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A Dose-escalation Study to Investigate Safety and Toleration of OZ439

NCT01713608 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2015-03-23

Study results available
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Summary

A randomised, placebo-controlled, dose-escalation study to investigate safety and toleration of OZ439 OD for 3 days to healthy male and female volunteers. The study aims:

* To determine the safety and tolerability of ascending doses of OZ439 OD for three days.
* To assess pharmacokinetic parameters of ascending doses of OZ439 given OD.
* To identify the maximum tolerated dose of OZ439 administered.

Conditions

Interventions

DRUG

OZ439

OZ439 x mg once daily for 3 days with milk

Sponsors & Collaborators

  • Medicines for Malaria Venture

    lead OTHER

Principal Investigators

  • Fiona Macintyre, PhD · Medicines for Malaria Venture

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United Kingdom

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 NCT01713608 on ClinicalTrials.gov