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

Completed · Phase 1

Conditions studied: Impaired Liver Function

In brief

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.

Key facts

Study ID

NCT00741273

Run by

Repros Therapeutics Inc.

People needed

16

Starts

2008-10-01

Expected to finish

2009-06-01

Last updated by the study team

2014-08-28

Who can join

Age: 18 and older, up to 62. Sex: female. Healthy volunteers: accepted.

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);
• Other inclusion criteria may apply

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;
• Other exclusion criteria may apply

Where it is running

• Clinical Pharmacology of Miami, Inc. — Miami, Florida, United States
• Orlando Clinical Research Center — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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