Clinical trial NCT00787618: Evaluate PK and Safety of Proellex® in Females With Various Stages of Impaired Renal Function and Healthy Females
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Renal Impairment
Keywords: Renal impairment
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2008-11-07
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

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 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

Primary outcomes:
measure: Cmax of Proellex
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami, Inc
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Minneapolis
country: United States
facility: DaVita Clinical Research
state: Minnesota
city: Knoxville
country: United States
facility: New Orleans Center for Clinical Research - Knoxville
state: Tennessee
Study officials:
affiliation: Repros Therapeutics Inc.
name: Andre van As, MD, PhD
role: STUDY_DIRECTOR
References: