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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
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jun 24, 2026
Report code
NCT07486713-Jun 24, 2026
NCT ID
NCT07486713
Status
RECRUITING
Phase
Phase 4
Sponsor
Rigel Pharmaceuticals
Executive brief
Investment-Ready Snapshot
Rigel Pharmaceuticals is conducting a Phase 4 open-label drug-drug interaction study to evaluate olutasidenib's impact on the pharmacokinetics of various CYP450 enzymes and the OATP1B1 transporter in patients with IDH1 mutation-positive malignancies. The study targets a niche market of patients with specific malignancies, including acute myeloid leukemia (AML) and gliomas, which may enhance the therapeutic profile of olutasidenib. Given the increasing focus on personalized medicine and targeted therapies, successful outcomes could strengthen Rigel's market position and expand olutasidenib's clinical utility. The competitive landscape includes other IDH1 inhibitors and therapies for AML and gliomas, necessitating a robust differentiation strategy based on pharmacokinetic profiles and safety data. Diligence implications include assessing the potential for combination therapies and the impact of drug-drug interactions on treatment regimens.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT07486713
Indication
AML (Acute Myeloid Leukemia)
Modality
small molecule
Target
CYP450 enzymes (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4) and OATP1B1 transporter.
Intervention
Olutasidenib, CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4, and OATP1B1 Probe Substrates
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.