Status:
COMPLETED
Crossover Study of the Safety and PK Properties of Proellex®
Lead Sponsor:
Repros Therapeutics Inc.
Conditions:
Pharmacokinetics
Eligibility:
FEMALE
18-34 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 11 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2008
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00749879
Start Date
August 11 2008
End Date
October 23 2008
Last Update
April 29 2019
Active Locations (1)
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1
Healthcare Discoveries Inc.
San Antonio, Texas, United States, 78229