Status: Currently recruiting patients in U.S.
Purpose:
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.
Eligibility:
Females, ages 18 years to 62 years
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Drug:
Proellex® 25mg and 50mg
Study Design:
Other, Non-Randomized, Open label, uncontrolled, Parallel Assignment, Safety Study
Primary Outcome Measures:
To compare the safety profile of a single dose of 25mg and 50mg of Proellex® in female patients with impaired hepatic function and in volunteers with normal hepatic function. [Time Frame: 3 days] [Designated as safety issue: Yes]
Secondary Outcome Measures:
To determine and compare the pharmacokinetics (PK) of a single dose of 25mg and 50mg of Proellex® in female patients with impaired hepatic func tion and in volunteers with normal hepatic function. [Time Frame: 3 days] [Designated as safety issue: Yes]
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Study Director:
Andre van As, MD, PhD
Repros Therapeutics Inc.
If you meet the study criteria and are interested in participating in the study, please contact:
Study Manager:
Hong Ma
inVentiv Clinical Solutions
281-376-6655
Current Clinical Site Locations:
Miami, FL
Orlando, FL
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