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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.
Recruitment on hold