Healthy VolunteersPhase 1NCT07422298
A Study to Evaluate the Effect 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 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of BMS-986278 on the cardiac repolarization 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
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2026to 14 Jun 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female individuals not of childbearing potential and males.
- Healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments.
- 18 to 55 years of age, inclusive, at the time of signing the informed consent with a BMI 18.0 to 32.0 kg/m2, inclusive.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, 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 in Healthy Participants
The purpose of this study is to evaluate the effect of BMS-986278 on the cardiac repolarization 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 |
|---|---|---|
| Treatment A | Experimental | Not described Receives: Drug: BMS-986278 |
| Treatment B | Experimental | Not described Receives: Drug: BMS-986278; Drug: Placebo |
| Treatment C | Placebo comparator | Not described Receives: Drug: Placebo |
| 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.
Change from baseline Fridericia's corrected QT interval (QTcF) (ΔQTcF)
Measured: Up to Day 13
Placebo-corrected change from baseline QTcF (ΔΔQTcF)
Measured: Up to Day 13
Secondary outcomes (23)
Change from baseline heart rate (HR)
Measured: Up to Day 13
Placebo-corrected change from baseline HR
Measured: Up to Day 13
Change from baseline PR interval
Measured: Up to Day 13
Placebo-corrected change from baseline PR interval
Measured: Up to Day 13
Change from baseline QRS interval
Measured: Up to Day 13
Placebo-corrected change from baseline QRS interval
Measured: Up to Day 13
Number of participants with categorical outliers for QTcF
Measured: Up to Day 13
Number of participants with categorical outliers for HR
Measured: Up to Day 13
Number of participants with categorical outliers for PR interval
Measured: Up to Day 13
Number of participants with categorical outliers for QRS interval
Measured: Up to Day 13
Number of participants with treatment-emergent changes of electrocardiogram (ECG) morphology
Measured: Up to Day 13
Change from baseline QTcF (ΔQTcF)
Measured: Up to Day 13
Placebo-corrected change from baseline QTcF (ΔΔQTcF)
Measured: Up to Day 13
Number of participants with non-serious adverse events (AEs)
Measured: Up to approximately 17 weeks
Number of participants with Serious AEs (SAEs)
Measured: Up to approximately 17 weeks
Number of participants with AEs leading to study intervention discontinuation
Measured: Up to approximately 17 weeks
Number of participants with vital sign abnormalities
Measured: Up to approximately 17 weeks
Number of participants with clinical laboratory assessment abnormalities
Measured: Up to approximately 17 weeks
Number of participants with 12-lead ECG abnormalities
Measured: Up to approximately 17 weeks
Number of participants with physical examination abnormalities
Measured: Up to approximately 17 weeks
Maximum observed concentration (Cmax)
Measured: Up to Day 13
Time of maximum observed concentration (Tmax)
Measured: Up to Day 13
Area under the concentration-time curve in 1 dosing interval (AUC[TAU])
Measured: Up to Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start19 Feb 2026
- Primary completion14 Jun 2026
- Study completion14 Jun 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
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 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
- NCT07422298
- Sponsor's protocol ID
- IM027-1055
- Status last verified
- Jul 2026
- First submitted
- 12 Feb 2026
- Last updated
- 3 Aug 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 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, 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 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07422298
- Acronym / sponsor ID
- IM027-1055
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- 14 Jun 2026 (actual)
- Study completion
- 14 Jun 2026 (actual)
- First posted
- 20 Feb 2026 (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 evaluate the effect of BMS-986278 on the cardiac repolarization 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
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: BMS-986278 |
| Treatment B | Experimental | Drug: BMS-986278, Drug: Placebo |
| Treatment C | Placebo comparator | Drug: Placebo |
| 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 (4 listed)
- Female individuals not of childbearing potential and males.
- Healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments.
- 18 to 55 years of age, inclusive, at the time of signing the informed consent with a BMI 18.0 to 32.0 kg/m2, inclusive.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Key exclusion criteria (0 listed)
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 | Treatment A, Treatment B |
| PlaceboSpecified dose on specified days | Drug | Treatment B, Treatment C, Treatment D |
| MoxifloxacinSpecified dose on specified days | Drug | Treatment D |
Primary outcome
Change from baseline Fridericia's corrected QT interval (QTcF) (ΔQTcF)
Time frame: Up to Day 13
Placebo-corrected change from baseline QTcF (ΔΔQTcF)
Time frame: Up to Day 13
23 secondary outcomes
Change from baseline heart rate (HR)
Time frame: Up to Day 13
Placebo-corrected change from baseline HR
Time frame: Up to Day 13
Change from baseline PR interval
Time frame: Up to Day 13
Placebo-corrected change from baseline PR interval
Time frame: Up to Day 13
Change from baseline QRS interval
Time frame: Up to Day 13
Placebo-corrected change from baseline QRS interval
Time frame: Up to Day 13
Number of participants with categorical outliers for QTcF
Time frame: Up to Day 13
Number of participants with categorical outliers for HR
Time frame: Up to Day 13
Number of participants with categorical outliers for PR interval
Time frame: Up to Day 13
Number of participants with categorical outliers for QRS interval
Time frame: Up to Day 13
Number of participants with treatment-emergent changes of electrocardiogram (ECG) morphology
Time frame: Up to Day 13
Change from baseline QTcF (ΔQTcF)
Time frame: Up to Day 13
Placebo-corrected change from baseline QTcF (ΔΔQTcF)
Time frame: Up to Day 13
Number of participants with non-serious adverse events (AEs)
Time frame: Up to approximately 17 weeks
Number of participants with Serious AEs (SAEs)
Time frame: Up to approximately 17 weeks
Number of participants with AEs leading to study intervention discontinuation
Time frame: Up to approximately 17 weeks
Number of participants with vital sign abnormalities
Time frame: Up to approximately 17 weeks
Number of participants with clinical laboratory assessment abnormalities
Time frame: Up to approximately 17 weeks
Number of participants with 12-lead ECG abnormalities
Time frame: Up to approximately 17 weeks
Number of participants with physical examination abnormalities
Time frame: Up to approximately 17 weeks
Maximum observed concentration (Cmax)
Time frame: Up to Day 13
Time of maximum observed concentration (Tmax)
Time frame: Up to Day 13
Area under the concentration-time curve in 1 dosing interval (AUC[TAU])
Time frame: Up to Day 13
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 3 Aug 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 BMS-986278 and Moxifloxacin 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 4 inclusion and 0 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 3 Aug 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. Some participants in this study may receive a placebo. 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?
Change from baseline Fridericia's corrected QT interval (QTcF) (ΔQTcF) (time frame: Up to Day 13). The study lists 2 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 3 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.