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
NCT ID: NCT06846866
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
74 participants
INTERVENTIONAL
2025-02-27
2025-10-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Part 1: Administration of BMS-986419
BMS-986419
Specified dose on specified days
Part 1: Administration of Placebo
BMS-986419 Matching Placebo
Specified dose on specified days
Part 2: Group 1
BMS-986419
Specified dose on specified days
BMS-986419 Matching Placebo
Specified dose on specified days
Moxifloxacin Matching Placebo
Specified dose on specified days
Part 2: Group 2a
BMS-986419 Matching Placebo
Specified dose on specified days
Moxifloxacin
Specified dose on specified days
Moxifloxacin Matching Placebo
Specified dose on specified days
Part 2: Group 2b
BMS-986419 Matching Placebo
Specified dose on specified days
Moxifloxacin
Specified dose on specified days
Moxifloxacin Matching Placebo
Specified dose on specified days
Interventions
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BMS-986419
Specified dose on specified days
BMS-986419 Matching Placebo
Specified dose on specified days
Moxifloxacin
Specified dose on specified days
Moxifloxacin Matching Placebo
Specified dose on specified days
Eligibility Criteria
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Inclusion Criteria
* Participants must have a Body mass index (BMI) between 18.0 and 30.0 kilograms/meter square (kg/m\^2), inclusive, at screening.
Exclusion Criteria
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Celerion
Tempe, Arizona, United States
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CN007-1005
Identifier Type: -
Identifier Source: org_study_id
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