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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00928083
The ClinicalTrials.gov registry entry for NCT00928083 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medicines for Malaria Venture, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which OZ439 50mg API capsules is the first listed.
NCT00928083 reports 0 study locations.
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.
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