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Completed

NCT Number: NCT00749879

Crossover Study of the Safety and PK Properties of Proellex®

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

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Key information

Conditions

Pharmacokinetics

Age range

18 year–34 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Healthcare Discoveries Inc.

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proellex

Drug

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 names: Telapristone acetate

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Repros Therapeutics Inc.

Industry

Registry information

Official study title

A Phase I, Open-Label, Randomized, Single-Center, Unblinded, Single-Dose, Five-Way Crossover Study of the Safety and PK Properties of Proellex®

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Sep 9, 2008
Registry last updated
Apr 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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