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:
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00787618
First received: November 6, 2008
Last updated: August 25, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Renal Function
Drug: 50mg of 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:
  • To determine and compare the pharmacokinetics (PK) of a single dose of 50mg of Proellex® in female patients with various stages of impaired renal function and in volunteers with normal renal function. [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To compare the safety profile of a single dose of 50mg of Proellex® in female patients with various stages of impaired renal function and in volunteers with normal renal function. [ Time Frame: 48 hrs ] [ Designated as safety issue: Yes ]

Enrollment: 21
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: 1
Female subjects with mild renal impairment function.
Drug: 50mg of Proellex®
Single dose
Active Comparator: 2
Female subjects with moderate renal impairment function.
Drug: 50mg of Proellex®
Single dose
Active Comparator: 3
Female subjects with normal renal function.
Drug: 50mg of Proellex®
Single dose

  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
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: Andre van As, MD, PhD, Repros Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00787618     History of Changes
Other Study ID Numbers: ZP-006
Study First Received: November 6, 2008
Last Updated: August 25, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Repros Therapeutics Inc.:
Renal function

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 14, 2014