Trial Outcomes & Findings for MMV390048 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Participants (NCT NCT02281344)

Last Updated: 2020-06-09

Results Overview

Pharmacokinetic-pharmacodynamic relationship of MMV390048 on clearance of Plasmodium falciparum parasites from the blood in healthy participants following infection with blood stage parasites. The area under the plasma concentration time curve from time zero to the last measured time point.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

6 participants

Primary outcome timeframe

At pre-dose, and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 (D1), 30, 36, 48 (D2), 72 (D3), and 144 hours (D6) and Days 8, 10, 14, 18 and D21.

Results posted on

2020-06-09

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1 MMV390048 20mg Cohort 1 will receive a single, dose of 20mg MMV390048. MMV390048 20mg: Supplied as a powder to be prepared as a suspension for oral use. The study was conducted in one cohort (n=6) using a 20 mg dose of MMV390048 Powder In Bottle (PIB). Dose escalation was planned in a subsequent cohort, but due to the inconsistent pharmacokinetic profiles of the PIB formulation it was decided to reformulate the compound before proceeding with the study.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MMV390048 Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1 MMV390048 20mg n=6 Participants Cohort 1 will receive a single, dose of 20mg MMV390048. MMV390048 20mg: Supplied as a powder to be prepared as a suspension for oral use. The study was conducted in one cohort (n=6) using a 20 mg dose of MMV390048 Powder In Bottle (PIB). Dose escalation was planned in a subsequent cohort, but due to the inconsistent pharmacokinetic profiles of the PIB formulation it was decided to reformulate the compound before proceeding with the study.
Age, Continuous	25.3 years STANDARD_DEVIATION 4.03 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Body Mass Index (BMI)	24.50 kg/m^2 STANDARD_DEVIATION 4.767 • n=5 Participants

PRIMARY outcome

Timeframe: At pre-dose, and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 (D1), 30, 36, 48 (D2), 72 (D3), and 144 hours (D6) and Days 8, 10, 14, 18 and D21.

Outcome measures

Outcome measures
Measure	Cohort 1 MMV390048 20mg n=6 Participants Cohort 1 will receive a single, dose of 20mg MMV390048. MMV390048 20mg: Supplied as a powder to be prepared as a suspension for oral use. The study was conducted in one cohort (n=6) using a 20 mg dose of MMV390048 Powder In Bottle (PIB). Dose escalation was planned in a subsequent cohort, but due to the inconsistent pharmacokinetic profiles of the PIB formulation it was decided to reformulate the compound before proceeding with the study.
MMV390048 Area Under the Plasma Concentration Versus Time Curve (AUClast) up to Day 21 Post-dose	9487 ng*hr/mL Standard Deviation 2444

SECONDARY outcome

Timeframe: From dosing up to Day 21 Post-dose

The clearance of malaria parasitemia by Polymerase Chain Reaction (PCR) measurement.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At pre-dose, and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24 (D1), 30, 36, 48 (D2), 72 (D3), and 144 hours (D6) and Days 8, 10, 14, 18 and D21.

Maximum Plasma Concentration (Cmax) of MMV390048

Outcome measures

Outcome measures
Measure	Cohort 1 MMV390048 20mg n=6 Participants Cohort 1 will receive a single, dose of 20mg MMV390048. MMV390048 20mg: Supplied as a powder to be prepared as a suspension for oral use. The study was conducted in one cohort (n=6) using a 20 mg dose of MMV390048 Powder In Bottle (PIB). Dose escalation was planned in a subsequent cohort, but due to the inconsistent pharmacokinetic profiles of the PIB formulation it was decided to reformulate the compound before proceeding with the study.
MMV390048 Maximum Plasma Concentration (Cmax)	113 ng/mL Standard Deviation 43.8

SECONDARY outcome

Timeframe: From dosing up to Day 21 Post-dose

Time to Maximum Plasma Concentration (Tmax) of MMV390048

Outcome measures

Outcome data not reported

Adverse Events

Cohort 1 MMV390048 20mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cohort 1 MMV390048 20mg n=6 participants at risk Cohort 1 will receive a single, dose of 20mg MMV390048. MMV390048 20mg: Supplied as a powder to be prepared as a suspension for oral use. The study was conducted in one cohort (n=6) using a 20 mg dose of MMV390048 Powder In Bottle (PIB). Dose escalation was planned in a subsequent cohort, but due to the inconsistent pharmacokinetic profiles of the PIB formulation it was decided to reformulate the compound before proceeding with the study.
Gastrointestinal disorders Nausea	16.7% 1/6 • Number of events 1 • up to Day 21 Post-dose
General disorders Chills	16.7% 1/6 • Number of events 2 • up to Day 21 Post-dose
General disorders Hot flush	16.7% 1/6 • Number of events 1 • up to Day 21 Post-dose
General disorders Hyperhidrosis	16.7% 1/6 • Number of events 1 • up to Day 21 Post-dose
General disorders Pyrexia	50.0% 3/6 • Number of events 7 • up to Day 21 Post-dose
Metabolism and nutrition disorders Decreased appetite	33.3% 2/6 • Number of events 2 • up to Day 21 Post-dose
Musculoskeletal and connective tissue disorders Back pain	16.7% 1/6 • Number of events 1 • up to Day 21 Post-dose
Nervous system disorders Headache	50.0% 3/6 • Number of events 6 • up to Day 21 Post-dose
Nervous system disorders Paraesthesia	16.7% 1/6 • Number of events 1 • up to Day 21 Post-dose
Respiratory, thoracic and mediastinal disorders Rinorrhea	16.7% 1/6 • Number of events 1 • up to Day 21 Post-dose

Additional Information

Dr Cristina Donini

Medicines for Malaria Venture

Phone: +41 22 555 0312

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place