Crossover Study of the Safety and PK Properties of Proellex® - Full Text View

Purpose

This study is intended to evaluate the pharmacokinetic properties of two doses (25 mg and 50 mg) of Proellex® formulated with microcrystalline cellulose (MCC) from 2 different suppliers in the fed and fasting states.

Condition	Intervention	Phase
Pharmacokinetics	Drug: Proellex®	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	A Phase I, Open-Label, Randomized, Single-Center, Unblinded, Single-Dose, Five-Way Crossover Study of the Safety and PK Properties of Proellex®

Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:

Mean plasma concentrations of Proellex® will be plotted versus time. [ Time Frame: Up to 72 hours post-dose ] [ Designated as safety issue: Yes ]

Enrollment:	17
Study Start Date:	August 2008
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 25 mg Proellex capsule formulated with coarse microcrystalline cellulose Fed State	Drug: Proellex® 25 mg capsule administered once orally after subjects have been fed; 25 mg capsule administered once orally while subjects are fasting; 2, 25 mg capsules administered once orally after subjects have been fed; 2, 25 mg capsules administered once orally while subjects are fasting; and 2, 25 mg capsules administered once orally while subjects are fasting
Experimental: 2 25 mg Proellex capsule formulated with coarse microcrystalline cellulose Fasting State	Drug: Proellex® 25 mg capsule administered once orally after subjects have been fed; 25 mg capsule administered once orally while subjects are fasting; 2, 25 mg capsules administered once orally after subjects have been fed; 2, 25 mg capsules administered once orally while subjects are fasting; and 2, 25 mg capsules administered once orally while subjects are fasting
Experimental: 3 2, 25 mg Proellex capsules formulated with coarse microcrystalline cellulose Fed State	Drug: Proellex® 25 mg capsule administered once orally after subjects have been fed; 25 mg capsule administered once orally while subjects are fasting; 2, 25 mg capsules administered once orally after subjects have been fed; 2, 25 mg capsules administered once orally while subjects are fasting; and 2, 25 mg capsules administered once orally while subjects are fasting
Experimental: 4 2, 25 mg Proellex capsules formulated with coarse microcrystalline cellulose Fasting State	Drug: Proellex® 25 mg capsule administered once orally after subjects have been fed; 25 mg capsule administered once orally while subjects are fasting; 2, 25 mg capsules administered once orally after subjects have been fed; 2, 25 mg capsules administered once orally while subjects are fasting; and 2, 25 mg capsules administered once orally while subjects are fasting
Experimental: 5 2, 25 mg Proellex capsules formulated with microcrystalline cellulose Fasting State	Drug: Proellex® 25 mg capsule administered once orally after subjects have been fed; 25 mg capsule administered once orally while subjects are fasting; 2, 25 mg capsules administered once orally after subjects have been fed; 2, 25 mg capsules administered once orally while subjects are fasting; and 2, 25 mg capsules administered once orally while subjects are 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 in English on an Institutional Review Board (IRB)
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
Medically normal subjects with no significant abnormal findings at the screening physical examination as evaluated by the Principal Investigator that would interfere with the subject participating this study
Must have agreed to not attempt to become pregnant at any time during study participation or for 30 days thereafter
Other inclusion criteria may apply

Exclusion Criteria:

Symptomatic uterine fibroids or endometriosis
Past or present history of any significant cardiovascular, renal, or hepatic disease requiring ongoing medical therapy or clinical intervention
Past or present history of thrombophlebitis, thromboembolic disorders, or cerebrovascular accident
Abnormal screening visit vital signs or clinical laboratory evaluation considered clinically significant by the Principal Investigator
Significant organ abnormality or disease (based on the Principal Investigator's judgment) that would in the opinion of the Principal Investigator exclude the subject from participating
Other exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00749879

Locations

United States, Texas
Healthcare Discoveries Inc.
San Antonio, Texas, United States, 78229

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 vanAs, MD, PhD, Repros Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00749879 History of Changes
Other Study ID Numbers:	ZP-008
Study First Received:	September 5, 2008
Last Updated:	February 10, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Repros Therapeutics Inc.:

PK
Pharmacokinetics

ClinicalTrials.gov processed this record on June 18, 2013