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

Renal Impairment Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00787618
• Other study ID #: ZP-006
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: November 6, 2008
• Last updated: August 8, 2014
• Start date: October 2008
• Est. completion date: July 2009

Study information

• Verified date: August 2014
• Source: Repros Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: July 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• 50 mg Proellex
Single dose

Locations

Country	Name	City	State
United States	New Orleans Center for Clinical Research - Knoxville	Knoxville	Tennessee
United States	Clinical Pharmacology of Miami, Inc	Miami	Florida
United States	DaVita Clinical Research	Minneapolis	Minnesota
United States	Orlando Clinical Research Center	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Repros Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of Proellex		48 hours	Yes