Healthy VolunteersPhase 1NCT06746402
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of BMS-986278 and the Effects of BMS-986278 on Cardiac Repolarization in Healthy Participants
A Phase 1 study testing BMS-986278 and Moxifloxacin in people with Healthy Volunteers, run by Bristol-Myers Squibb at 2 sites in United States.
Trial summary
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics (PK) of high dose of BMS-986278 in healthy participants and to assess the effect of BMS-986278 on the ECG intervals in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BMS-986278 and Moxifloxacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Feb 2025to 11 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female individuals not of childbearing potential (INOCBP) and males.
- Healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments.
- Body mass index (BMI) 18.0 to 32.0 kg/m2 , inclusive, for Parts A and B.
Who cannot join
- Any significant acute or chronic medical illness as determined by the investigator.
- History of clinically relevant cardiac disease as determined by the investigator, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for ventricular arrhythmias.
- Any significant history of disease of the cardiovascular system that in the opinion of the Investigator makes the participant unsuitable for enrollment into the study.
- Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Local Institution - 0001
Salt Lake City, Utah, 84124
ICON San Antonio
San Antonio, Texas, 78209
About this study
Official title: A Phase 1, Two-Part, Double-blind, Placebo-controlled, Randomized Study of the Safety, Tolerability, and Pharmacokinetics of BMS-986278 (Part A) and a Randomized, Double-blind, Positive-controlled, Placebo-controlled, 4-Period Crossover, Thorough QT/QTc Study to Evaluate the Effect of Multiple Doses of BMS-986278 on Cardiac Repolarization (Part B) in Healthy Participants
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics (PK) of high dose of BMS-986278 in healthy participants and to assess the effect of BMS-986278 on the ECG intervals in healthy participants.
- Conditions
- Healthy Volunteers
- Being tested
- BMS-986278, Placebo, Moxifloxacin
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
PlaceboDrug
Specified dose on specified days
MoxifloxacinDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Not described Receives: Drug: BMS-986278; Drug: Placebo |
| Part B1/B2 Treatment A | Experimental | Not described Receives: Drug: BMS-986278 |
| Part B1/B2 Treatment B | Experimental | Not described Receives: Drug: BMS-986278; Drug: Placebo |
| Part B1/B2 Treatment C | Experimental | Not described Receives: Drug: Placebo |
| Part B1/B2 Treatment D | Experimental | Not described Receives: Drug: Placebo; Drug: Moxifloxacin |
| Part B3 Treatment A | Experimental | Not described Receives: Drug: BMS-986278 |
| Part B3 Treatment B | Experimental | Not described Receives: Drug: BMS-986278; Drug: Placebo |
| Part B3 Treatment C | Experimental | Not described Receives: Drug: Placebo |
| Part B3 Treatment D | Experimental | Not described Receives: Drug: Placebo; Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with non-serious Adverse Events (AEs)
Part A
Measured: Until 28 days post last treatment dose
Number of participants with Serious AEs (SAEs)
Part A
Measured: Until 28 days post last treatment dose
Number of participants with AEs leading to study intervention discontinuation
Part A
Measured: Until 28 days post last treatment dose
Number of participants with vital sign abnormalities
Part A
Measured: Up to Day 18
Number of participants with clinical laboratory assessment abnormalities
Part A
Measured: Up to Day 18
Number of participants with 12-lead electrocardiogram (ECG) abnormalities
Part A
Measured: Up to Day 18
Number of participants with physical examination abnormalities
Part A
Measured: Up to Day 18
Change from baseline Fridericia's corrected QT interval (QTcF) (ΔQTcF)
Part B
Measured: Up to Day 13 of Period 4 (Each period is 17 days)
Placebo-corrected change from baseline QTcF (ΔΔQTcF)
Part B
Measured: Up to Day 13 of Period 4 (Each period is 17 days)
Secondary outcomes (25)
Maximum observed plasma concentration (Cmax)
Part A and Part B
Measured: Up to Day 13 of Period 4 (Each period is 17 days)
Time of maximum observed plasma concentration (Tmax)
Part A and Part B
Measured: Up to Day 13 of Period 4 (Each period is 17 days)
Area under the plasma concentration-time curve from time zero to the end of dosing interval AUC(TAU)
Part A and Part B
Measured: Up to Day 13 of Period 4 (Each period is 17 days)
Terminal half-life (T-HALF)
Part A
Measured: Up to Day 18
Apparent total body clearance (CLT/F)
Part A
Measured: Up to Day 18
Change from baseline heart rate (HR) (∆HR)
Part B
Measured: Up to Day 13 of Period 4 (Each period is 17 days)
Change from baseline PR interval (∆PR)
Part B
Measured: Up to Day 13 of Period 4 (Each period is 17 days)
Change from baseline QRS interval (∆QRS)
Part B
Measured: Up to Day 13 of Period 4 (Each period is 17 days)
Placebo-corrected change from baseline HR (ΔΔHR)
Part B
Measured: Up to Day 13 of Period 4 (Each period is 17 days)
Placebo-corrected Change from baseline PR interval (ΔΔPR)
Part B
Measured: Up to Day 13 of Period 4 (Each period is 17 days)
Placebo-corrected change from baseline QRS interval (ΔΔQRS)
Part B
Measured: Up to Day 13 of Period 4 (Each period is 17 days)
Number of participants with categorical outliers for QTcF
Part B
Measured: Up to Day 13 of Period 4 (Each period is 17 days)
Number of participants with categorical outliers for HR
Part B
Measured: Up to Day 13 of Period 4 (Each period is 17 days)
Number of participants with categorical outliers for PR interval
Part B
Measured: Up to Day 13 of Period 4 (Each period is 17 days)
Number of participants with categorical outliers for QRS interval
Part B
Measured: Up to Day 13 of Period 4 (Each period is 17 days)
Number of participants with treatment-emergent changes of ECG morphology
Part B
Measured: Up to Day 13 of Period 4 (Each period is 17 days)
ΔQTcF for moxifloxacin
Part B
Measured: Up to Day 13 of Period 4 (Each period is 17 days)
ΔΔQTcF for moxifloxacin
Part B
Measured: Up to Day 13 of Period 4 (Each period is 17 days)
Number of participants with non-serious AEs
Part B
Measured: Until 28 days post last treatment dose
Number of participants with SAEs
Part B
Measured: Until 28 days post last treatment dose
Number of participants with AEs leading to study intervention discontinuation
Part B
Measured: Until 28 days post last treatment dose
Number of participants with vital sign abnormalities
Part B
Measured: Up to Day 18 of Period 4 (Each period is 17 days)
Number of participants with clinical laboratory assessment abnormalities
Part B
Measured: Up to Day 17 of Period 4 (Each period is 17 days)
Number of participants with 12-lead ECG abnormalitie
Part B
Measured: Up to Day 17 of Period 4 (Each period is 17 days)
Number of participants with physical examination abnormalities
Part B
Measured: Up to Day 18 of Period 4 (Each period is 17 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start10 Feb 2025
- Primary completion11 Sep 2025
- Study completion11 Sep 2025
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
- Randomised
- Intervention model
- Crossover
- Model description
- Part A, a parallel model, will be followed by Part B, a 4-way crossover model.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 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
- NCT06746402
- Sponsor's protocol ID
- IM027-1012
- Status last verified
- Sep 2025
- First submitted
- 18 Dec 2024
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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/disclosurecommitment.html
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, Two-Part, Double-blind, Placebo-controlled, Randomized Study of the Safety, Tolerability, and Pharmacokinetics of BMS-986278 (Part A) and a Randomized, Double-blind, Positive-controlled, Placebo-controlled, 4-Period Crossover, Thorough QT/QTc Study to Evaluate the Effect of Multiple Doses of BMS-986278 on Cardiac Repolarization (Part B) in Healthy Participants
- ClinicalTrials.gov ID
- NCT06746402
- Acronym / sponsor ID
- IM027-1012
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 11 Sep 2025 (actual)
- Study completion
- 11 Sep 2025 (actual)
- First posted
- 24 Dec 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 determine the safety, tolerability, and pharmacokinetics (PK) of high dose of BMS-986278 in healthy participants and to assess the effect of BMS-986278 on the ECG intervals in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
- Model description
- Part A, a parallel model, will be followed by Part B, a 4-way crossover model.
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: BMS-986278, Drug: Placebo |
| Part B1/B2 Treatment A | Experimental | Drug: BMS-986278 |
| Part B1/B2 Treatment B | Experimental | Drug: BMS-986278, Drug: Placebo |
| Part B1/B2 Treatment C | Experimental | Drug: Placebo |
| Part B1/B2 Treatment D | Experimental | Drug: Placebo, Drug: Moxifloxacin |
| Part B3 Treatment A | Experimental | Drug: BMS-986278 |
| Part B3 Treatment B | Experimental | Drug: BMS-986278, Drug: Placebo |
| Part B3 Treatment C | Experimental | Drug: Placebo |
| Part B3 Treatment D | Experimental | Drug: Placebo, Drug: Moxifloxacin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female individuals not of childbearing potential (INOCBP) and males.
- Healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments.
- Body mass index (BMI) 18.0 to 32.0 kg/m2 , inclusive, for Parts A and B.
Key exclusion criteria (4 listed)
- Any significant acute or chronic medical illness as determined by the investigator.
- History of clinically relevant cardiac disease as determined by the investigator, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for ventricular arrhythmias.
- Any significant history of disease of the cardiovascular system that in the opinion of the Investigator makes the participant unsuitable for enrollment into the study.
- 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 |
|---|---|---|
| BMS-986278Specified dose on specified days | Drug | Part A, Part B1/B2 Treatment A, Part B1/B2 Treatment B, Part B3 Treatment A, Part B3 Treatment B |
| PlaceboSpecified dose on specified days | Drug | Part A, Part B1/B2 Treatment B, Part B1/B2 Treatment C, Part B1/B2 Treatment D, Part B3 Treatment B, Part B3 Treatment C, Part B3 Treatment D |
| MoxifloxacinSpecified dose on specified days | Drug | Part B1/B2 Treatment D, Part B3 Treatment D |
Primary outcome
Number of participants with non-serious Adverse Events (AEs)
Time frame: Until 28 days post last treatment dose
Part A
Number of participants with Serious AEs (SAEs)
Time frame: Until 28 days post last treatment dose
Part A
Number of participants with AEs leading to study intervention discontinuation
Time frame: Until 28 days post last treatment dose
Part A
Number of participants with vital sign abnormalities
Time frame: Up to Day 18
Part A
Number of participants with clinical laboratory assessment abnormalities
Time frame: Up to Day 18
Part A
Number of participants with 12-lead electrocardiogram (ECG) abnormalities
Time frame: Up to Day 18
Part A
Number of participants with physical examination abnormalities
Time frame: Up to Day 18
Part A
Change from baseline Fridericia's corrected QT interval (QTcF) (ΔQTcF)
Time frame: Up to Day 13 of Period 4 (Each period is 17 days)
Part B
Placebo-corrected change from baseline QTcF (ΔΔQTcF)
Time frame: Up to Day 13 of Period 4 (Each period is 17 days)
Part B
25 secondary outcomes
Maximum observed plasma concentration (Cmax)
Time frame: Up to Day 13 of Period 4 (Each period is 17 days)
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to Day 13 of Period 4 (Each period is 17 days)
Area under the plasma concentration-time curve from time zero to the end of dosing interval AUC(TAU)
Time frame: Up to Day 13 of Period 4 (Each period is 17 days)
Terminal half-life (T-HALF)
Time frame: Up to Day 18
Apparent total body clearance (CLT/F)
Time frame: Up to Day 18
Change from baseline heart rate (HR) (∆HR)
Time frame: Up to Day 13 of Period 4 (Each period is 17 days)
Change from baseline PR interval (∆PR)
Time frame: Up to Day 13 of Period 4 (Each period is 17 days)
Change from baseline QRS interval (∆QRS)
Time frame: Up to Day 13 of Period 4 (Each period is 17 days)
Placebo-corrected change from baseline HR (ΔΔHR)
Time frame: Up to Day 13 of Period 4 (Each period is 17 days)
Placebo-corrected Change from baseline PR interval (ΔΔPR)
Time frame: Up to Day 13 of Period 4 (Each period is 17 days)
Placebo-corrected change from baseline QRS interval (ΔΔQRS)
Time frame: Up to Day 13 of Period 4 (Each period is 17 days)
Number of participants with categorical outliers for QTcF
Time frame: Up to Day 13 of Period 4 (Each period is 17 days)
Number of participants with categorical outliers for HR
Time frame: Up to Day 13 of Period 4 (Each period is 17 days)
Number of participants with categorical outliers for PR interval
Time frame: Up to Day 13 of Period 4 (Each period is 17 days)
Number of participants with categorical outliers for QRS interval
Time frame: Up to Day 13 of Period 4 (Each period is 17 days)
Number of participants with treatment-emergent changes of ECG morphology
Time frame: Up to Day 13 of Period 4 (Each period is 17 days)
ΔQTcF for moxifloxacin
Time frame: Up to Day 13 of Period 4 (Each period is 17 days)
ΔΔQTcF for moxifloxacin
Time frame: Up to Day 13 of Period 4 (Each period is 17 days)
Number of participants with non-serious AEs
Time frame: Until 28 days post last treatment dose
Number of participants with SAEs
Time frame: Until 28 days post last treatment dose
Number of participants with AEs leading to study intervention discontinuation
Time frame: Until 28 days post last treatment dose
Number of participants with vital sign abnormalities
Time frame: Up to Day 18 of Period 4 (Each period is 17 days)
Number of participants with clinical laboratory assessment abnormalities
Time frame: Up to Day 17 of Period 4 (Each period is 17 days)
Number of participants with 12-lead ECG abnormalitie
Time frame: Up to Day 17 of Period 4 (Each period is 17 days)
Number of participants with physical examination abnormalities
Time frame: Up to Day 18 of Period 4 (Each period is 17 days)
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/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
2 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 and Moxifloxacin in people with Healthy Volunteers, run by Bristol-Myers Squibb at 2 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 3 inclusion and 4 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 2 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?
Number of participants with non-serious Adverse Events (AEs) (time frame: Until 28 days post last treatment dose). The study lists 9 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.