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

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

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

Study Overview

• Status: Terminated
• Conditions: Renal Impairment
• Intervention / Treatment: Drug: 50 mg Proellex

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33014-3616
      • Clinical Pharmacology of Miami, Inc
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Davita Clinical Research
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • New Orleans Center For Clinical Research - Knoxville

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax of Proellex	48 hours

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: November 6, 2008
• First Submitted That Met QC Criteria: November 6, 2008
• First Posted (Estimate): November 7, 2008

Study Record Updates

• Last Update Posted (Estimate): August 25, 2014
• Last Update Submitted That Met QC Criteria: August 8, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Renal impairment
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: ZP-006