Status:
COMPLETED
Evaluate the Safety and PK of Proellex® in Female Patients With Impaired Hepatic Function and Healthy Adults
Lead Sponsor:
Repros Therapeutics Inc.
Conditions:
Impaired Liver Function
Eligibility:
FEMALE
18-62 years
Phase:
PHASE1
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 func...
Detailed Description
16 subjects will be allocated to 2 groups. The test group will consist of 8 female patients with moderately impaired hepatic function meeting the Child-Pugh Class B severity criteria, while the contro...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00741273
Start Date
October 1 2008
End Date
June 1 2009
Last Update
August 28 2014
Active Locations (2)
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1
Clinical Pharmacology of Miami, Inc.
Miami, Florida, United States, 33014-3616
2
Orlando Clinical Research Center
Orlando, Florida, United States, 32809