Hepatic ImpairmentPhase 1NCT06425198
Study to Assess Drug Levels and Safety of BMS-986278 in Healthy Participants and Participants With Different Degrees of Hepatic Impairment
A Phase 1 study testing BMS-986278 in people with Hepatic Impairment and Healthy Participants, run by Bristol-Myers Squibb at 4 sites in United States.
Trial summary
The purpose of this study is to assess the drug levels and safety of BMS-986278 in participants with mild, moderate, and severe Hepatic Impairment (HI), and in matched healthy 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 Participants
- What is being tested?
- BMS-986278
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 4 sitesUnited States
- Study dates
- 10 Jun 2024to 30 Dec 2024
- 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
- All Participants:
- Must have a body mass index (BMI) between 18 and 40 kg/m^2 (inclusive), and body weight ≥ 50 kg.
- Mild, Moderate, or Severe Hepatic Impairment Participants:
- Mild, moderate, or severe hepatic impairment (HI) or cirrhosis due to chronic hepatic disease and/or prior alcohol use.
- Mild, moderate, and severe HI participants will be enrolled according to the Child-Pugh classification score.
- Matched Healthy Participants:
- Free of any clinically significant disease that would interfere with the study evaluations.
- Normal hepatic function participants will be enrolled and matched individually with HI participants with respect to age (± 10 years), weight (± 20%), sex, and race/ethnicity (Japanese and Chinese participants vs non-Japanese and non-Chinese participants).
Who cannot join
- All Participants:
- History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 7 units for women, or 14 units for men of alcohol per week (1 unit = 340 mL of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%).
- Must not have had any prior exposure to BMS-986278.
- Mild, Moderate, or Severe Hepatic Impairment Participants:
- Acute liver disease (eg, caused by an acute infection or drug toxicity).
- History of initial stage/planned liver transplantation within 6 months of screening or has received a liver transplant.
Show all 9Show fewer
- Matched Healthy Participants:
- Any significant medical condition, or psychiatric illness that would prevent participant from participating in the study.
- Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Local Institution - 0001
Miami Lakes, Florida, 33027
Local Institution - 0003
Orlando, Florida, 32809
Local Institution - 0004
San Antonio, Texas, 78215
Local Institution - 0002
Tampa, Florida, 33618
About this study
Official title: A Phase 1, Multi-center, Open-label Study to Assess the Pharmacokinetics and Safety of BMS-986278 in Healthy Participants and Those With Mild, Moderate and Severe Hepatic Impairment
The purpose of this study is to assess the drug levels and safety of BMS-986278 in participants with mild, moderate, and severe Hepatic Impairment (HI), and in matched healthy control participants with normal hepatic function.
- Conditions
- Hepatic Impairment, Healthy Participants
- Being tested
- BMS-986278
- Keywords
- Healthy Volunteers, Pharmacokinetics, Liver Diseases, Mild, Moderate and Severe Hepatic Impairment, BMS-986278
- Medical subject headings
- Liver Diseases, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986278Drug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Group A: Mild Hepatic Impairment BMS-986278 | Experimental | Not described Receives: Drug: BMS-986278 |
| Group B: Moderate Hepatic Impairment BMS-986278 | Experimental | Not described Receives: Drug: BMS-986278 |
| Group C: Severe Hepatic Impairment BMS-986278 | Experimental | Not described Receives: Drug: BMS-986278 |
| Group D: Normal Hepatic Function BMS-986278 | Experimental | Not described Receives: Drug: BMS-986278 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax)
Measured: Up to day 9
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Measured: Up to day 9
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Measured: Up to day 9
Secondary outcomes (12)
Incidence of adverse events (AEs)
Measured: Up to 62 days
Incidence of serious adverse events (SAEs)
Measured: Up to 62 days
Number of participants with physical examination abnormalities
Measured: Up to 62 days
Number of participants with vital sign abnormalities
Measured: Up to 62 days
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to 62 days
Number of participants with clinical laboratory abnormalities
Measured: Up to 62 days
Time of maximum observed concentration (Tmax)
Measured: Up to day 9
Terminal elimination half-life (T-HALF)
Measured: Up to day 9
Apparent body clearance (CLT/F)
Measured: Up to day 9
Maximum observed plasma concentration of unbound drug (Cmax_u)
Measured: Up to day 9
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration of unbound drug [AUC(0-T)_u]
Measured: Up to day 9
Area under the plasma concentration-time curve from time 0 extrapolated to infinite time of unbound drug [AUC(INF)_u]
Measured: Up to day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start10 Jun 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 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
- NCT06425198
- Sponsor's protocol ID
- IM027-1009
- Status last verified
- Jan 2025
- First submitted
- 17 May 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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/disclosurecommitment.html
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multi-center, Open-label Study to Assess the Pharmacokinetics and Safety of BMS-986278 in Healthy Participants and Those With Mild, Moderate and Severe Hepatic Impairment
- ClinicalTrials.gov ID
- NCT06425198
- Acronym / sponsor ID
- IM027-1009
- Conditions
- Hepatic Impairment, Healthy Participants
- Keywords
- Healthy Volunteers, Pharmacokinetics, Liver Diseases, Mild, Moderate and Severe Hepatic Impairment, BMS-986278
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 22 May 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 and safety of BMS-986278 in participants with mild, moderate, and severe Hepatic Impairment (HI), and in matched healthy control participants with normal hepatic function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A: Mild Hepatic Impairment BMS-986278 | Experimental | Drug: BMS-986278 |
| Group B: Moderate Hepatic Impairment BMS-986278 | Experimental | Drug: BMS-986278 |
| Group C: Severe Hepatic Impairment BMS-986278 | Experimental | Drug: BMS-986278 |
| Group D: Normal Hepatic Function BMS-986278 | Experimental | Drug: BMS-986278 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Must have a body mass index (BMI) between 18 and 40 kg/m^2 (inclusive), and body weight ≥ 50 kg.
- Mild, moderate, or severe hepatic impairment (HI) or cirrhosis due to chronic hepatic disease and/or prior alcohol use.
- Mild, moderate, and severe HI participants will be enrolled according to the Child-Pugh classification score.
- Free of any clinically significant disease that would interfere with the study evaluations.
- Normal hepatic function participants will be enrolled and matched individually with HI participants with respect to age (± 10 years), weight (± 20%), sex, and race/ethnicity (Japanese and Chinese participants vs non-Japanese and non-Chinese participants).
Key exclusion criteria (9 listed)
- History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 7 units for women, or 14 units for men of alcohol per week (1 unit = 340 mL of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%).
- Must not have had any prior exposure to BMS-986278.
- Acute liver disease (eg, caused by an acute infection or drug toxicity).
- History of initial stage/planned liver transplantation within 6 months of screening or has received a liver transplant.
- Any significant medical condition, or psychiatric illness that would prevent participant from participating in the study.
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 |
|---|---|---|
| BMS-986278Specified dose on specified days | Drug | Group A: Mild Hepatic Impairment BMS-986278, Group B: Moderate Hepatic Impairment BMS-986278, Group C: Severe Hepatic Impairment BMS-986278, Group D: Normal Hepatic Function BMS-986278 |
Primary outcome
Maximum observed concentration (Cmax)
Time frame: Up to day 9
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Time frame: Up to day 9
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Time frame: Up to day 9
12 secondary outcomes
Incidence of adverse events (AEs)
Time frame: Up to 62 days
Incidence of serious adverse events (SAEs)
Time frame: Up to 62 days
Number of participants with physical examination abnormalities
Time frame: Up to 62 days
Number of participants with vital sign abnormalities
Time frame: Up to 62 days
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 62 days
Number of participants with clinical laboratory abnormalities
Time frame: Up to 62 days
Time of maximum observed concentration (Tmax)
Time frame: Up to day 9
Terminal elimination half-life (T-HALF)
Time frame: Up to day 9
Apparent body clearance (CLT/F)
Time frame: Up to day 9
Maximum observed plasma concentration of unbound drug (Cmax_u)
Time frame: Up to day 9
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration of unbound drug [AUC(0-T)_u]
Time frame: Up to day 9
Area under the plasma concentration-time curve from time 0 extrapolated to infinite time of unbound drug [AUC(INF)_u]
Time frame: Up to day 9
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 22 Jan 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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/disclosurecommitment.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
4 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 BMS-986278 in people with Hepatic Impairment and Healthy Participants, run by Bristol-Myers Squibb at 4 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 8 inclusion and 9 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 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 concentration (Cmax) (time frame: Up to day 9). The study lists 3 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 22 Jan 2025.