Crossover Study of the Safety and PK Properties of Proellex®

This study has been completed.
Sponsor:
Information provided by:
Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT00749879
First received: September 5, 2008
Last updated: February 10, 2010
Last verified: February 2010
  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 April 16, 2014