Proellex® Pharmacokinetic Bridging Study II
Condition: Healthy
Intervention: Proellex 25 mg formulation A; Proellex 25 mg formulation B
Intervention description: One Proellex 25 mg formulation A capsule; One 25 mg Proellex capsule formulation B administered both fed and fasted
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Female
Minimum age: 18 Years
Maximum age: 34 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: PK; Pharmacokinetics

Summary:

      An open-label, randomized, single-center, outpatient, unblinded, single-dose, three-way
      crossover study of the safety and PK properties of Proellex® in women ages 18 - 34 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must be able to speak, read and understand English and be willing and able to
             provide written informed consent on an Institutional Review Board (IRB)-approved form
             prior to the initiation of any study procedures. Subject must have signed and dated a
             written Informed Consent Form (ICF) before undergoing any study related activities,
             including discontinuation of any prohibited medications

          -  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

          -  In general good health

          -  Must have agreed to not attempt to become pregnant at any time during study
             participation or for 30 days thereafter

          -  Must not have used tobacco (nicotine products) for at least two years before the study
             starts

          -  Must have normal (or abnormal and clinically insignificant) laboratory values at
             screening

          -  Willing to remain in the clinic for the screening visit and for the treatment visits

          -  Available for all treatment and follow-up visits

          -  Willing to comply with all study procedures

          -  Additional inclusion criteria may apply

        Exclusion Criteria:

          -  Pregnant or lactating females or women who are attempting or expecting to become
             pregnant at any time during the study

          -  Past or present history of experiencing any allergic reaction to the formulations
             administered in this study, or in the opinion of the Principal Investigator, suggests
             an increased potential for an adverse hypersensitivity

          -  Any medical condition, which, in the judgment of the Principal Investigator, will
             prevent the subject from starting and/or completing the study

          -  Past or present history of any significant cardiovascular, renal, hepatic disease,
             thrombophlebitis, thromboembolic disorders, or cerebrovascular accident requiring
             ongoing medical therapy or clinical intervention

          -  A QTc interval of >450ms at screening

          -  Subject with abnormal screening visit vital signs or clinical laboratory evaluation
             considered clinically significant by the Principal Investigator

          -  Subjects with symptomatic uterine fibroids or endometriosis

          -  Use of other oral contraceptives or hormonal treatments within 30 days of first dose
             of study medication

          -  Use of a hormone-releasing intrauterine device

          -  Subject with a history of alcohol and/or drug abuse

          -  Known active infection of HIV, Hepatitis A, B or C

          -  Subject who has participated in a clinical trial with investigational medication
             within 30 days prior to study medication administration or who plans to take an
             experimental drug prior to the end of 30 days after participation in this study