Phase 1
Completed N=12
Crossover Study of the Safety and PK Properties of Proellex®
Pharmacokinetics
Source: ClinicalTrials.gov NCT00749879 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Cmax of Proellex — 485.6; 876.7; 912.9; 1322.5 ng/mL
Summary
Study to evaluate the PK of 25 mg and 50 mg of Proellex from 2 different suppliers in the fed and fasting states.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax of Proellex |
485.6; 876.7; 912.9; 1322.5; 1346.7 | — |
| PRIMARY AUC0-last of Proellex |
6142.1; 5765.7; 11094.2; 9252.0; 9576.2 | — |
| PRIMARY Tmax of Proellex |
2.6; 0.8; 2.6; 0.9; 0.7 | — |
| PRIMARY AUC0-infinity of Proellex |
7039.8; 6897.0; 13014.9; 11271.6; 11804.8 | — |
| PRIMARY Terminal Elimination Half-life (T1/2) of Proellex |
22.1; 25.2; 23.8; 26.7; 27.5 | — |
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
Data sourced from ClinicalTrials.gov (NCT00749879). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.