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Crossover Study of the Safety and PK Properties of Proellex®

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ClinicalTrials.gov Identifier: NCT00749879
Recruitment Status : Completed
First Posted : September 9, 2008
Results First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Repros Therapeutics Inc.

Brief Summary:
Study to evaluate the PK of 25 mg and 50 mg of Proellex from 2 different suppliers in the fed and fasting states.

Condition or disease Intervention/treatment Phase
Pharmacokinetics Drug: Proellex Phase 1

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
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®
Actual Study Start Date : August 11, 2008
Actual Primary Completion Date : October 23, 2008
Actual Study Completion Date : October 23, 2008

Arm Intervention/treatment
Experimental: 25 mg AMCC fed

25 mg Proellex capsule formulated with AMCC 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
Other Name: Telapristone acetate

Experimental: 25 mg AMCC fasting

25 mg Proellex capsule formulated with AMCC 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
Other Name: Telapristone acetate

Experimental: 50 mg AMCC fed

2, 25 mg Proellex capsules formulated with AMCC 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
Other Name: Telapristone acetate

Experimental: 50 mg AMCC fasting

2, 25 mg Proellex capsules formulated with AMCC 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
Other Name: Telapristone acetate

Experimental: 50 mg SMCC fasting

2, 25 mg Proellex capsules formulated with SMCC 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
Other Name: Telapristone acetate




Primary Outcome Measures :
  1. Cmax of Proellex [ Time Frame: Up to 72 hours post-dose ]
    Maximum observed concentration of Proellex

  2. AUC0-last of Proellex [ Time Frame: Up to 72 hours post dose ]
    Area under the plasma concentration curve from time 0 to the last measurable plasma concentration time point, up to 72 hours.

  3. Tmax of Proellex [ Time Frame: Up to 72 hours post dose ]
    Time to maximum plasma occurrence of Cmax

  4. AUC0-infinity of Proellex [ Time Frame: Up to 72 hours post dose ]
    Area under the plasma concentration curve from time 0 to extrapolated to infinity, calculated by summing the area under the curve from time zero to the time of the last quantifiable concentration

  5. Terminal Elimination Half-life (T1/2) of Proellex [ Time Frame: Up to 72 hours post dose ]
    Time to maximum plasma occurrence of T1/2, calculated as ln(2)/Elimination rate constant.



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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

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
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United States, Texas
Healthcare Discoveries Inc.
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Repros Therapeutics Inc.
Investigators
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Study Director: Anna Chan Allergan

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Responsible Party: Repros Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00749879     History of Changes
Other Study ID Numbers: ZP-008
First Posted: September 9, 2008    Key Record Dates
Results First Posted: April 29, 2019
Last Update Posted: April 29, 2019
Last Verified: January 2019

Keywords provided by Repros Therapeutics Inc.:
PK
Pharmacokinetics