Evaluate the Safety and PK of Proellex® in Female Patients With Impaired Hepatic Function and Healthy Adults

NCT00741273 | Completed Phase 1 Results

• 1 other identifier: ZP-005
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

This study will evaluate the safety and pharmacokinetics of two doses of orally administered Proellex® in female patients with impaired hepatic function and healthy volunteers with normal hepatic function.

Conditions

Impaired Liver Function

Outcome Measures

Primary Outcomes (2)

• Maximum Blood Concentration (Cmax)

  Cmax of a single dose of 25mg and 50mg of Proellex® in female patients with impaired hepatic function and in volunteers with normal hepatic function, assessed from samples collected at: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 5, 7, 9, 12, 16, 20, 24, 32, 36, 40 and 48 hours post dose..

  48 hours

• Proellex Half-life (T1/2)

  Time for Proellex concentration to decrease by half (T1/2) of a single dose of 25mg and 50mg of Proellex® in female patients with impaired hepatic function and in volunteers with normal hepatic function,measured from samples collected at: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 5, 7, 9, 12, 16, 20, 24, 32, 36, 40 and 48 hours post dose..

  48 hours

Secondary Outcomes (1)

• Area Under the Curve (AUC0-t) for Proellex

  48 hours

Study Arms (2)

Proellex 25 mg healthy

EXPERIMENTAL

Proellex 25 mg in healthy females

Drug: Proellex

Proellex 25 mg Impaired

EXPERIMENTAL

Proellex 50 mg in hepatically impaired females

Drug: Proellex

Interventions

Proellex DRUG

Proellex 25 mg capsule, single dose

Also known as: Telapristone acetate

Proellex 25 mg Impaired; Proellex 25 mg healthy

Eligibility Criteria

• Age: 18 Years - 62 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Speak, read, and understand English or Spanish and is willing and able to provide written informed consent on an IRB-approved form prior to the initiation of any study procedures;
• Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive, are preferred; however, subjects up to 62 years old, inclusive, may participate;
• Subjects with moderate hepatic insufficiency must meet the Class B level of the Child-Pugh criteria;
• Subjects must have evidence of stable hepatic impairment;
• If on medications for treatment of the complications of liver disease, and other concomitant chronic illnesses, subjects must have been taking the medications at a stable dose for at least 10 days prior to the first dosing date and are then to be continued at the same dose for the duration of the study;
• Non-smokers are preferred, but light to moderate smoking will be allowed (no more than 10 cigarettes/day)
• Subject is willing to remain in the clinic for the screening visit and for two treatment visits (approximately 3 days for each treatment visit);

You may not qualify if:

• Past or present history of an allergic reaction to the formulations administered in this study, or in the opinion of the Investigator, suggesting an increased potential for an adverse hypersensitivity;
• Pregnant or lactating females, or women who are attempting or expecting to become pregnant at any time during the study or one month after the study;
• A physical illness within three (3) months of the study that would interfere with the study as determined by the Investigator;
• An acute illness within five (5) days of study medication administration;
• Positive urine drug screen at the screening visit based on laboratory testing;

Sponsors & Collaborators

• Repros Therapeutics Inc.: lead

Study Sites (2)

Clinical Pharmacology of Miami, Inc.

Miami, Florida, 33014-3616, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

MeSH Terms

Conditions

Liver Diseases

Interventions

telapristone acetate

Condition Hierarchy (Ancestors)

Digestive System Diseases

Results Point of Contact

• Title: Jennifer Wike
• Organization: Repros Therapeutics

jwike@reprosrx.com

2817193402

Study Officials

• Andre van As, MD, PhD

  Repros Therapeutics Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2008
• First Posted: August 26, 2008
• Study Start: October 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: June 1, 2009
• Last Updated: August 28, 2014
• Results First Posted: August 28, 2014

Record last verified: 2014-08

Locations

US (2)