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

NCT06846866 | Completed Phase 1 FDA Drug

• 1 other identifier: CN007-1005
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

BMS-986419, healthy, QTC, pharmacokinetics, moxifloxacin

Outcome Measures

Primary Outcomes (12)

• Part 1: Number of Participants with Non-serious Adverse Events (NSAEs)

  Up to approximately Day 42

• Part 1: Number of Participants with Serious Adverse Events (SAEs)

  Up to approximately Day 42

• Part 1: Number of Participants with AEs Leading to Discontinuation

  Up to approximately Day 42

• Part 1: Number of Participants With AEs of Special Interest (AESI)

  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.

  Up to approximately Day 21

• Part 1: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities

  Up to approximately Day 21

• Part 1: Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities

  Up to approximately Day 21

• Part 1: Number of Participants With Clinically Significant Columbia-Suicide Severity Rating Scale (C-SSRS) Abnormalities

  Up to approximately Day 21

• Part 1: Number of Participants With Clinically Significant Neurological Examination Abnormalities

  Up to approximately Day 21

• Part 1: Number of Participants With Physical Examination Abnormalities

  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.

  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

  Up to approximately Day 15

Secondary Outcomes (44)

• Part 1: Maximum Observed Plasma Concentration (Cmax) of BMS-986419

  Up to approximately Day 21

• Part 1: Time of Maximum Plasma Observed Concentration (Tmax) of BMS-986419

  Up to approximately Day 21

• Part 1: Area Under the Concentration-time Curve in One Dosing Interval (AUC(TAU)) of BMS-986419

  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

  Up to approximately Day 21

• Part 1: Terminal Phase Elimination Half-life (T-Half) of BMS-986419

  Up to approximately Day 21

Study Arms (5)

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

Interventions

BMS-986419 DRUG

Specified dose on specified days

Part 1: Administration of BMS-986419; Part 2: Group 1

BMS-986419 Matching Placebo DRUG

Specified dose on specified days

Part 1: Administration of Placebo; Part 2: Group 1; Part 2: Group 2a; Part 2: Group 2b

Moxifloxacin DRUG

Specified dose on specified days

Part 2: Group 2a; Part 2: Group 2b

Moxifloxacin Matching Placebo DRUG

Specified dose on specified days

Part 2: Group 1; Part 2: Group 2a; Part 2: Group 2b

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 26, 2025
• Study Start: February 27, 2025
• Primary Completion: October 21, 2025
• Study Completion: October 21, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

US (1)