NCT02783820

Safety, Tolerability and Pharmacokinetic Profile of Ascending Oral Doses of MMV390048, Part A

A Single Centre, Two-part, Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of Ascending Oral Doses of MMV390048 and Its Antimalarial Activity Against Plasmodium Falciparum in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Medicines for Malaria Venture · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	MMV390048 40 mg
DRUG	Placebo to match MMV390048 40 mg
DRUG	MMV390048 80 mg
DRUG	Placebo to match MMV390048 80 mg
DRUG	MMV390048 120 mg
DRUG	Placebo to match MMV390048 120 mg

Timeline

• Start date: 2016-05-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-05-26
• Last updated: 2020-06-11
• Results posted: 2020-06-11

Locations

1 site across 1 country: Australia