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

NCT02783820 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-06-11

Study results available
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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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Clinical Network Services (CNS) Pty Ltd

    collaborator INDUSTRY

  • Q-Pharm Pty Limited

    collaborator INDUSTRY

  • QIMR Berghofer Medical Research Institute

    collaborator OTHER

  • Medicines for Malaria Venture

    lead OTHER

Principal Investigators

  • James McCarthy, Prof · Q-Pharm Pty Ltd and QIMR Berghofer Medical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Australia

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 NCT02783820 on ClinicalTrials.gov