Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies

Part of paid clinical trials in Orange, California.

Sponsor
Rigel Pharmaceuticals
Study ID
NCT07486713
Phase
PHASE4
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olutasidenib — DRUG
    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
  • CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Probe Substrates — DRUG
    Participants will receive a single dose of each probe substrate on Day 1 and Day 18.

Study Details

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.

Key Dates

Start date
Feb 23, 2026
Status verified
Mar 2026
Primary completion
Apr 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Olutasidenib, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Substrates
    Participants will receive olutasidenib twice daily from Day 5 to Day 22. Participant will also receive a single dose of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 probe substrates on Day 1 and Day 18.

Primary Outcome Measure

Area Under the Plasma Concentration-Time Curve (AUC) of Probe Drugs [ Time Frame: Up to 96 hours after each probe drug administration. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UCI Irvine HealthOrangeCalifornia92868-
New York Presbyterian Hospital-Columbia University Medical CenterNew YorkNew York10032-

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UCI Irvine Health· Orange, CANew York Presbyterian Hospital-Columbia University Medical Center· New York, NY

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