Conditions: Drug Interactions
Keywords: Drug-drug interactions DDI
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 18
Healthy volunteers: yes

Brief summary:
This study will assess possible drug-drug interactions with specific isoenzymes over a total study duration of 6-8 weeks. Blood samples collected pre and post-dose, and urine samples collected post dose will be analyzed.

Detailed description:
This is an open-label, multiple-dose, non-randomized study to assess the drug-drug interactions of Proellex® with cytochrome P450 isoenzymes in healthy female subjects. On Day 1, following an overnight fast and morning void of the bladder, subjects will be administered CYP probe drugs orally. Serial blood samples will be collected at pre-dose and post-dose. Subjects will be administered two Proellex® 25 mg capsules (50 mg total dose) at approximately 0800 hours on Day 2 and 0700 hours on Days 3 through 8. One hour after administration of Proellex® on Day 8, the five CYP probe drugs will be administered and blood and urine samples collected as on Day 1. Blood samples for the determination of plasma concentrations of CDB-4124 and its metabolite CDB-4453 will be collected at pre-dose (trough) on Days 6, 7, and 8 to determine if steady-state conditions have been achieved. Samples will also be collected on Day 8 at 1, 2, 8 and 24 hour after administration of Proellex® to determine the plasma concentrations of CDB-4124 and CDB-4453.

Arms:
arm 1: Proellex 50 mg CYP1A2 probe CYP2C9 probe CYP2C19 probe CYP2D6 probe CYP3A4 probe

Interventions: intervention 1: Proellex intervention 2: CYP1A2 probe intervention 3: CYP2C9 probe intervention 4: CYP2C19 probe intervention 5: CYP2D6 probe intervention 6: CYP3A4 probe
Intervention descriptions: intervention 1: 2, 25 mg Proellex capsules administered daily intervention 2: Caffeine (200 mg) intervention 3: Tolbutamide (250 mg) intervention 4: Omeprazole (20 mg) intervention 5: Dextromethorphan (30 mg) intervention 6: Midazolam (2mg)

Protocol document: