NCT02141061

Comparison of Two Formulations of Proellex for Oral Administration

A Double-Blind Crossover Study in Healthy Volunteers to Compare Two Formulations of Proellex for Oral Administration

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Female
• Age: 18 Years – 47 Years
• Healthy volunteers: Accepted

Summary

This study is a double-blind crossover study in female healthy volunteers to compare the pharmacokinetics and safety of a single dose each of two different formulations of Proellex for oral administration. Each formulation will be designated as either Treatment A or Treatment B. A total of 12 subjects who meet the eligibility criteria will be randomized to receive either Treatment A or Treatment B as their first assigned treatment. After a 7-day washout period subjects will receive the alternative treatment. On the day of each treatment subjects will remain in the clinic overnight and undergo 72-hour pharmacokinetic assessment at the following time points: 0, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 and 72 hours after administration of study drug.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Telapristone Acetate, Proellex 12 mg Formulation A
DRUG	Telapristone Acetate, Proellex 12 mg Formulation B

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2014-05-19
• Last updated: 2014-09-03

Locations

1 site across 1 country: United States