Proellex® Pharmacokinetic Bridging Study II - Full Text View

Purpose

This is an open-label, randomized, single-center, outpatient, unblinded, single-dose, three-way crossover study of the safety and PK properties of Proellex® in women ages 18 - 34 years. Twelve female subjects will each receive a single dose of Proellex®: 25 mg (fed state, formulation A), 25 mg (fed state, formulation B), and 25 mg (fasting state, formulation B); successive dosing will be separated by at least one week intervals from the previous dosing. Blood will be collected prior to taking the dose, and following the dose for 24 hours post-dose. Subjects will be discharged from the study after the last blood sample is obtained after the third dose of Proellex®. Safety will be assessed throughout the study.

Condition	Intervention	Phase
Healthy	Drug: Proellex 25 mg	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics Study

Official Title:	Proellex® Pharmacokinetic Bridging Study II

Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:

To determine and compare the pharmacokinetic (PK) properties of a single dose of Proellex® (25 mg) using two different formulations of the drug in healthy adult female subjects with or without fasting [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine and compare the safety of a single dose of Proellex® (25 mg) using two formulations of the drug in healthy adult female subjects with or without fasting [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Enrollment:	12
Study Start Date:	February 2008
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Proellex 25 mg formulation A	Drug: Proellex 25 mg One Proellex 25 mg capsule for one day administered after being fed
B: Experimental Proellex 25 mg formulation B	Drug: Proellex 25 mg One Proellex 25 mg capsule for one day administered after being fed
C: Experimental Proellex 25 mg formulation B	Drug: Proellex 25 mg One 25 mg Proellex capsule for one day administered while fasting

Eligibility

Ages Eligible for Study:	18 Years to 34 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subject must be able to speak, read and understand English and be willing and able to provide written informed consent on an Institutional Review Board (IRB)-approved form prior to the initiation of any study procedures. Subject must have signed and dated a written Informed Consent Form (ICF) before undergoing any study related activities, including discontinuation of any prohibited medications
Premenopausal women aged 18 - 34 inclusive with body mass index between 18 and 35 inclusive
Women of child-bearing potential must be willing to use effective non-hormonal, double-barrier method contraception during the study period and for a minimum of 30 days after discontinuation of the study medication. Women who have had a hysterectomy will be allowed into the study
Must have a negative urine pregnancy test at screening
Able to swallow gelatin capsules
In general good health
Must have agreed to not attempt to become pregnant at any time during study participation or for 30 days thereafter
Must not have used tobacco (nicotine products) for at least two years before the study starts
Must have normal (or abnormal and clinically insignificant) laboratory values at screening
Willing to remain in the clinic for the screening visit and for the treatment visits
Available for all treatment and follow-up visits
Willing to comply with all study procedures
Additional inclusion criteria may apply

Exclusion Criteria:

Pregnant or lactating females or women who are attempting or expecting to become pregnant at any time during the study
Past or present history of experiencing any allergic reaction to the formulations administered in this study, or in the opinion of the Principal Investigator, suggests an increased potential for an adverse hypersensitivity
Any medical condition, which, in the judgment of the Principal Investigator, will prevent the subject from starting and/or completing the study
Past or present history of any significant cardiovascular, renal, hepatic disease, thrombophlebitis, thromboembolic disorders, or cerebrovascular accident requiring ongoing medical therapy or clinical intervention
A QTc interval of >450ms at screening
Subject with abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Principal Investigator
Subjects with symptomatic uterine fibroids or endometriosis
Use of other oral contraceptives or hormonal treatments within 30 days of first dose of study medication
Use of a hormone-releasing intrauterine device
Subject with a history of alcohol and/or drug abuse
Known active infection of HIV, Hepatitis A, B or C
Subject who has participated in a clinical trial with investigational medication within 30 days prior to study medication administration or who plans to take an experimental drug prior to the end of 30 days after participation in this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620503

Locations


United States, Texas
	Healthcare Discoveries Inc.
	San Antonio, Texas, United States, 78209

Sponsors and Collaborators

Repros Therapeutics Inc.

Investigators


Study Director:	Andre vanAs, MD, PhD	Repros Therapeutics Inc.

More Information

Responsible Party:	Repros Therapeutics, Inc. ( Andre vanAs, MD, PhD )
Study ID Numbers:	ZP-002
First Received:	February 4, 2008
Last Updated:	May 20, 2008
ClinicalTrials.gov Identifier:	NCT00620503
Health Authority:	United States: Food and Drug Administration

Keywords provided by Repros Therapeutics Inc.:

PK

Pharmacokinetics

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Repros Therapeutics Inc.
Information provided by:	Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:	NCT00620503