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

Repros Therapeutics

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Renal Impairment

Treatments

Drug: 50 mg Proellex

Study type

Interventional

Funder types

Industry

Identifiers

NCT00787618

ZP-006

Details and patient eligibility

About

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

Full 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

Enrollment

6 patients

Sex

Female

Ages

18 to 48 years old

Volunteers

Accepts Healthy Volunteers

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