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Phase 1 Completed N=12 Randomized Basic Science

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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