Conditions: Healthy
Keywords: PK Pharmacokinetics
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 12
Healthy volunteers: yes

Brief 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.

Detailed description:
This is 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. Twelve female subjects will each receive a single dose of Proellex®: 25 mg (fed state, formulation A), 25 mg (fed state, formulation B), and 25 mg (fasting state, formulation B); successive dosing will be separated by at least one week intervals from the previous dosing. Blood will be collected prior to taking the dose, and following the dose for 24 hours post-dose. Subjects will be discharged from the study after the last blood sample is obtained after the third dose of Proellex®. Safety will be assessed throughout the study.

Arms:
arm 1: Single dose of Proellex 25 mg formulation A, fed arm 2: Single dose of Proellex 25 mg formulation B, fed arm 3: Single dose of Proellex 25 mg formulation B, fasted

Interventions: intervention 1: Proellex 25 mg formulation A intervention 2: Proellex 25 mg formulation B
Intervention descriptions: intervention 1: One Proellex 25 mg formulation A capsule intervention 2: One 25 mg Proellex capsule formulation B administered both fed and fasted

Protocol document: