Pralsetinib DDI Study in Patients With Advanced or Metastatic Solid Tumors

Sponsor
Rigel Pharmaceuticals
Study ID
NCT07704658
Phase
PHASE4
Status
Recruiting
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Conditions

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

Eligibility Criteria

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

Interventions

  • Pralsetinib — DRUG
    Pralsetinib 400mg orally (PO) once daily (QD) from Day 4 to Day 10, with an option to continue up to Day 33
  • CYP3A4, CYP2C8, and CYP2C9 substrates, and hormonal contraceptive — DRUG
    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.

Study Details

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

Key Dates

First listed
Jul 15, 2026
Start date
Jun 30, 2026
Status verified
Jul 2026
Primary completion
Jul 30, 2027
Completion
Aug 30, 2027

Study Design

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

Arms

  • Experimental: Pralsetinib with CYP450 Probe Substrates and Hormonal Contraceptive

Primary Outcome Measure

Area Under the Plasma Concentration-Time Curve from zero to infinity (AUC0-inf) [ Time Frame: Up to 48 hours post-dose or as appropriate for each probe substrate ]

Central Contacts

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