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

2016-05-27 13:08:22 | BioPortfolio

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).

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Malaria

Intervention

MMV390048 40 mg, Placebo to match MMV390048 40 mg, MMV390048 80 mg, Placebo to match MMV390048 80 mg, MMV390048 120 mg, Placebo to match MMV390048 120 mg

Location

Q Pharm Clinics
Herston
Australia
QLD 4006

Status

Recruiting

Source

Medicines for Malaria Venture

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-05-27T13:08:22-0400

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