Clinical trial NCT00741273: Evaluate the Safety and PK of Proellex® in Female Patients With Impaired Hepatic Function and Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Impaired Liver Function
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2008-08-26
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

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 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

Primary outcomes:
measure: Maximum Blood Concentration (Cmax)
timeFrame: 48 hours
measure: Proellex Half-life (T1/2)
timeFrame: 48 hours
Secondary outcomes:
measure: Area Under the Curve (AUC0-t) for Proellex
timeFrame: 48 hours
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami, Inc.
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
Study officials:
affiliation: Repros Therapeutics Inc.
name: Andre van As, MD, PhD
role: STUDY_DIRECTOR
References: