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

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Moxifloxacin Matching Placebo; Drug: Moxifloxacin; Drug: BMS-986419; Drug: BMS-986419 Matching Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06846866

CN007-1005

Details and patient eligibility

About

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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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74 participants in 5 patient groups, including a placebo group

Part 1: Administration of BMS-986419

Experimental group

Treatment:

Drug: BMS-986419

Part 1: Administration of Placebo

Placebo Comparator group

Treatment:

Drug: BMS-986419 Matching Placebo

Part 2: Group 1

Experimental group

Treatment:

Drug: BMS-986419 Matching Placebo

Drug: BMS-986419

Drug: Moxifloxacin Matching Placebo

Part 2: Group 2a

Experimental group

Treatment:

Drug: BMS-986419 Matching Placebo

Drug: Moxifloxacin

Drug: Moxifloxacin Matching Placebo

Part 2: Group 2b

Experimental group

Treatment:

Drug: BMS-986419 Matching Placebo

Drug: Moxifloxacin

Drug: Moxifloxacin Matching Placebo