Conditions: Malaria
Keywords: malaria, single ascending dose,
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 24
Healthy volunteers: yes

Brief summary:
This Phase I study will evaluate the safety, tolerability and pharmacokinetic properties of escalating single doses of reformulated MMV390048 when administered to healthy men and women of non-childbearing potential (WNCBP) under fasted conditions (Part A).

Detailed description:
This Phase I study will evaluate the safety, tolerability and pharmacokinetic properties of escalating single doses of reformulated MMV390048 when administered to healthy men and women of non-childbearing potential (WNCBP) under fasted conditions (Part A).

Primary objectives:

• To evaluate the safety and tolerability of single ascending doses of MMV390048 administered orally to healthy subjects (men and WNCBP) under fasted conditions

Secondary objectives:

• To describe the pharmacokinetics of MMV390048 in healthy subjects (men and WNCBP) after single oral dose administration

Arms:
arm 1: MMV390048 40 mg, tablets, single dose arm 2: Placebo to match MMV390048 40 mg, tablets, single dose arm 3: MMV390048 80 mg, tablets, single dose arm 4: Placebo to match MMV390048 80 mg, tablets, single dose arm 5: MMV390048 120 mg, tablets, single dose arm 6: Placebo to match MMV390048 120 mg, tablets, single dose

Interventions: intervention 1: MMV390048 40 mg intervention 2: Placebo to match MMV390048 40 mg intervention 3: MMV390048 80 mg intervention 4: Placebo to match MMV390048 80 mg intervention 5: MMV390048 120 mg intervention 6: Placebo to match MMV390048 120 mg
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None

Protocol document: