Clinical trial NCT00749879: Crossover Study of the Safety and PK Properties of Proellex®
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®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Keywords: PK
Pharmacokinetics
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2008-09-09
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cmax of Proellex
timeFrame: Up to 72 hours post-dose
measure: AUC0-last of Proellex
timeFrame: Up to 72 hours post dose
measure: Tmax of Proellex
timeFrame: Up to 72 hours post dose
measure: AUC0-infinity of Proellex
timeFrame: Up to 72 hours post dose
measure: Terminal Elimination Half-life (T1/2) of Proellex
timeFrame: Up to 72 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Healthcare Discoveries Inc.
state: Texas
Study officials:
affiliation: Allergan
name: Anna Chan
role: STUDY_DIRECTOR
References: