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NCT00741468 · ClinicalTrials.gov registry record · Phase 1
Open-Label, Multiple-Dose, Non-Randomized Study to Assess Drug-Drug Interactions of Proellex® in Female Subjects
A Phase 1 study of Drug Interactions, sponsored by Repros Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT00741468: Completed Phase 1 study of Drug Interactions, sponsored by Repros Therapeutics.
NCT00741468 is a Phase 1 study of Drug Interactions that has completed, run by Repros Therapeutics. The registered enrollment target is 18 participants, below the 727-participant average among 6 other Drug Interactions trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00741468, a Phase 1 study of Drug Interactions, has completed, sponsored by Repros Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will assess possible drug-drug interactions with specific isoenzymes over a total study duration of 6-8 weeks. Blood samples collected pre and post-dose, and urine samples collected post dose will be analyzed.
Primary Outcome
Assessment of the drug-drug interactions of Proellex® (CDB-4124) with cytochrome P450 isoenzymes CYP1A2, 2C9, 2C19, 2D6, and 3A4 in healthy female subjects administered 50 mg Proellex® once daily (QD). The Day 8 AUC was compared to the Day 1 AUC to determine inhibition. For CYP1A2 the plasma paraxanthine/caffeine MR ratio (metabolic ratio) was used. For CYP2D6 the MR ratio of dextromethorphan/dextrorphan was used.
Conditions Studied
Interventions
- DRUG Proellex
- DRUG CYP1A2 probe
- DRUG CYP2C9 probe
- DRUG CYP2C19 probe
- DRUG CYP2D6 probe
Study Locations (1)
New Jersey
- Clinical Research Center Advanced Biomedical Research Inc. - Hackensack
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2008-07 |
| Est. Completion | 2008-10 |
| Phase | Phase 1 |
What the finished NCT00741468 record still lists
NCT00741468 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 727-participant average among 6 other Drug Interactions trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Drug Interactions appearing as the primary indexed condition, and to 5 interventions - of which Proellex is the first listed.
NCT00741468 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT00741468 about?
NCT00741468 is a clinical study titled "Open-Label, Multiple-Dose, Non-Randomized Study to Assess Drug-Drug Interactions of Proellex® in Female Subjects". This study will assess possible drug-drug interactions with specific isoenzymes over a total study duration of 6-8 weeks. Blood samples collected pre and post-dose, and urine samples collected post dose will be analyzed.
What is the current status of trial NCT00741468?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2008-07. Estimated completion is 2008-10.
What conditions does trial NCT00741468 study?
This clinical trial studies the following conditions: Drug Interactions.
What interventions are being tested in trial NCT00741468?
The interventions under investigation include: Proellex (DRUG), CYP1A2 probe (DRUG), CYP2C9 probe (DRUG), CYP2C19 probe (DRUG), CYP2D6 probe (DRUG).
Who is sponsoring clinical trial NCT00741468?
This trial is sponsored by Repros Therapeutics, which has 50 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00741468 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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