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A Phase 1, 2-Part, Multicenter, Open-label, 3-Arm Study to Determine the Effect of Enasidenib (CC-90007) on the Pharmacokinetics of Single Doses of Caffeine, Dextromethorphan, Flurbiprofen, Midazolam, Omeprazole, Digoxin, Rosuvastatin, and Pioglitazone in Subjects With Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation
In this trial, patients can only be entered into one treatment arm. Different probes will be administered, depending on the allocated Arm. Probes in Arm 1 of the study will consist of single doses of caffeine (100mg), dextromethorphan (30 mg), flurbiprofen (50 mg), midazolam (0.03 mg/kg), and omeprazole (40 mg). In Arm 2, probes include digoxin (0.25 mg), and rosuvastatin (10 mg). Arm 3 contains a single probe, pioglitazone (15 mg). In all Arms of the study, Enasidenib will be administered orally. All probes, except midazolam, will also be administered orally. Midazolam will be administered intravenously.