Hepatic ImpairmentPhase 1NCT06352528
A Study to Assess the Drug Levels of Repotrectinib in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment
A Phase 1 study testing Repotrectinib in people with Hepatic Impairment and Healthy Volunteers, run by Bristol-Myers Squibb at 3 sites in United States.
Trial summary
The purpose of this study is to assess the drug levels of a single oral dose of repotrectinib in participants with moderate and severe HI, and in healthy matched control participants with normal hepatic function. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment, Healthy Volunteers
- What is being tested?
- Repotrectinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Apr 2024to 16 Sep 2025
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion Criteria for all Participants (Group 1, Group 2, Group 3):.
- Adult female (as assigned at birth) not of childbearing potential or male (as assigned at birth) of any race or ethnicity.
- Must have a body mass index between 18 and 40 kg/m2 (inclusive) and body weight ≥ 50 kg at the time of signing the ICF.
- Inclusion Criteria for Participants with Moderate or Severe Hepatic Impairment (Group 1 and Group 2):.
- Participants have moderate or severe HI or cirrhosis due to chronic hepatic disease and/or prior alcohol use.
- Participants have moderate (Group 1), or severe (Group 2) HI as defined by Child-Pugh score.
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- Inclusion Criteria for a Matched Healthy Participant (Group 3):.
- Participant must be free of any clinically significant disease that would interfere with the study evaluations.
- Participant must have liver-related laboratory test results within the respective reference ranges or with clinically insignificant excursions therefrom as agreed by the investigator.
- Participant must be in good health as determined by past medical history, physical examination, vital signs, ECG, and clinical laboratory safety tests. Clinical laboratory safety tests (eg, hematology, chemistry, and urinalysis) and 12-lead ECGs must be within normal limits or clinically acceptable as judged by the investigator.
Who cannot join
- Exclusion Criteria for all Participants (Group 1, Group 2, and Group 3):.
- Any major surgery within 4 weeks of the study intervention administration.
- History of drug abuse within 1 year of study intervention administration.
- History of alcohol abuse within 1 year of study intervention administration.
- Participants who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Panax Clinical Research
Miami Lakes, Florida, 33014-2811
Orlando Clinical Research Center
Orlando, Florida, 32809-3017
The Texas Liver Institute, Inc.
San Antonio, Texas, 78215
About this study
Official title: A Phase 1, Multicenter, Open-label, Single-dose Study to Assess the Pharmacokinetics of Repotrectinib in Healthy Participants and Those With Moderate and Severe Hepatic Impairment
The purpose of this study is to assess the drug levels of a single oral dose of repotrectinib in participants with moderate and severe HI, and in healthy matched control participants with normal hepatic function.
- Conditions
- Hepatic Impairment, Healthy Volunteers
- Being tested
- Repotrectinib
- Keywords
- Hepatic Impairment, Healthy Volunteers, Severe, BMS-986472, Repotrectinib, Liver Diseases, Pharmacokinetics
- Medical subject headings
- Lymphoma, Follicular, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RepotrectinibDrug
Also called BMS-986472
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Moderate Hepatic Impairment | Experimental | Not described Receives: Drug: Repotrectinib |
| Group 2: Severe Hepatic Impairment | Experimental | Not described Receives: Drug: Repotrectinib |
| Group 3: Normal Hepatic Function | Experimental | Not described Receives: Drug: Repotrectinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured: Days 1 to 11
Time of maximum observed plasma concentration (Tmax)
Measured: Days 1 to 11
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Measured: Days 1 to 11
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Measured: Days 1 to 11
Secondary outcomes (6)
Number of participants with Adverse Events (AEs)
Measured: Up to 28 days following last dose
Number of participants with Severe Adverse Events (SAEs)
Measured: Up to 28 days following last dose
Number of participants with physical examination abnormalities
Measured: Up to Day 11
Number of participants with vital sign abnormalities
Measured: Up to Day 11
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to Day 11
Number of participants with clinical safety laboratory test abnormalities
Measured: Up to Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start29 Apr 2024
- Primary completion16 Sep 2025
- Study completion16 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT06352528
- Sponsor's protocol ID
- CA127-1070
- Status last verified
- Sep 2025
- First submitted
- 3 Apr 2024
- Last updated
- 6 Oct 2025
- 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/disclosure-commitment.html
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-label, Single-dose Study to Assess the Pharmacokinetics of Repotrectinib in Healthy Participants and Those With Moderate and Severe Hepatic Impairment
- ClinicalTrials.gov ID
- NCT06352528
- Acronym / sponsor ID
- CA127-1070
- Conditions
- Hepatic Impairment, Healthy Volunteers
- Keywords
- Hepatic Impairment, Healthy Volunteers, Severe, BMS-986472, Repotrectinib, Liver Diseases, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 16 Sep 2025 (actual)
- Study completion
- 16 Sep 2025 (actual)
- First posted
- 8 Apr 2024 (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 this study is to assess the drug levels of a single oral dose of repotrectinib in participants with moderate and severe HI, and in healthy matched control participants with normal hepatic function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Moderate Hepatic Impairment | Experimental | Drug: Repotrectinib |
| Group 2: Severe Hepatic Impairment | Experimental | Drug: Repotrectinib |
| Group 3: Normal Hepatic Function | Experimental | Drug: Repotrectinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Inclusion Criteria for all Participants (Group 1, Group 2, Group 3):.
- Adult female (as assigned at birth) not of childbearing potential or male (as assigned at birth) of any race or ethnicity.
- Must have a body mass index between 18 and 40 kg/m2 (inclusive) and body weight ≥ 50 kg at the time of signing the ICF.
- Inclusion Criteria for Participants with Moderate or Severe Hepatic Impairment (Group 1 and Group 2):.
- Participants have moderate or severe HI or cirrhosis due to chronic hepatic disease and/or prior alcohol use.
Key exclusion criteria (6 listed)
- Exclusion Criteria for all Participants (Group 1, Group 2, and Group 3):.
- Any major surgery within 4 weeks of the study intervention administration.
- History of drug abuse within 1 year of study intervention administration.
- History of alcohol abuse within 1 year of study intervention administration.
- Participants who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1.
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 |
|---|---|---|
| RepotrectinibAlso: BMS-986472Specified dose on specified days | Drug | Group 1: Moderate Hepatic Impairment, Group 2: Severe Hepatic Impairment, Group 3: Normal Hepatic Function |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Days 1 to 11
Time of maximum observed plasma concentration (Tmax)
Time frame: Days 1 to 11
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Days 1 to 11
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Days 1 to 11
6 secondary outcomes
Number of participants with Adverse Events (AEs)
Time frame: Up to 28 days following last dose
Number of participants with Severe Adverse Events (SAEs)
Time frame: Up to 28 days following last dose
Number of participants with physical examination abnormalities
Time frame: Up to Day 11
Number of participants with vital sign abnormalities
Time frame: Up to Day 11
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to Day 11
Number of participants with clinical safety laboratory test abnormalities
Time frame: Up to Day 11
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 6 Oct 2025.
- 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/disclosure-commitment.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
3 sites 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 in people with Hepatic Impairment and Healthy Volunteers, run by Bristol-Myers Squibb at 3 sites 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 10 inclusion and 6 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 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Maximum observed plasma concentration (Cmax) (time frame: Days 1 to 11). The study lists 4 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 6 Oct 2025.