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midazolam + warfarin + vitamin K + omeprazole + fexofenadine
- Development stage
- Unknown
- Lead developer
- Johnson & Johnson
- Modality
- Small Molecules
- Administration
- Oral
01
Overview
This drug cocktail is a combination of five probe substrates—midazolam, warfarin, vitamin K, omeprazole, and fexofenadine—used in a Phase 1 clinical trial (NCT02492126) sponsored by Aragon Pharmaceuticals (a subsidiary of Johnson & Johnson). The study was designed to evaluate the drug-drug interaction (DDI) potential of apalutamide (JNJ-56021927) in patients with castration-resistant prostate cancer. Each component of the cocktail serves as a specific substrate for metabolic enzymes or transporters: midazolam for CYP3A4, warfarin for CYP2C9, omeprazole for CYP2C19, and fexofenadine for P-glycoprotein (P-gp). Vitamin K is included to ensure safety during warfarin administration. By measuring the pharmacokinetics of these substrates before and after apalutamide treatment, researchers can determine if apalutamide acts as a metabolic inducer or inhibitor of these key pathways.
- Other names
- drug cocktail-Aragon Pharmaceuticals, Inc.-prostate cancer (castration-resistant)Aragon DDI CocktailApalutamide DDI Probe Cocktail
02
Targets
CYP3A4 (Cytochrome P450 3A4)GABRR (GABA-A receptor subunit rho)VKORC1 (Vitamin K epoxide reductase complex subunit 1)
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