Open-Label, Multiple-Dose, Non-Randomized Study to Assess Drug-Drug Interactions of Proellex® in Female Subjects - Full Text View

Sponsored by:	Repros Therapeutics Inc.
Information provided by:	Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:	NCT00741468

Purpose

This study will assess possible drug-drug interactions with specific isoenzymes over a total study duration of 6-8 weeks. Blood samples collected pre and post-dose, and urine samples collected post dose will be analyzed.

Condition	Intervention	Phase
Drug Interactions	Drug: Proellex®	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study
Official Title:	An Open-Label, Multiple-Dose, Non-Randomized Study to Assess the Drug-Drug Interactions of Proellex® (CDB-4124) With Cytochrome P450 Isoenzymes CYP1A2, 2C9, 2C19, 2D6, and 3A4 in Healthy Female Subjects

Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:

Assessment of the drug-drug interactions of Proellex® (CDB-4124) with cytochrome P450 isoenzymes CYP1A2, 2C9, 2C19, 2D6, and 3A4 in healthy female subjects administered 50 mg Proellex® once daily (QD). [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Determine the safety and tolerability of Proellex® in healthy female subjects administered 50 mg QD. [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	18
Study Start Date:	July 2008
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Proellex 50 mg	Drug: Proellex® 2, 25 mg Proellex capsules administered daily

Detailed Description:

This is an open-label, multiple-dose, non-randomized study to assess the drug-drug interactions of Proellex® with cytochrome P450 isoenzymes in healthy female subjects. On Day 1, following an overnight fast and morning void of the bladder, subjects will be administered CYP probe drugs orally. Serial blood samples will be collected at pre-dose and post-dose. Subjects will be administered two Proellex® 25 mg capsules (50 mg total dose) at approximately 0800 hours on Day 2 and 0700 hours on Days 3 through 8. One hour after administration of Proellex® on Day 8, the five CYP probe drugs will be administered and blood and urine samples collected as on Day 1. Blood samples for the determination of plasma concentrations of CDB-4124 and its metabolite CDB-4453 will be collected at pre-dose (trough) on Days 6, 7, and 8 to determine if steady-state conditions have been achieved. Samples will also be collected on Day 8 at 1, 2, 8 and 24 hour after administration of Proellex® to determine the plasma concentrations of CDB-4124 and CDB-4453.

Eligibility

Ages Eligible for Study:	18 Years to 48 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy adult females
A body mass index between 18 and 30 kg/m2, inclusive
Negative urine drug and alcohol screen .

Exclusion Criteria:

Significant medical condition,
Significant physical examination finding
Clinical laboratory
ECG abnormality
CYP2D6 "poor metabolizer"

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00741468

Contacts

Contact: Philip Krieter, PhD

609-818-1800 ext 127

phil.krieter@abr-clinical.com

Locations

United States, New Jersey
Clinical Research Center Advanced Biomedical Research Inc.	Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Benno Roesch, MD 201-678-0288 ext 136 ben.roesch@abr-clinical.com
Principal Investigator: Benno G. Roesch, MD

Sponsors and Collaborators

Repros Therapeutics Inc.

Investigators

Study Director:

Ronald Wiehle, PhD

Repros Therapeutics Inc.

More Information

Responsible Party:	Repros Therapeutics, Inc. ( Ronald D. Wiehle, PhD )
Study ID Numbers:	ZP-007
Study First Received:	August 25, 2008
Last Updated:	August 25, 2008
ClinicalTrials.gov Identifier:	NCT00741468
Health Authority:	United States: Food and Drug Administration

Keywords provided by Repros Therapeutics Inc.:

Drug-drug interactions
DDI

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009