Healthy VolunteersPhase 1NCT07223671
Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants
A Phase 1 study testing Repotrectinib, Metformin and Digoxin in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Repotrectinib, Metformin and Digoxin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2025to 19 Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Local Institution - 0001
Daytona Beach, Florida, 32117-5116
About this study
Official title: Phase 1, 2-Cohort, Open-label, Fixed-sequence, Drug-drug Interaction Study to Evaluate the Effect of Repotrectinib on the Pharmacokinetics of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants
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.
- Conditions
- Healthy Volunteers
- Being tested
- Repotrectinib, Metformin, Digoxin, Rosuvastatin, Bupropion
- Keywords
- Drug-Drug Interactions, Pharmacokinetics, Transporter Probe Substrates, CYP P450 Probe Substrates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RepotrectinibDrug
Specified dose on specified days
MetforminDrug
Specified dose on specified days
DigoxinDrug
Specified dose on specified days
RosuvastatinDrug
Specified dose on specified days
BupropionDrug
Specified dose on specified days
FlurbiprofenDrug
Specified dose on specified days
OmeprazoleDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Not described Receives: Drug: Repotrectinib; Drug: Metformin; Drug: Digoxin; Drug: Rosuvastatin |
| Cohort 2 | Experimental | Not described Receives: Drug: Repotrectinib; Drug: Bupropion; Drug: Flurbiprofen; Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately Day 17 post dose
Cohort 1: AUC (0-T) of Probe Substrate Without Repotrectinib
Probe substrate contains metformin, digoxin, and rosuvastatin.
Measured: 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.
Measured: Up to approximately Day 17 post dose
Cohort 1: AUC(INF) of Probe Substrate Without Repotrectinib
Probe substrate contains metformin, digoxin, and rosuvastatin.
Measured: 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
Measured: Up to approximately Day 17 post dose
Cohort 1: Cmax of Probe Substrate Without Repotrectinib
Probe substrate contains metformin, digoxin, and rosuvastatin
Measured: 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
Measured: Up to approximately Day 17 post dose
Cohort 1: AUC (0-48) of Metformin Without Repotrectinib
Measured: Up to approximately Day 17 post dose
Cohort 1: Renal Clearance (CLR) of Metformin in Urine
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Up to approximately Day 17 post dose
Secondary outcomes (6)
Number of Participants with Adverse Events (AEs)
Measured: Up to approximately Day 45 post dose
Number of Participants with Serious Adverse Events (SAEs)
Measured: Up to approximately Day 45 post dose
Number of Participants With Clinically Significant Physical Examination Findings
Measured: Up to approximately Day 17 post dose
Number of Participants With Clinically Significant Vital Sign Measurements
Measured: Up to approximately Day 17 post dose
Number of Participants With Clinically Significant 12-lead Electrocardiogram (12-lead ECG) Findings
Measured: Up to approximately Day 17 post dose
Number of Participants With Clinically Significant Safety Laboratory Test Results
Measured: Up to approximately Day 17 post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2025
- Study start31 Dec 2025
- Primary completion19 Feb 2026
- Study completion19 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07223671
- Sponsor's protocol ID
- CA127-1088
- Status last verified
- Mar 2026
- First submitted
- 30 Oct 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, 2-Cohort, Open-label, Fixed-sequence, Drug-drug Interaction Study to Evaluate the Effect of Repotrectinib on the Pharmacokinetics of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07223671
- Acronym / sponsor ID
- CA127-1088
- Conditions
- Healthy Volunteers
- Keywords
- Drug-Drug Interactions, Pharmacokinetics, Transporter Probe Substrates, CYP P450 Probe Substrates
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2025 (actual)
- Primary completion
- 19 Feb 2026 (actual)
- Study completion
- 19 Mar 2026 (actual)
- First posted
- 3 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Repotrectinib, Drug: Metformin, Drug: Digoxin, Drug: Rosuvastatin |
| Cohort 2 | Experimental | Drug: Repotrectinib, Drug: Bupropion, Drug: Flurbiprofen, Drug: Omeprazole |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RepotrectinibSpecified dose on specified days | Drug | Cohort 1, Cohort 2 |
| MetforminSpecified dose on specified days | Drug | Cohort 1 |
| DigoxinSpecified dose on specified days | Drug | Cohort 1 |
| RosuvastatinSpecified dose on specified days | Drug | Cohort 1 |
| BupropionSpecified dose on specified days | Drug | Cohort 2 |
| FlurbiprofenSpecified dose on specified days | Drug | Cohort 2 |
| OmeprazoleSpecified dose on specified days | Drug | Cohort 2 |
Primary outcome
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
Probe substrate contains metformin, digoxin, and rosuvastatin.
Cohort 1: AUC (0-T) of Probe Substrate Without Repotrectinib
Time frame: Up to approximately Day 17 post dose
Probe substrate contains metformin, digoxin, and rosuvastatin.
Cohort 1: Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of Probe Substrate With Repotrectinib
Time frame: Up to approximately Day 17 post dose
Probe substrate contains metformin, digoxin, and rosuvastatin.
Cohort 1: AUC(INF) of Probe Substrate Without Repotrectinib
Time frame: Up to approximately Day 17 post dose
Probe substrate contains metformin, digoxin, and rosuvastatin.
Cohort 1: Maximum Observed Plasma Concentration (Cmax) of Probe Substrate With Repotrectinib
Time frame: Up to approximately Day 17 post dose
Probe substrate contains metformin, digoxin, and rosuvastatin
Cohort 1: Cmax of Probe Substrate Without Repotrectinib
Time frame: Up to approximately Day 17 post dose
Probe substrate contains metformin, digoxin, and rosuvastatin
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
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
Time frame: Up to approximately Day 17 post dose
Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)
Cohort 2: AUC (0-T) of Probe Substrate Without Repotrectinib
Time frame: Up to approximately Day 17 post dose
Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)
Cohort 2: AUC (INF) of Probe Substrate With Repotrectinib
Time frame: Up to approximately Day 17 post dose
Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)
Cohort 2: AUC (INF) of Probe Substrate Without Repotrectinib
Time frame: Up to approximately Day 17 post dose
Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)
Cohort 2: Cmax of Probe Substrate With Repotrectinib
Time frame: Up to approximately Day 17 post dose
Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)
Cohort 2: Cmax of Probe Substrate Without Repotrectinib
Time frame: Up to approximately Day 17 post dose
Probe substrate contains bupropion, hydroxybupropion, flurbiprofen, 4'-hydroxyflurbiprofen, omeprazole, 5'- hydroxyomeprazole)
6 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Repotrectinib, Metformin and Digoxin in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.