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NCT00928083 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of OZ439 in Healthy Male and Female Subjects
A Phase 1 study, sponsored by Medicines for Malaria Venture.
- Completed
- Registry status
- Phase 1
- Development phase
- 63
- Enrollment target
NCT00928083: Completed Phase 1 study, sponsored by Medicines for Malaria Venture.
NCT00928083 is a Phase 1 study that has completed, run by Medicines for Malaria Venture. The registered enrollment target is 63 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00928083, a Phase 1 study, has completed, sponsored by Medicines for Malaria Venture.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 63 participants
- Enrollment target
Study Summary
OZ439 is a synthetic trioxolane that has potential value as a peroxide antimalarial agent. This was a Phase I, single-centre, multi-component, double-blind, randomised, placebo-controlled study in healthy male and female subjects. The study was conducted in 3 parts: * Part A investigated the safety, tolerability and pharmacokinetics (PK) of single oral escalating doses of OZ439. Up to 6 dose levels will be investigated to estimate dose proportionality. * Part B, the effect of food on a single oral dose of OZ439 was investigated in a 2-way crossover design. * Part C investigated the safety, tolerability and PK profile of multiple oral doses of OZ439. The starting oral dose was 50 mg and the maximum single dose to be administered did not exceed 1600 mg per subject. The maximum duration of dosing proposed was 3 days.
Primary Outcome
Safety/Tolerability evaluation took into account the recorded AE profile, clinical laboratory safety tests, vital signs, 12 lead and continuous (Parts A and C) ECG monitoring, audiometry/Brainstem Auditory Evoked Potentials (BAEP) parameters (Parts A and C) including any additional tests required to evaluate any safety concerns.
Interventions
- DRUG OZ439 50mg API capsules
- DRUG OZ439 200mg API capsules
- DRUG OZ439 400mg aqueous dispersion
- DRUG OZ439 800mg aqueous dispersion
- DRUG OZ439 100mg API capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2009-04 |
| Est. Completion | 2009-12 |
| Phase | Phase 1 |
What the finished NCT00928083 record still lists
NCT00928083 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which OZ439 50mg API capsules is the first listed.
NCT00928083 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00928083 about?
NCT00928083 is a clinical study titled "A Study to Investigate the Safety, Tolerability and Pharmacokinetics of OZ439 in Healthy Male and Female Subjects". OZ439 is a synthetic trioxolane that has potential value as a peroxide antimalarial agent. This was a Phase I, single-centre, multi-component, double-blind, randomised, placebo-controlled study in healthy male and female subjects. The study was conducted in 3 parts: * Part A investigated the safet...
What is the current status of trial NCT00928083?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 63 participants. The study started on 2009-04. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00928083?
The interventions under investigation include: OZ439 50mg API capsules (DRUG), OZ439 200mg API capsules (DRUG), OZ439 400mg aqueous dispersion (DRUG), OZ439 800mg aqueous dispersion (DRUG), OZ439 100mg API capsules (DRUG).
Who is sponsoring clinical trial NCT00928083?
This trial is sponsored by Medicines for Malaria Venture, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00928083's enrollment target sits among peer trials
63 820th of 2000 higher than 1,177 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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