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This phase I study ( CO ‐338‐044;  NCT 02740712), conducted in patients with advanced solid tumors, evaluated the effect of the poly( ADP ‐ribose) polymerase (PARP) inhibitor rucaparib on the pharmacokinetics (PK) of caffeine 200 mg, warfarin 10 mg, omeprazole 40 mg, and midazolam 2 mg (cytochrome P450 ( CYP ) 1A2,  CYP 2C9,  CYP 2C19, and  CYP 3A substrates; dosed as a cocktail) and digoxin 0.25 mg (P‐glycoprotein (P‐gp) substrate; dosed separately) without rucaparib and following oral rucaparib 600 mg b.i.d. Geometric mean ( GM ) ratios (90% confidence interval ( CI )) of area under the concentration‐time curve ( AUC ) from time zero to last quantifiable measurement with and without rucaparib were: caffeine, 2.26 (1.93–2.65); S‐warfarin, 1.49 (1.40–1.58); omeprazole, 1.55 (1.32–1.83); midazolam, 1.39 (1.14–1.68); and digoxin, 1.20 (1.12–1.29). There was limited effect on peak concentration of the substrates ( GM  ratios, 0.99–1.13). At steady state, rucaparib 600 mg b.i.d. moderately inhibited  CYP 1A2, weakly inhibited  CYP 2C9,  CYP 2C19, and  CYP 3A, and marginally increased digoxin exposure.

clinical and translational science

Evaluation of Drug–Drug Interactions of Rucaparib and  CYP 1A2,  CYP 2C9,  CYP 2C19,  CYP 3A, and P‐gp Substrates in Patients With an Advanced Solid Tumor