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

• ClinicalTrials.gov Identifier: NCT00787618
• Recruitment Status: Terminated
• First Posted: November 7, 2008
• Results First Posted: August 25, 2014
• Last Update Posted: August 25, 2014
• Sponsor: Repros Therapeutics Inc.
• Information provided by (Responsible Party): Repros Therapeutics Inc.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Renal Impairment	Drug: 50 mg Proellex	Phase 1; Phase 2

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 6 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• 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 Start Date: October 2008
• Actual Primary Completion Date: June 2009
• Actual Study Completion Date: July 2009

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 50 mg Proellex Mild impairment; 50 mg Proellex single dose Female subjects with mild renal impairment function.	Drug: 50 mg Proellex; Single dose; Other Names: Telapristone acetate; Proellex
Active Comparator: 50 mg Proellex Moderate; 50 mg Proellex, Female subjects with moderate renal impairment function.	Drug: 50 mg Proellex; Single dose; Other Names: Telapristone acetate; Proellex
Active Comparator: 50 mg Proellex, Normal; 50 mg Proellex, Female subjects with normal renal function.	Drug: 50 mg Proellex; Single dose; Other Names: Telapristone acetate; Proellex

Outcome Measures

Primary Outcome Measures :

1. Cmax of Proellex [ Time Frame: 48 hours ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 48 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Florida

Clinical Pharmacology of Miami, Inc

Miami, Florida, United States, 33014-3616

Orlando Clinical Research Center

Orlando, Florida, United States, 32809

United States, Minnesota

DaVita Clinical Research

Minneapolis, Minnesota, United States, 55404

United States, Tennessee

New Orleans Center for Clinical Research - Knoxville

Knoxville, Tennessee, United States, 37920

Sponsors and Collaborators

Repros Therapeutics Inc.

Investigators

• Study Director: Andre van As, MD, PhD; Repros Therapeutics Inc.

More Information

• Responsible Party: Repros Therapeutics Inc.
• ClinicalTrials.gov Identifier: NCT00787618
• Other Study ID Numbers: ZP-006
• First Posted: November 7, 2008
• Results First Posted: August 25, 2014
• Last Update Posted: August 25, 2014
• Last Verified: August 2014

Keywords provided by Repros Therapeutics Inc.:

Renal impairment

Additional relevant MeSH terms:

Renal Insufficiency; Kidney Diseases; Urologic Diseases