NCT07486713

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Rigel Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• AML (Acute Myeloid Leukemia)
• Glioma
• Cholangiocarcinoma
• Solid Tumor Malignancies

Interventions

Type	Name	Description
DRUG	Olutasidenib	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
DRUG	CYP1A2, 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.

Timeline

• Start date: 2026-02-23
• Primary completion: 2027-04-30
• Completion: 2027-06-30
• First posted: 2026-03-20
• Last updated: 2026-03-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study