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

A Single-Dose, Open-Label, Parallel Group Study To Evaluate The Pharmacokinetics And Safety Profile Of PROELLEX® (CDB-4124) In Female Subjects With Various Stages Of Impaired Renal Function And In Healthy Female Volunteers

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

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

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