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Pralsetinib DDI Study in Patients With Advanced or Metastatic Solid Tumors

NCT07704658 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-08-10

No results posted yet for this study

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

Conditions

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

Interventions

DRUG

Pralsetinib

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

DRUG

CYP3A4, 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.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-04
Primary Completion
2027-07-30
Completion
2027-08-30
FDA Drug
Yes

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07704658 on ClinicalTrials.gov