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

NCT ID: NCT07223671

Last Updated: 2026-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-03-19

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

Group Type EXPERIMENTAL

Repotrectinib

Intervention Type DRUG

Specified dose on specified days

Metformin

Intervention Type DRUG

Specified dose on specified days

Digoxin

Intervention Type DRUG

Specified dose on specified days

Rosuvastatin

Intervention Type DRUG

Specified dose on specified days

Cohort 2

Group Type EXPERIMENTAL

Repotrectinib

Intervention Type DRUG

Specified dose on specified days

Bupropion

Intervention Type DRUG

Specified dose on specified days

Flurbiprofen

Intervention Type DRUG

Specified dose on specified days

Omeprazole

Intervention Type DRUG

Specified dose on specified days

Interventions

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Repotrectinib

Specified dose on specified days

Intervention Type DRUG

Metformin

Specified dose on specified days

Intervention Type DRUG

Digoxin

Specified dose on specified days

Intervention Type DRUG

Rosuvastatin

Specified dose on specified days

Intervention Type DRUG

Bupropion

Specified dose on specified days

Intervention Type DRUG

Flurbiprofen

Specified dose on specified days

Intervention Type DRUG

Omeprazole

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Fortrea Clinical Research Unit - Daytona Beach

Daytona Beach, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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BMS Clinical Trials Contact Centre www.BMSClinicalTrials.com

Role: CONTACT

[email protected]
855-907-3286

First line of the email MUST contain and Site #.

Role: CONTACT

Facility Contacts

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Chiamaka Iheme, Site 0001

Role: primary

386-366-6469

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

Other Identifiers

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CA127-1088

Identifier Type: -

Identifier Source: org_study_id

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