Crossover Study of the Safety and PK Properties of Proellex®

Phase 1

Completed

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.

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
25 mg AMCC fed	Proellex	25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fed State
50 mg AMCC fed	Proellex	2, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fed State
50 mg AMCC fasting	Proellex	2, 25 mg Proellex capsules formulated with AMCC coarse microcrystalline cellulose Fasting State
50 mg SMCC fasting	Proellex	2, 25 mg Proellex capsules formulated with SMCC microcrystalline cellulose Fasting State
25 mg AMCC fasting	Proellex	25 mg Proellex capsule formulated with AMCC coarse microcrystalline cellulose Fasting State

Primary Outcome Measures

Name	Time	Method
Cmax of Proellex	Up to 72 hours post-dose	Maximum observed concentration of Proellex
Terminal Elimination Half-life (T1/2) of Proellex	Up to 72 hours post dose	Time to maximum plasma occurrence of T1/2, calculated as ln(2)/Elimination rate constant.
AUC0-last of Proellex	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.
Tmax of Proellex	Up to 72 hours post dose	Time to maximum plasma occurrence of Cmax
AUC0-infinity of Proellex	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