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Phase I Study of Ascending Doses of MMV390048 in Healthy Adult Volunteers

NCT02230579 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2019-07-17

Study results available
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Summary

This is a first-in-human study of MMV390048. The study will evaluate the safety, tolerability and pharmacokinetic properties of escalating single and multiple doses of MMV390048 when administered to healthy male volunteers and female volunteers of non-childbearing potential.

In addition, the effect of food on the pharmacokinetics and tolerability of MMV390048 will be investigated.

Conditions

Interventions

DRUG

MMV390048 5mg

Supplied as "powder in bottle" formulation for reconstitution pre-dose

DRUG

MMV390048 20mg

Supplied as "powder in bottle" formulation for reconstitution pre-dose.

DRUG

MMV390048 40mg

Supplied as "powder in bottle" formulation for reconstitution pre-dose

DRUG

MMV390048 80mg

Supplied as "powder in bottle" formulation for reconstitution pre-dose

DRUG

MMV390048 120mg

Supplied as "powder in bottle" formulation for reconstitution pre-dose

DRUG

Placebo to match MMV390048

Supplied as "powder in bottle" formulation for reconstitution pre-dose

Sponsors & Collaborators

  • University of Cape Town

    collaborator OTHER

  • Medicines for Malaria Venture

    lead OTHER

Principal Investigators

  • Karen Barnes, Prof · University of Cape Town

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02230579 on ClinicalTrials.gov