RecruitingPhase 4NCT07486713

Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies

A Multi-Center, Open-Label, Drug-Drug Interaction Study to Evaluate the Effect of Olutasidenib on the Pharmacokinetics of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Substrates in Patients With IDH1 Mutation-Positive Malignancies Being Treated With Olutasidenib

Sponsor

Rigel Pharmaceuticals

Enrollment

16 participants

Start Date

Feb 23, 2026

Study Type

INTERVENTIONAL

Conditions

Cholangiocarcinoma Solid Tumor Malignancies Glioma AML (Acute Myeloid Leukemia)

Summary

A open-label drug-drug interaction (DDI) study to evaluate the effects of olutasidenib on the pharmacokinetics (PK) of a CYP450 and OATP1B1 probe substrate cocktail in participants with IDH1 mutation-positive malignancies.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Probe Substrates and a drug called Olutasidenib for people with aml (acute myeloid leukemia), cholangiocarcinoma, and other related conditions. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOlutasidenib

Participants will receive repeated dosing of olutasidenib from Day 5 to Day 22 until steady state, with an option to continue treatment up to Day 64

DRUGCYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Probe Substrates

Participants will receive a single dose of each probe substrate on Day 1 and Day 18.

Locations(2)

UCI Irvine Health

Orange, California, United States

New York Presbyterian Hospital-Columbia University Medical Center

New York, New York, United States

View Full Details on ClinicalTrials.gov

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NCT07486713

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