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 Squibb74 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Healthy Volunteers

Interventions

BMS-986419DRUG

Specified dose on specified days

BMS-986419 Matching PlaceboDRUG

Specified dose on specified days

MoxifloxacinDRUG

Specified dose on specified days

Moxifloxacin Matching Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Celerion

Tempe, Arizona, United States

Outcomes

Primary Outcomes

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

Vital sign parameters include temperature, systolic blood pressure (BP), diastolic BP, respiratory rate, and heart rate (HR) assessment.

Time frame: Up to approximately Day 21

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

Data from ClinicalTrials.gov

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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

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.

Time frame: 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.

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

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

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)

ΔQTc is performed by primary correction.

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

Vital sign parameters include temperature, systolic BP, diastolic BP, respiratory rate, and HR assessment.

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

Part 2: T-Half of BMS-986419

Time frame: Up to approximately Day 15

Part 2: AI_Cmax of BMS-986419

Time frame: Up to approximately Day 15

Part 2: AI_AUC(TAU) of BMS-986419

Time frame: Up to approximately Day 15

Part 2: Trough Concentration of BMS-986419

Time frame: Up to approximately Day 15