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Crossover Study of the Safety and PK Properties of Proellex®

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00749879
First Posted: September 9, 2008
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Repros Therapeutics Inc.
  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
Intervention Model: Crossover Assignment
Masking: None (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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 34 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Andre vanAs, MD, PhD, Repros Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00749879     History of Changes
Other Study ID Numbers: ZP-008
First Submitted: September 5, 2008
First Posted: September 9, 2008
Last Update Posted: October 12, 2017
Last Verified: February 2010

Keywords provided by Repros Therapeutics Inc.:
PK
Pharmacokinetics