- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00741273
Evaluate the Safety and PK of Proellex® in Female Patients With Impaired Hepatic Function and Healthy Adults
August 8, 2014 updated by: Repros Therapeutics Inc.
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
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Miami, Florida, United States, 33014-3616
- Clinical Pharmacology of Miami, Inc.
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Orlando, Florida, United States, 32809
- Orlando Clinical Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 62 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, 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Proellex 25 mg healthy
Proellex 25 mg in healthy females
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Proellex 25 mg capsule, single dose
Other Names:
|
Experimental: Proellex 25 mg Impaired
Proellex 50 mg in hepatically impaired females
|
Proellex 25 mg capsule, single dose
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Blood Concentration (Cmax)
Time Frame: 48 hours
|
Cmax of a single dose of 25mg and 50mg of Proellex® in female patients with impaired hepatic function and in volunteers with normal hepatic function, assessed from samples collected at: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 5, 7, 9, 12, 16, 20, 24, 32, 36, 40 and 48 hours post dose..
|
48 hours
|
Proellex Half-life (T1/2)
Time Frame: 48 hours
|
Time for Proellex concentration to decrease by half (T1/2) of a single dose of 25mg and 50mg of Proellex® in female patients with impaired hepatic function and in volunteers with normal hepatic function,measured from samples collected at: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 5, 7, 9, 12, 16, 20, 24, 32, 36, 40 and 48 hours post dose..
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under the Curve (AUC0-t) for Proellex
Time Frame: 48 hours
|
AUC0-t of a single dose of 25mg and 50mg of Proellex® in female patients with impaired hepatic function and in volunteers with normal hepatic function, measured from samples collected at: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 5, 7, 9, 12, 16, 20, 24, 32, 36, 40 and 48 hours post dose.
|
48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Andre van As, MD, PhD, Repros Therapeutics Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
August 25, 2008
First Submitted That Met QC Criteria
August 25, 2008
First Posted (Estimate)
August 26, 2008
Study Record Updates
Last Update Posted (Estimate)
August 28, 2014
Last Update Submitted That Met QC Criteria
August 8, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- ZP-005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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