NCT00741468

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Female
• Age: 18 Years – 48 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Drug Interactions

Interventions

Type	Name	Description
DRUG	Proellex	2, 25 mg Proellex capsules administered daily
DRUG	CYP1A2 probe	Caffeine (200 mg)
DRUG	CYP2C9 probe	Tolbutamide (250 mg)
DRUG	CYP2C19 probe	Omeprazole (20 mg)
DRUG	CYP2D6 probe	Dextromethorphan (30 mg)
DRUG	CYP3A4 probe	Midazolam (2mg)

Timeline

• Start date: 2008-07-01
• Primary completion: 2008-09-01
• Completion: 2008-10-01
• First posted: 2008-08-26
• Last updated: 2014-08-22
• Results posted: 2014-08-22

Locations

1 site across 1 country: United States