Open-Label, Multiple-Dose, Non-Randomized Study to Assess Drug-Drug Interactions of Proellex® in Female Subjects

Completed · Phase 1

Conditions studied: Drug Interactions

In brief

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.

Key facts

Study ID

NCT00741468

Run by

Repros Therapeutics Inc.

People needed

18

Starts

2008-07-01

Expected to finish

2008-10-01

Last updated by the study team

2014-08-22

Who can join

Age: 18 and older, up to 48. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Healthy adult females
• A body mass index between 18 and 30 kg/m2, inclusive
• Negative urine drug and alcohol screen .

You may not qualify if…

• Significant medical condition,
• Significant physical examination finding
• Clinical laboratory
• ECG abnormality
• CYP2D6 "poor metabolizer"

Where it is running

• Clinical Research Center Advanced Biomedical Research Inc. — Hackensack, New Jersey, United States

Full record on ClinicalTrials.gov

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