NCT00620503

Proellex® Pharmacokinetic Bridging Study II

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Female
• Age: 18 Years – 34 Years
• Healthy volunteers: Accepted

Summary

An open-label, randomized, single-center, outpatient, unblinded, single-dose, three-way crossover study of the safety and PK properties of Proellex® in women ages 18 - 34 years.

Detailed description

This is an open-label, randomized, single-center, outpatient, unblinded, single-dose, three-way crossover study of the safety and PK properties of Proellex® in women ages 18 - 34 years. Twelve female subjects will each receive a single dose of Proellex®: 25 mg (fed state, formulation A), 25 mg (fed state, formulation B), and 25 mg (fasting state, formulation B); successive dosing will be separated by at least one week intervals from the previous dosing. Blood will be collected prior to taking the dose, and following the dose for 24 hours post-dose. Subjects will be discharged from the study after the last blood sample is obtained after the third dose of Proellex®. Safety will be assessed throughout the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Proellex 25 mg formulation A	One Proellex 25 mg formulation A capsule
DRUG	Proellex 25 mg formulation B	One 25 mg Proellex capsule formulation B administered both fed and fasted

Timeline

• Start date: 2008-02-29
• Primary completion: 2008-04-30
• Completion: 2008-04-30
• First posted: 2008-02-21
• Last updated: 2019-06-21
• Results posted: 2019-06-21

Locations

1 site across 1 country: United States