Open-Label, Multiple-Dose, Non-Randomized Study to Assess Drug-Drug Interactions of Proellex® in Female Subjects
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Drug Interactions |
Drug: Proellex® |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label, Multiple-Dose, Non-Randomized Study to Assess the Drug-Drug Interactions of Proellex® (CDB-4124) With Cytochrome P450 Isoenzymes CYP1A2, 2C9, 2C19, 2D6, and 3A4 in Healthy Female Subjects |
- 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). [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
- Determine the safety and tolerability of Proellex® in healthy female subjects administered 50 mg QD. [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 18 |
| Study Start Date: | July 2008 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
Proellex 50 mg
|
Drug: Proellex®
2, 25 mg Proellex capsules administered daily
|
Detailed Description:
This is an open-label, multiple-dose, non-randomized study to assess the drug-drug interactions of Proellex® with cytochrome P450 isoenzymes in healthy female subjects. On Day 1, following an overnight fast and morning void of the bladder, subjects will be administered CYP probe drugs orally. Serial blood samples will be collected at pre-dose and post-dose. Subjects will be administered two Proellex® 25 mg capsules (50 mg total dose) at approximately 0800 hours on Day 2 and 0700 hours on Days 3 through 8. One hour after administration of Proellex® on Day 8, the five CYP probe drugs will be administered and blood and urine samples collected as on Day 1. Blood samples for the determination of plasma concentrations of CDB-4124 and its metabolite CDB-4453 will be collected at pre-dose (trough) on Days 6, 7, and 8 to determine if steady-state conditions have been achieved. Samples will also be collected on Day 8 at 1, 2, 8 and 24 hour after administration of Proellex® to determine the plasma concentrations of CDB-4124 and CDB-4453.
Eligibility| Ages Eligible for Study: | 18 Years to 48 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy adult females
- A body mass index between 18 and 30 kg/m2, inclusive
- Negative urine drug and alcohol screen .
Exclusion Criteria:
- Significant medical condition,
- Significant physical examination finding
- Clinical laboratory
- ECG abnormality
- CYP2D6 "poor metabolizer"
Contacts and Locations| United States, New Jersey | |
| Clinical Research Center Advanced Biomedical Research Inc. | |
| Hackensack, New Jersey, United States, 07601 | |
| Study Director: | Ronald Wiehle, PhD | Repros Therapeutics Inc. |
More Information
No publications provided
| Responsible Party: | Ronald D. Wiehle, PhD, Repros Therapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00741468 History of Changes |
| Other Study ID Numbers: | ZP-007 |
| Study First Received: | August 25, 2008 |
| Last Updated: | February 10, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Repros Therapeutics Inc.:
|
Drug-drug interactions DDI |
ClinicalTrials.gov processed this record on June 13, 2013