Crossover Study of the Safety and PK Properties of Proellex®

Pharmacokinetics Clinical Trial

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®

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00749879
• Other study ID #: ZP-008
• Status: Completed
• Phase: Phase 1
• Start date: August 11, 2008
• Est. completion date: October 23, 2008

Study information

• Verified date: January 2019
• Source: Repros Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 23, 2008
• Est. primary completion date: October 23, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 34 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

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

Locations

Country	Name	City	State
United States	Healthcare Discoveries Inc.	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Repros Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of Proellex	Maximum observed concentration of Proellex	Up to 72 hours post-dose
Primary	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
Primary	Tmax of Proellex	Time to maximum plasma occurrence of Cmax	Up to 72 hours post dose
Primary	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
Primary	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