|
General disorders
Medical device site reaction
|
33.3%
2/6 • Number of events 2 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
16.7%
1/6 • Number of events 1 • Until Day 28
|
16.7%
1/6 • Number of events 1 • Until Day 28
|
|
Infections and infestations
Folliculitis
|
0.00%
0/6 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
16.7%
1/6 • Number of events 1 • Until Day 28
|
16.7%
1/6 • Number of events 1 • Until Day 28
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/6 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
16.7%
1/6 • Number of events 1 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • Number of events 1 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
16.7%
1/6 • Number of events 1 • Until Day 28
|
16.7%
1/6 • Number of events 1 • Until Day 28
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
33.3%
2/6 • Number of events 2 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 1 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 2 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
16.7%
1/6 • Number of events 1 • Until Day 28
|
66.7%
4/6 • Number of events 5 • Until Day 28
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/6 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
16.7%
1/6 • Number of events 1 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
|
Renal and urinary disorders
Sterile pyuria
|
16.7%
1/6 • Number of events 1 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.7%
1/6 • Number of events 1 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
|
Surgical and medical procedures
Suture insertion
|
0.00%
0/6 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
16.7%
1/6 • Number of events 1 • Until Day 28
|
0.00%
0/6 • Until Day 28
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60