Healthy VolunteersPhase 1NCT06846866
A Study to Investigate the Safety, Tolerability, and Drug Levels of BMS-986419 (Part 1) and the Effects Multiple Doses of BMS-986419 on Cardiac Repolarization (Part 2) in Healthy Participants
A Phase 1 study testing BMS-986419 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 investigate the safety, tolerability, and pharmacokinetics of BMS-986419 (Part 1) and the effects of multiple doses of BMS-986419 on cardiac repolarization (Part 2) 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-986419 and Moxifloxacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2025to 21 Oct 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
- Participants must be healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments.
- Participants must have a Body mass index (BMI) between 18.0 and 30.0 kilograms/meter square (kg/m^2), inclusive, at screening.
Who cannot join
- Participants must not have any significant acute or chronic medical illness as determined by the investigator.
- Participants must not have any current or recent (within 3 months of study intervention administration) GI disease, liver and kidney that could possibly affect drug absorption, distribution, metabolism, and excretion, (e.g., bariatric procedure, Cholecystectomy, and any other GI surgery that could impact upon the absorption of study intervention).
- Participants must not have Gilbert Syndrome.
- Participants must not have a 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 (e.g., long QT syndrome, catecholamine polymorphic ventricular tachycardia).
- Participants must not have exposure to any investigational drug or placebo (other than BMS-986419 or moxifloxacin) within 4 weeks or 5 half-lives (whichever is longer) prior to Day -1 (Day -2 for Part 2) until follow-up phone call.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-blind, Placebo-controlled, Randomized Study of the Safety, Tolerability, and Pharmacokinetics of BMS-986419 (Part 1) and a Phase 1 Randomized, Double-blind, Positive-controlled, Placebo-controlled, Parallel, Nested-crossover (Moxifloxacin-placebo) Thorough QT/QTc Study to Evaluate the Effect of Multiple Doses of BMS-986419 on Cardiac Repolarization (Part 2) in Healthy Participants
The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of BMS-986419 (Part 1) and the effects of multiple doses of BMS-986419 on cardiac repolarization (Part 2) in healthy participants.
- Conditions
- Healthy Volunteers
- Being tested
- BMS-986419, BMS-986419 Matching Placebo, Moxifloxacin, Moxifloxacin Matching Placebo
- Keywords
- BMS-986419, healthy, QTC, pharmacokinetics, moxifloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986419Drug
Specified dose on specified days
BMS-986419 Matching PlaceboDrug
Specified dose on specified days
MoxifloxacinDrug
Specified dose on specified days
Moxifloxacin Matching PlaceboDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Administration of BMS-986419 | Experimental | Not described Receives: Drug: BMS-986419 |
| Part 1: Administration of Placebo | Placebo comparator | Not described Receives: Drug: BMS-986419 Matching Placebo |
| Part 2: Group 1 | Experimental | Not described Receives: Drug: BMS-986419; Drug: BMS-986419 Matching Placebo; Drug: Moxifloxacin Matching Placebo |
| Part 2: Group 2a | Experimental | Not described Receives: Drug: BMS-986419 Matching Placebo; Drug: Moxifloxacin; Drug: Moxifloxacin Matching Placebo |
| Part 2: Group 2b | Experimental | Not described Receives: Drug: BMS-986419 Matching Placebo; Drug: Moxifloxacin; Drug: Moxifloxacin Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Participants with Non-serious Adverse Events (NSAEs)
Measured: Up to approximately Day 42
Part 1: Number of Participants with Serious Adverse Events (SAEs)
Measured: Up to approximately Day 42
Part 1: Number of Participants with AEs Leading to Discontinuation
Measured: Up to approximately Day 42
Part 1: Number of Participants With AEs of Special Interest (AESI)
Measured: Up to approximately Day 42
Part 1: Number of Participants With Clinically Significant Vital Sign Abnormalities
Vital sign parameters include temperature, systolic blood pressure (BP), diastolic BP, respiratory rate, and heart rate (HR) assessment.
Measured: Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Measured: Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities
Measured: Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant Columbia-Suicide Severity Rating Scale (C-SSRS) Abnormalities
Measured: Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant Neurological Examination Abnormalities
Measured: Up to approximately Day 21
Part 1: Number of Participants With Physical Examination Abnormalities
Measured: Up to approximately Day 21
Part 2: ΔQTc: Change From Baseline in Plasma Concentration of BMS-986419 on Cardiac Repolarization Expressed by QT interval (QTc)
ΔQTc is performed by primary correction.
Measured: Up to approximately Day 15
Part 2: ΔΔQTc: Placebo-corrected Change From Baseline QTc Plasma Concentration of BMS-986419 on Cardiac Repolarization Expressed by QTc
Measured: Up to approximately Day 15
Secondary outcomes (44)
Part 1: Maximum Observed Plasma Concentration (Cmax) of BMS-986419
Measured: Up to approximately Day 21
Part 1: Time of Maximum Plasma Observed Concentration (Tmax) of BMS-986419
Measured: Up to approximately Day 21
Part 1: Area Under the Concentration-time Curve in One Dosing Interval (AUC(TAU)) of BMS-986419
Measured: Up to approximately Day 21
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC [0-T]) of BMS-986419
Measured: Up to approximately Day 21
Part 1: Terminal Phase Elimination Half-life (T-Half) of BMS-986419
Measured: Up to approximately Day 21
Part 1: Accumulation Index; Ratio of Cmax at Steady-state to Cmax After the First Dose (AI_Cmax) of BMS-986419
Measured: Up to approximately Day 21
Part 1: Accumulation Index; Ratio of AUC(TAU) at Steady-state to AUC(TAU) After the First Dose [AI_AUC(TAU)] of BMS-986419
Measured: Up to approximately Day 21
Part 1: Apparent Total Body Clearance (CLT/F) of BMS-986419
Measured: Up to approximately Day 21
Part 1: Apparent Volume of Distribution of Terminal Phase (Vz/F) of BMS-986419
Measured: Up to approximately Day 21
Part 1: Trough Concentration of BMS-986419
Measured: Up to approximately Day 21
Part 2: ΔQTc of BMS-986419 Using Change From Baseline of Heart Rate (HR)(ΔHR) Correction
Measured: Up to approximately Day 15
Part 2: ΔQTc of BMS-986419 Using Change From Baseline of Pulse Rate (PR)(ΔPR) Correction
Measured: Up to approximately Day 15
Part 2: ΔQTc of BMS-986419 Using Change From Baseline of Respiratory Rate (RR) Interval Correction
Measured: Up to approximately Day 15
Part 2: Change From Baseline of BMS-986419 in Quality Rating System (QRS) Interval (ΔQRS)
Measured: Up to approximately Day 15
Part 2: Number of Participants With Treatment-emergent Values of Fridericia's Corrected QT interval (QTcF) for BMS-986419
Participants with increase in absolute treatment-emergent QTc values >450 and ≤480 milliseconds (msec), >480 and ≤500 msec, or >500 msec, and changes from pre-dose baseline of >30 and ≤ 60 msec, or >60 msec will be measured.
Measured: Up to approximately Day 15
Part 2: Number of Timepoints With Change in Absolute Treatment-emergent QTcF Values for BMS-986419
Number of timepoints with increase in absolute treatment-emergent QTc values >450 and ≤480 milliseconds (msec), >480 and ≤500 msec, or >500 msec, and changes from pre-dose baseline of >30 and ≤ 60 msec, or >60 msec will be measured.
Measured: Up to approximately Day 15
Part 2: Number of Participants With Treatment-emergent Values of Individualized Heart Rate-corrected Interval/Optimized HR-corrected QT Interval (QTcS/QTcI) for BMS-986419
Measured: Up to approximately Day 15
Part 2: Number of Participants With Treatment-emergent Values of HR for BMS-986419
Participants with decrease in HR from pre-dose baseline >25% to a HR <50 beats per minute (bpm); and increase in HR from pre-dose baseline >25% to a HR >100 bpm will be determined.
Measured: Up to approximately Day 15
Part 2: Number of Timepoints With Change in Absolute Treatment-emergent HR Values for BMS-986419
Number of timepoints with decrease in HR from pre-dose baseline >25% to a HR <50 beats per minute (bpm); and increase in HR from pre-dose baseline >25% to a HR >100 bpm will be determined.
Measured: Up to approximately Day 15
Part 2: Number of Participants With Treatment-emergent Values of PR for BMS-986419
Participants with increase in PR from pre-dose baseline >25% to a PR>200 msec will be determined.
Measured: Up to approximately Day 15
Part 2: Number of Timepoints With Increase in Absolute Treatment-emergent PR Values for BMS-986419
Number of timepoints with increase in PR from pre-dose baseline >25% to a PR>200 msec will be determined.
Measured: Up to approximately Day 15
Part 2: Number of Participants With Treatment-emergent Values of QRS for BMS-986419
Participants with increase in QRS from pre-dose baseline >25% to a QRS >120 msec will be determined.
Measured: Up to approximately Day 15
Part 2: Number of Timepoints With Increase in Absolute Treatment-emergent QRS Values for BMS-986419
Number of timepoints with increase in QRS from pre-dose baseline >25% to a QRS >120 msec will be determined.
Measured: Up to approximately Day 15
Part 2: Number of Participants With New Onset ECG Morphology Findings
"New" means an ECG finding that is not present on any baseline ECG [that is, any ECG recorded prior to receipt of the first dose of study BMS-986419] and becomes present on at least 1 on-treatment ECG during that treatment period).
Measured: Up to approximately Day 15
Part 2: ΔQTc: Change From Baseline in Plasma Concentration of Moxifloxacin on Cardiac Repolarization Expressed by QT interval (QTc)
ΔQTc is performed by primary correction.
Measured: Up to approximately Day 15
Part 2: ΔΔQTc: Placebo-corrected Change From Baseline QTc Plasma Concentration of Moxifloxacin on Cardiac Repolarization Expressed by QTc
Measured: Up to approximately Day 15
Part 2: Number of Participants with NSAEs
Measured: Up to approximately Day 36
Part 2: Number of Participants with SAEs
Measured: Up to approximately Day 36
Part 2: Number of Participants with AEs Leading to Discontinuation
Measured: Up to approximately Day 36
Part 2: Number of Participants With AESI
Measured: Up to approximately Day 36
Part 2: Number of Participants With Clinically Significant Vital Sign Abnormalities
Vital sign parameters include temperature, systolic BP, diastolic BP, respiratory rate, and HR assessment.
Measured: Up to approximately Day 15
Part 2: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Measured: Up to approximately Day 14
Part 2: Number of Participants With Clinically Significant 12-Lead ECG Abnormalities
Measured: Up to approximately Day 15
Part 2: Number of Participants With Clinically Significant C-SSRS Abnormalities
Measured: Up to approximately Day 15
Part 2: Number of Participants With Clinically Significant Neurological Examination Abnormalities
Measured: Up to approximately Day 15
Part 2: Number of Participants With Physical Examination Abnormalities
Measured: Up to approximately Day 15
Part 2: Cmax of BMS-986419
Measured: Up to approximately Day 15
Part 2: Tmax of BMS-986419
Measured: Up to approximately Day 15
Part 2: AUC(0-T) of BMS-986419
Measured: Up to approximately Day 15
Part 2: AUC(TAU) of BMS-986419
Measured: Up to approximately Day 15
Part 2: T-Half of BMS-986419
Measured: Up to approximately Day 15
Part 2: AI_Cmax of BMS-986419
Measured: Up to approximately Day 15
Part 2: AI_AUC(TAU) of BMS-986419
Measured: Up to approximately Day 15
Part 2: Trough Concentration of BMS-986419
Measured: Up to approximately Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start27 Feb 2025
- Primary completion21 Oct 2025
- Study completion21 Oct 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 74 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
- NCT06846866
- Sponsor's protocol ID
- CN007-1005
- Status last verified
- Nov 2025
- First submitted
- 21 Feb 2025
- Last updated
- 17 Nov 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-blind, Placebo-controlled, Randomized Study of the Safety, Tolerability, and Pharmacokinetics of BMS-986419 (Part 1) and a Phase 1 Randomized, Double-blind, Positive-controlled, Placebo-controlled, Parallel, Nested-crossover (Moxifloxacin-placebo) Thorough QT/QTc Study to Evaluate the Effect of Multiple Doses of BMS-986419 on Cardiac Repolarization (Part 2) in Healthy Participants
- ClinicalTrials.gov ID
- NCT06846866
- Acronym / sponsor ID
- CN007-1005
- Conditions
- Healthy Volunteers
- Keywords
- BMS-986419, healthy, QTC, pharmacokinetics, moxifloxacin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 21 Oct 2025 (actual)
- Study completion
- 21 Oct 2025 (actual)
- First posted
- 26 Feb 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 this study is to investigate the safety, tolerability, and pharmacokinetics of BMS-986419 (Part 1) and the effects of multiple doses of BMS-986419 on cardiac repolarization (Part 2) in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1: Administration of BMS-986419 | Experimental | Drug: BMS-986419 |
| Part 1: Administration of Placebo | Placebo comparator | Drug: BMS-986419 Matching Placebo |
| Part 2: Group 1 | Experimental | Drug: BMS-986419, Drug: BMS-986419 Matching Placebo, Drug: Moxifloxacin Matching Placebo |
| Part 2: Group 2a | Experimental | Drug: BMS-986419 Matching Placebo, Drug: Moxifloxacin, Drug: Moxifloxacin Matching Placebo |
| Part 2: Group 2b | Experimental | Drug: BMS-986419 Matching Placebo, Drug: Moxifloxacin, Drug: Moxifloxacin Matching Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participants must be healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments.
- Participants must have a Body mass index (BMI) between 18.0 and 30.0 kilograms/meter square (kg/m^2), inclusive, at screening.
Key exclusion criteria (6 listed)
- Participants must not have any significant acute or chronic medical illness as determined by the investigator.
- Participants must not have any current or recent (within 3 months of study intervention administration) GI disease, liver and kidney that could possibly affect drug absorption, distribution, metabolism, and excretion, (e.g., bariatric procedure, Cholecystectomy, and any other GI surgery that could impact upon the absorption of study intervention).
- Participants must not have Gilbert Syndrome.
- Participants must not have a 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 (e.g., long QT syndrome, catecholamine polymorphic ventricular tachycardia).
- Participants must not have exposure to any investigational drug or placebo (other than BMS-986419 or moxifloxacin) within 4 weeks or 5 half-lives (whichever is longer) prior to Day -1 (Day -2 for Part 2) until follow-up phone call.
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-986419Specified dose on specified days | Drug | Part 1: Administration of BMS-986419, Part 2: Group 1 |
| BMS-986419 Matching PlaceboSpecified dose on specified days | Drug | Part 1: Administration of Placebo, Part 2: Group 1, Part 2: Group 2a, Part 2: Group 2b |
| MoxifloxacinSpecified dose on specified days | Drug | Part 2: Group 2a, Part 2: Group 2b |
| Moxifloxacin Matching PlaceboSpecified dose on specified days | Drug | Part 2: Group 1, Part 2: Group 2a, Part 2: Group 2b |
Primary outcome
Part 1: Number of Participants with Non-serious Adverse Events (NSAEs)
Time frame: Up to approximately Day 42
Part 1: Number of Participants with Serious Adverse Events (SAEs)
Time frame: Up to approximately Day 42
Part 1: Number of Participants with AEs Leading to Discontinuation
Time frame: Up to approximately Day 42
Part 1: Number of Participants With AEs of Special Interest (AESI)
Time frame: Up to approximately Day 42
Part 1: Number of Participants With Clinically Significant Vital Sign Abnormalities
Time frame: Up to approximately Day 21
Vital sign parameters include temperature, systolic blood pressure (BP), diastolic BP, respiratory rate, and heart rate (HR) assessment.
Part 1: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Time frame: Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities
Time frame: Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant Columbia-Suicide Severity Rating Scale (C-SSRS) Abnormalities
Time frame: Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant Neurological Examination Abnormalities
Time frame: Up to approximately Day 21
Part 1: Number of Participants With Physical Examination Abnormalities
Time frame: Up to approximately Day 21
Part 2: ΔQTc: Change From Baseline in Plasma Concentration of BMS-986419 on Cardiac Repolarization Expressed by QT interval (QTc)
Time frame: Up to approximately Day 15
ΔQTc is performed by primary correction.
Part 2: ΔΔQTc: Placebo-corrected Change From Baseline QTc Plasma Concentration of BMS-986419 on Cardiac Repolarization Expressed by QTc
Time frame: Up to approximately Day 15
44 secondary outcomes
Part 1: Maximum Observed Plasma Concentration (Cmax) of BMS-986419
Time frame: Up to approximately Day 21
Part 1: Time of Maximum Plasma Observed Concentration (Tmax) of BMS-986419
Time frame: Up to approximately Day 21
Part 1: Area Under the Concentration-time Curve in One Dosing Interval (AUC(TAU)) of BMS-986419
Time frame: Up to approximately Day 21
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC [0-T]) of BMS-986419
Time frame: Up to approximately Day 21
Part 1: Terminal Phase Elimination Half-life (T-Half) of BMS-986419
Time frame: Up to approximately Day 21
Part 1: Accumulation Index; Ratio of Cmax at Steady-state to Cmax After the First Dose (AI_Cmax) of BMS-986419
Time frame: Up to approximately Day 21
Part 1: Accumulation Index; Ratio of AUC(TAU) at Steady-state to AUC(TAU) After the First Dose [AI_AUC(TAU)] of BMS-986419
Time frame: Up to approximately Day 21
Part 1: Apparent Total Body Clearance (CLT/F) of BMS-986419
Time frame: Up to approximately Day 21
Part 1: Apparent Volume of Distribution of Terminal Phase (Vz/F) of BMS-986419
Time frame: Up to approximately Day 21
Part 1: Trough Concentration of BMS-986419
Time frame: Up to approximately Day 21
Part 2: ΔQTc of BMS-986419 Using Change From Baseline of Heart Rate (HR)(ΔHR) Correction
Time frame: Up to approximately Day 15
Part 2: ΔQTc of BMS-986419 Using Change From Baseline of Pulse Rate (PR)(ΔPR) Correction
Time frame: Up to approximately Day 15
Part 2: ΔQTc of BMS-986419 Using Change From Baseline of Respiratory Rate (RR) Interval Correction
Time frame: Up to approximately Day 15
Part 2: Change From Baseline of BMS-986419 in Quality Rating System (QRS) Interval (ΔQRS)
Time frame: Up to approximately Day 15
Part 2: Number of Participants With Treatment-emergent Values of Fridericia's Corrected QT interval (QTcF) for BMS-986419
Time frame: Up to approximately Day 15
Part 2: Number of Timepoints With Change in Absolute Treatment-emergent QTcF Values for BMS-986419
Time frame: Up to approximately Day 15
Part 2: Number of Participants With Treatment-emergent Values of Individualized Heart Rate-corrected Interval/Optimized HR-corrected QT Interval (QTcS/QTcI) for BMS-986419
Time frame: Up to approximately Day 15
Part 2: Number of Participants With Treatment-emergent Values of HR for BMS-986419
Time frame: Up to approximately Day 15
Part 2: Number of Timepoints With Change in Absolute Treatment-emergent HR Values for BMS-986419
Time frame: Up to approximately Day 15
Part 2: Number of Participants With Treatment-emergent Values of PR for BMS-986419
Time frame: Up to approximately Day 15
Part 2: Number of Timepoints With Increase in Absolute Treatment-emergent PR Values for BMS-986419
Time frame: Up to approximately Day 15
Part 2: Number of Participants With Treatment-emergent Values of QRS for BMS-986419
Time frame: Up to approximately Day 15
Part 2: Number of Timepoints With Increase in Absolute Treatment-emergent QRS Values for BMS-986419
Time frame: Up to approximately Day 15
Part 2: Number of Participants With New Onset ECG Morphology Findings
Time frame: Up to approximately Day 15
Part 2: ΔQTc: Change From Baseline in Plasma Concentration of Moxifloxacin on Cardiac Repolarization Expressed by QT interval (QTc)
Time frame: Up to approximately Day 15
Part 2: ΔΔQTc: Placebo-corrected Change From Baseline QTc Plasma Concentration of Moxifloxacin on Cardiac Repolarization Expressed by QTc
Time frame: Up to approximately Day 15
Part 2: Number of Participants with NSAEs
Time frame: Up to approximately Day 36
Part 2: Number of Participants with SAEs
Time frame: Up to approximately Day 36
Part 2: Number of Participants with AEs Leading to Discontinuation
Time frame: Up to approximately Day 36
Part 2: Number of Participants With AESI
Time frame: Up to approximately Day 36
Part 2: Number of Participants With Clinically Significant Vital Sign Abnormalities
Time frame: Up to approximately Day 15
Part 2: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Time frame: Up to approximately Day 14
Part 2: Number of Participants With Clinically Significant 12-Lead ECG Abnormalities
Time frame: Up to approximately Day 15
Part 2: Number of Participants With Clinically Significant C-SSRS Abnormalities
Time frame: Up to approximately Day 15
Part 2: Number of Participants With Clinically Significant Neurological Examination Abnormalities
Time frame: Up to approximately Day 15
Part 2: Number of Participants With Physical Examination Abnormalities
Time frame: Up to approximately Day 15
Part 2: Cmax of BMS-986419
Time frame: Up to approximately Day 15
Part 2: Tmax of BMS-986419
Time frame: Up to approximately Day 15
Part 2: AUC(0-T) of BMS-986419
Time frame: Up to approximately Day 15
Part 2: AUC(TAU) of BMS-986419
Time frame: Up to approximately Day 15
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 17 Nov 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
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-986419 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 2 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 17 Nov 2025. 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?
Part 1: Number of Participants with Non-serious Adverse Events (NSAEs) (time frame: Up to approximately Day 42). The study lists 12 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 17 Nov 2025.