Evaluate the Safety and PK of Proellex® in Female Patients With Impaired Hepatic Function and Healthy Adults

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