Proellex Pharmacokinetics Bridging Study

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: 25 mg Proellex; Drug: 50 mg Proellex

• Registration Number: NCT01067807
• Lead Sponsor: Repros Therapeutics Inc.

Brief Summary

Healthy female subjects received a single dose of four different types of Proellex, the original 25 mg dose and three new formulations

Detailed Description

Healthy female subjects received a single dose of four different types of Proellex, the original 25 mg dose and three new formulations (24 and 50 mg dose). Blood was collected pre-dose, at specified intervals and 24 hours post dose. Each dose was separated by at least one week interval from the previous dose.

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Study First Submitted: 2010-02-10
• Study First Submitted QC: 2010-02-10
• Study First Posted: 2010-02-12
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-03
• Last Update Posted: 2014-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

Inclusion Criteria

• Medically normal subjects with no significant abnormal findings at the screening physical examination as evaluated by the clinical Investigator
• Subject was willing to remain in the clinic for the screening visit; and for the treatment visits (day -1, day of treatment and day 1; approximately 36 hrs per treatment visit)

Exclusion Criteria

• Post-menopausal women,
• Subject with documented endometriosis
• Subject with known uterine fibroids or vaginal polyps

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Proellex Formulation 1	25 mg Proellex	25 mg Proellex Gelucire and PEG (original formulation)
25 mg Proellex Formulation 2	25 mg Proellex	25 mg Proellex coated with MCC
25 mg Proellex Formulation 3	25 mg Proellex	25 mg Proellex blended with MCC
50 mg Proellex Formulation 3	50 mg Proellex	50 mg Proellex blended with MCC

Primary Outcome Measures

Name	Time	Method
Proellex peak plasma concentration (Cmax)	24 hours
Proellex time to peak plasma concentration (tmax).	24 hours

Secondary Outcome Measures

Name	Time	Method
Terminal elimination half-life (t1/2).	24 hours
Vital signs evaluated at screening, treatment days 0 and 1. Clinical laboratory values obtained at screening, treatment days 0 and 1. Adverse events assessed at treatment visits and followed until resolution.	24 hours
The area under the plasma concentration over time curve from zero to the last measurable Proellex plasma concentration (AUC0-24) was calculated.	24 hours
The area under the plasma concentration over time curve from zero to infinity (AUC 0-infinity).	24 hours

Trial Locations

Locations (1)

Healthcare Discoveries, Inc; 🇺🇸 San Antonio,, Texas, United States