Dose escalating study of 7 daily doses of Proellex at 100 mg, 150 mg and 200 mg
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Proellex 25 mg capsules 100 mg, 150 mg or 200mg daily for 7 days
Healthcare Discoveries Inc.
San Antonio, Texas, United States
Cmax Post Final Dose
To determine the safety and PK properties of 100 mg, 150 mg and 200 mg of Proellex® taken for seven days by healthy adult female subjects.
Time frame: 7 days
AUC Post Final Dose
Time frame: 7 days
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