Evaluate the Safety and PK of Proellex® in Female Patients With Impaired Hepatic Function and Healthy Adults

This study has been completed.
Sponsor:
Information provided by:
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00741273
First received: August 25, 2008
Last updated: February 10, 2010
Last verified: February 2010
  Purpose

This study will evaluate the safety and pharmacokinetics of two doses of orally administered Proellex® in female patients with impaired hepatic function and healthy volunteers with normal hepatic function.


Condition Intervention Phase
Impaired Liver Function
Healthy Volunteers
Drug: Proellex
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: An Open-label, Two-stage, Dose-escalation, Parallel Group Study to Evaluate the Safety and Pharmacokinetics Profile of Proellex® (CDB-4124) in Female Patients With Impaired Hepatic Function and Healthy Adult Volunteers

Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:
  • To compare the safety profile of a single dose of 25mg and 50mg of Proellex® in female patients with impaired hepatic function and in volunteers with normal hepatic function. [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine and compare the pharmacokinetics (PK) of a single dose of 25mg and 50mg of Proellex® in female patients with impaired hepatic function and in volunteers with normal hepatic function. [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 16
Study Start Date: October 2008
Study Completion Date: June 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Proellex 25 mg in healthy females
Drug: Proellex
Proellex 25 mg capsule, single dose
Experimental: B
Proellex 50 mg in hepatically impaired females
Drug: Proellex
Proellex 2, 25 mg capsules, single dose

Detailed Description:

16 subjects will be allocated to 2 groups. The test group will consist of 8 female patients with moderately impaired hepatic function meeting the Child-Pugh Class B severity criteria, while the control group will consist of 8 healthy female adult volunteers. During Stage I, all subjects will receive a single oral dose of 25mg of Proellex® (fasting state) and be followed in a Clinical Research Unit (CRU) for about three days. Only subjects who do not experience serious adverse events (SAEs) or adverse events (AEs) that are determined by Investigator to be possibly, probably or definitely related to the treatment will participate in Stage II. The dose will be increased to a single dose of 50mg of Proellex® (fasting state) and subjects will be followed in a Clinical Research Unit (CRU) for about three days. Subjects will undergo blood draws at several time points.

  Eligibility

Ages Eligible for Study:   18 Years to 62 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, are preferred; however, subjects up to 62 years old, inclusive, may participate;
  • Subjects with moderate hepatic insufficiency must meet the Class B level of the Child-Pugh criteria;
  • Subjects must have evidence of stable hepatic impairment;
  • If on medications for treatment of the complications of liver disease, and other concomitant chronic illnesses, subjects must have been taking the medications at a stable dose for at least 10 days prior to the first dosing date and are then to be continued at the same dose for the duration of the study;
  • Non-smokers are preferred, but light to moderate smoking will be allowed (no more than 10 cigarettes/day)
  • Subject is willing to remain in the clinic for the screening visit and for two treatment visits (approximately 3 days for each treatment visit);
  • Other inclusion criteria may apply

Exclusion Criteria:

  • Past or present history of an allergic reaction to the formulations administered in this study, or in the opinion of the Investigator, suggesting an increased potential for an adverse hypersensitivity;
  • 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;
  • A physical illness within three (3) months of the study that would interfere with the study as determined by the Investigator;
  • An acute illness within five (5) days of study medication administration;
  • Positive urine drug screen at the screening visit based on laboratory testing;
  • Other 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: NCT00741273

Locations
United States, Florida
Clinical Pharmacology of Miami, Inc.
Miami, Florida, United States, 33014-3616
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
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
ClinicalTrials.gov Identifier: NCT00741273     History of Changes
Other Study ID Numbers: ZP-005
Study First Received: August 25, 2008
Last Updated: February 10, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Repros Therapeutics Inc.:
Impaired Liver Function
Healthy Volunteers

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 22, 2014