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

This study has been terminated.
(Increased LFTs)
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00787618
First received: November 6, 2008
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Renal Impairment
Drug: 50 mg Proellex
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:
  • Cmax of Proellex [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: October 2008
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 48 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787618

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

No publications provided

Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00787618     History of Changes
Other Study ID Numbers: ZP-006
Study First Received: November 6, 2008
Results First Received: June 25, 2014
Last Updated: August 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Repros Therapeutics Inc.:
Renal impairment

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 22, 2014