Evaluate PK and Safety of Proellex® in Females With Various Stages of Impaired Renal Function and Healthy Females

• Status: Terminated
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: Female

Summary

PK and safety profile of Proellex® in females with various stages of impaired renal function

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Repros Therapeutics Inc.

Criteria

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, 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 Criteria:

• 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