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

Bristol-Myers Squibb30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

RepotrectinibDRUG

Specified dose on specified days

MetforminDRUG

Specified dose on specified days

DigoxinDRUG

Specified dose on specified days

Rosuvastatin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria * Participants must have a body mass index (BMI) of 18.0 to 32.0 kg/m2 and should be between the ages of 18-60 years inclusive. * Healthy female (as assigned at birth) participants who are individuals not of childbearing potential (INOCBP) and healthy males with no clinically significant deviation from normal for the following: medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessment results as determined by the investigator. Exclusion Criteria * Participants must not have a significant history of clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, psychiatric, neoplastic, or genitourinary abnormalities/diseases as determined by the investigator or designee. * Other protocol-defined Inclusion/Exclusion criteria apply.

Locations (1)

Local Institution - 0001

Daytona Beach, Florida, United States

Outcomes

Primary Outcomes

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

Probe substrate contains metformin, digoxin, and rosuvastatin.

Time frame: Up to approximately Day 17 post dose

Cohort 1: AUC (0-T) of Probe Substrate Without Repotrectinib

Probe substrate contains metformin, digoxin, and rosuvastatin.

Time frame: Up to approximately Day 17 post dose

Cohort 1: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of Probe Substrate With Repotrectinib

Probe substrate contains metformin, digoxin, and rosuvastatin.

Time frame: Up to approximately Day 17 post dose

Cohort 1: AUC(INF) of Probe Substrate Without Repotrectinib

Probe substrate contains metformin, digoxin, and rosuvastatin.

Time frame: Up to approximately Day 17 post dose

Cohort 1: Maximum Observed Plasma Concentration (Cmax) of Probe Substrate With Repotrectinib

Probe substrate contains metformin, digoxin, and rosuvastatin

Time frame: Up to approximately Day 17 post dose

Cohort 1: Cmax of Probe Substrate Without Repotrectinib

Probe substrate contains metformin, digoxin, and rosuvastatin

Time frame: Up to approximately Day 17 post dose

Cohort 1: Area Under the Plasma Concentration-time Curve From Time Zero to 48 Hours Post Dose (AUC (0-48)) of Metformin With Repotrectinib

Time frame: Up to approximately Day 17 post dose

Data from ClinicalTrials.gov

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Specified dose on specified days

BupropionDRUG

Specified dose on specified days

FlurbiprofenDRUG

Specified dose on specified days

OmeprazoleDRUG

Specified dose on specified days

Cohort 1: AUC (0-48) of Metformin Without Repotrectinib

Time frame: Up to approximately Day 17 post dose

Cohort 1: Renal Clearance (CLR) of Metformin in Urine

Time frame: Up to approximately Day 16 post dose

Cohort 2: AUC (0-T) of Probe Substrate With Repotrectinib

Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)

Time frame: Up to approximately Day 17 post dose

Cohort 2: AUC (0-T) of Probe Substrate Without Repotrectinib

Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)

Time frame: Up to approximately Day 17 post dose

Cohort 2: AUC (INF) of Probe Substrate With Repotrectinib

Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)

Time frame: Up to approximately Day 17 post dose

Cohort 2: AUC (INF) of Probe Substrate Without Repotrectinib

Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)

Time frame: Up to approximately Day 17 post dose

Cohort 2: Cmax of Probe Substrate With Repotrectinib

Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)

Time frame: Up to approximately Day 17 post dose

Cohort 2: Cmax of Probe Substrate Without Repotrectinib

Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)

Time frame: Up to approximately Day 17 post dose

Secondary Outcomes

Number of Participants with Adverse Events (AEs)

Time frame: Up to approximately Day 45 post dose

Number of Participants with Serious Adverse Events (SAEs)

Time frame: Up to approximately Day 45 post dose

Number of Participants With Clinically Significant Physical Examination Findings

Time frame: Up to approximately Day 17 post dose

Number of Participants With Clinically Significant Vital Sign Measurements

Time frame: Up to approximately Day 17 post dose

Number of Participants With Clinically Significant 12-lead Electrocardiogram (12-lead ECG) Findings

Time frame: Up to approximately Day 17 post dose

Number of Participants With Clinically Significant Safety Laboratory Test Results

Time frame: Up to approximately Day 17 post dose