Status:
COMPLETED
Open-Label, Multiple-Dose, Non-Randomized Study to Assess Drug-Drug Interactions of Proellex® in Female Subjects
Lead Sponsor:
Repros Therapeutics Inc.
Conditions:
Drug Interactions
Eligibility:
FEMALE
18-48 years
Phase:
PHASE1
Brief 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 do...
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 overnigh...
Eligibility Criteria
Inclusion
- Healthy adult females
- A body mass index between 18 and 30 kg/m2, inclusive
- Negative urine drug and alcohol screen .
Exclusion
- Significant medical condition,
- Significant physical examination finding
- Clinical laboratory
- ECG abnormality
- CYP2D6 "poor metabolizer"
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00741468
Start Date
July 1 2008
End Date
October 1 2008
Last Update
August 22 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical Research Center Advanced Biomedical Research Inc.
Hackensack, New Jersey, United States, 07601