Crossover Study of the Safety and PK Properties of Proellex®

NCT00749879 | Completed Phase 1 Results

• 1 other identifier: ZP-008
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacokinetics

Keywords

PK; Pharmacokinetics

Outcome Measures

Primary Outcomes (5)

• Cmax of Proellex

  Maximum observed concentration of Proellex

  Up to 72 hours post-dose

• AUC0-last of Proellex

  Area under the plasma concentration curve from time 0 to the last measurable plasma concentration time point, up to 72 hours.

  Up to 72 hours post dose

• Tmax of Proellex

  Time to maximum plasma occurrence of Cmax

  Up to 72 hours post dose

• AUC0-infinity of Proellex

  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

  Up to 72 hours post dose

• Terminal Elimination Half-life (T1/2) of Proellex

  Time to maximum plasma occurrence of T1/2, calculated as ln(2)/Elimination rate constant.

  Up to 72 hours post dose

Study Arms (5)

25 mg AMCC fed

EXPERIMENTAL

25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fed State

Drug: Proellex

25 mg AMCC fasting

EXPERIMENTAL

25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fasting State

Drug: Proellex

50 mg AMCC fed

EXPERIMENTAL

2, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fed State

Drug: Proellex

50 mg AMCC fasting

EXPERIMENTAL

2, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fasting State

Drug: Proellex

50 mg SMCC fasting

EXPERIMENTAL

2, 25 mg Proellex capsules formulated with SMCC microcrystalline cellulose Fasting State

Drug: Proellex

Interventions

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

Also known as: Telapristone acetate

25 mg AMCC fasting; 25 mg AMCC fed; 50 mg AMCC fasting; 50 mg AMCC fed; 50 mg SMCC fasting

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Repros Therapeutics Inc.: lead

Study Sites (1)

Healthcare Discoveries Inc.

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

telapristone acetate

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Repros Therapeutics Inc, an Allergan Affiliate

IR-CTRegistration@allergan.com

714-246-4500

Study Officials

• Anna Chan

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2008
• First Posted: September 9, 2008
• Study Start: August 11, 2008
• Primary Completion: October 23, 2008
• Study Completion: October 23, 2008
• Last Updated: April 29, 2019
• Results First Posted: April 29, 2019

Record last verified: 2019-01

Locations

US (1)