At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 34 enrolled
Drug / intervention
OZ439drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Placebo-controlled, Dose-escalation Study to Investigate Safety and Toleration of OZ439 OD for 3 Days to Healthy Male and Female Volunteers
In Brief
A Phase 1 clinical trial evaluating OZ439 for Malaria. Completed, enrolled 34 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 2012
Enrollment StartNov 2012
Primary CompletionFeb 2013
TodayJul 2026
First PostedOct 25, 2012
Enrollment StartNov 1, 2012
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 13.7 years ago
Interventions
OZ439drug
OZ439 x mg once daily for 3 days with milk