Study of Olutasidenib Effects on Drug Metabolism in Adults With IDH1 Mutation-Positive Cancers

What this Trial Is About

Researchers are evaluating the effects of olutasidenib on the pharmacokinetics of several CYP450 and OATP1B1 probe substrates in people with IDH1 mutation-positive cancers, including acute myeloid leukemia, glioma, cholangiocarcinoma, and other solid tumors. This open-label, phase 4 study aims to understand how olutasidenib interacts with these enzymes and transporters when given to affected patients. Participants will receive a single dose of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 probe substrates on Day 1 and Day 18. They will also take olutasidenib twice daily from Day 5 to Day 22 to reach steady state, with an option to continue treatment up to Day 64. The study involves no placebo group and monitors the drug interactions during this treatment period. During the study, participants will undergo blood sampling up to 96 hours after each probe drug dose to measure plasma concentrations and other pharmacokinetic parameters. Researchers will track the area under the curve, maximum concentration, time to maximum concentration, elimination half-life, and clearance of the probe drugs. Safety monitoring includes recording treatment-emergent adverse events from the start of treatment through about 30 days after the last dose. The study is expected to complete in mid-2027.

Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies