NCT00619385

A Safety and Pharmacokinetic Study of Proellex®

A Safety and Pharmacokinetic Study of 100 mg, 150 mg and 200 mg of Proellex® Taken for Seven Days by Healthy Adult Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Female
• Age: 18 Years – 34 Years
• Healthy volunteers: Accepted

Summary

Dose escalating study of 7 daily doses of Proellex at 100 mg, 150 mg and 200 mg

Detailed description

This is an open-label, single-center, outpatient, unblinded, multi-dose study of the safety and pharmacokinetic properties of Proellex®. Six female subjects will each receive seven daily doses of Proellex® in separate, rising doses. Dosing must be accomplished between menstrual periods. The first six women will complete the 100 mg visit schedule before the next six women will begin the 150 mg visit schedule. Blood will be collected at pre-dose, and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 24 and 36 (Day 7 only) hrs post-dose on Day 1 and Day 7. Subjects will be allowed to leave the clinic between the 12 and 24 hr and the 24 and 36 hr PK blood draws. Subjects will be discharged from the study after a one month follow-up visit. Safety will be assessed throughout the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Proellex	Proellex 25 mg capsules 100 mg, 150 mg or 200mg daily for 7 days

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-09-01
• Completion: 2008-10-01
• First posted: 2008-02-21
• Last updated: 2014-08-08
• Results posted: 2014-07-28

Locations

1 site across 1 country: United States