RecruitingPhase 4NCT07704658

Pralsetinib DDI Study in Patients With Advanced or Metastatic Solid Tumors

A Multi-center, Open-label, Drug-drug Interaction Study to Evaluate the Effect of Pralsetinib (Gavreto) on the Pharmacokinetics of CYP3A4, CYP2C8, and CYP2C9 Substrates, and Hormones Estradiol/Norethisterone Acetate in Patients With Advanced or Metastatic Solid Tumors

Sponsor

Rigel Pharmaceuticals

Enrollment

12 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Thyroid Cancer NSCLC (Non-small Cell Lung Cancer)Advanced Malignancies Solid Tumor Malignancies

Summary

An open-label drug-drug interaction study to evaluate the effects of pralsetinib (Gavreto) on the pharmacokinetics of a CYP450 probe substrate cocktail and, in female participants, a hormonal probe substrate, in participants with rearranged during transfection (RET) fusion- or mutation-positive solid tumors

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called CYP3A4, CYP2C8, and CYP2C9 substrates, and hormonal contraceptive and a drug called Pralsetinib for people with advanced malignancies, nsclc (non-small cell lung cancer), 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

DRUGPralsetinib

Pralsetinib 400mg orally (PO) once daily (QD) from Day 4 to Day 10, with an option to continue up to Day 33

DRUGCYP3A4, CYP2C8, and CYP2C9 substrates, and hormonal contraceptive

Midazolam, repaglinide, and losartan (CYP probe substrates) and, for female participants, estradiol/norethisterone acetate (hormonal probe substrate), administered orally (PO) once on Day 1 and once on Day 9.