Status:
TERMINATED
Evaluate PK and Safety of Proellex® in Females With Various Stages of Impaired Renal Function and Healthy Females
Lead Sponsor:
Repros Therapeutics Inc.
Conditions:
Renal Impairment
Eligibility:
FEMALE
18-48 years
Phase:
PHASE1
PHASE2
Brief Summary
PK and safety profile of Proellex® in females with various stages of impaired renal function
Detailed Description
The study will evaluate the pharmacokinetics and safety profile of Proellex® in females with various stages of impaired renal function and in volunteers with normal renal function
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, is preferred
- Subject must meet the criteria of mildly or moderately impaired renal function or have normal renal function
- Subject with renal impairment must have evidence of stable disease
- If on medications for treatment of the complications of renal disease, and other concommitant chronic illnesses, subject must have been taking the medications at a stable dose for at least 10 days prior to the first Proellex® dosing date and are then to be continued at the same dose for the duration of the study.
- Negative urine pregnancy test at screening visit
- Subject must agree to use a medically acceptable and effective non-hormonal double barrier method of birth control
- Healthy subject must have no significant abnormal findings at the screening physical examination
- Subject is willing to remain in the clinic for the screening visit (approximately 1 day for the first screening visit) and for the treatment visit (approximately 3 days)
- Additional inclusion criteria may apply
Exclusion
- Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant
- Subject with clinically significant abnormal liver function
- 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
- An acute illness within five (5) days of study medication administration
- Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system
- Additional exclusion criteria may apply
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00787618
Start Date
October 1 2008
End Date
July 1 2009
Last Update
August 25 2014
Active Locations (4)
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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
3
DaVita Clinical Research
Minneapolis, Minnesota, United States, 55404
4
New Orleans Center for Clinical Research - Knoxville
Knoxville, Tennessee, United States, 37920