Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants

Part of paid clinical trials in Daytona Beach, Florida.

Sponsor
Bristol-Myers Squibb
Study ID
NCT07223671
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Repotrectinib — DRUG
    Specified dose on specified days
  • Metformin — DRUG
    Specified dose on specified days
  • Digoxin — DRUG
    Specified dose on specified days
  • Rosuvastatin — DRUG
    Specified dose on specified days
  • Bupropion — DRUG
    Specified dose on specified days
  • Flurbiprofen — DRUG
    Specified dose on specified days
  • Omeprazole — DRUG
    Specified dose on specified days

Study Details

The purpose of the study if to evaluate the effect of Repotrectinib on the drug levels of transporter and CYP P450 probe substrates in healthy adult participants.

Key Dates

Start date
Dec 31, 2025
Status verified
Mar 2026
Primary completion
Feb 19, 2026
Completion
Mar 19, 2026

Study Design

Enrollment
30 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
  • Experimental: Cohort 2

Primary Outcome Measure

Cohort 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration of AUC (0-T) of Probe Substrate With Repotrectinib [ Time Frame: Up to approximately Day 17 post dose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Local Institution - 0001Daytona BeachFlorida32117-5116-

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Local Institution - 0001· Daytona Beach, FL

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