Conditions: Healthy
Keywords: Pharmacokinetics
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 25
Healthy volunteers: yes

Brief summary:
Dose escalating study of 7 daily doses of Proellex at 100 mg, 150 mg and 200 mg

Detailed description:
This is an open-label, single-center, outpatient, unblinded, multi-dose study of the safety and pharmacokinetic properties of Proellex®. Six female subjects will each receive seven daily doses of Proellex® in separate, rising doses. Dosing must be accomplished between menstrual periods. The first six women will complete the 100 mg visit schedule before the next six women will begin the 150 mg visit schedule. Blood will be collected at pre-dose, and at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 5, 8, 12, 24 and 36 (Day 7 only) hrs post-dose on Day 1 and Day 7. Subjects will be allowed to leave the clinic between the 12 and 24 hr and the 24 and 36 hr PK blood draws. Subjects will be discharged from the study after a one month follow-up visit. Safety will be assessed throughout the study.

Arms:
arm 1: Proellex 100 mg daily for 7 days arm 2: Proellex 150 mg daily for 7 days arm 3: Proellex 200 mg daily for 7 days

Interventions: intervention 1: Proellex
Intervention descriptions: intervention 1: Proellex 25 mg capsules 100 mg, 150 mg or 200mg daily for 7 days

Protocol document: