Crossover Study of the Safety and PK Properties of Proellex®

Repros Therapeutics

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: Proellex

Study type: Interventional

Funder types: Industry

Identifiers

NCT00749879

ZP-008

Details and patient eligibility

About

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

Full 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.

Enrollment: 17 patients

Sex: Female

Ages: 18 to 34 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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17 participants in 5 patient groups

25 mg AMCC fed

Experimental group

Description:

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

Treatment:

Drug: Proellex

25 mg AMCC fasting

Experimental group

Description:

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

Treatment:

Drug: Proellex

50 mg AMCC fed

Experimental group

Description:

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

Treatment:

Drug: Proellex

50 mg AMCC fasting

Experimental group

Description:

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

Treatment:

Drug: Proellex

50 mg SMCC fasting

Experimental group

Description:

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

Treatment:

Drug: Proellex