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
- Conditions
- Healthy Volunteers
- Interventions
- Drug: BMS-986419 Matching PlaceboDrug: Moxifloxacin Matching Placebo
- Registration Number
- NCT06846866
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 74
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: Administration of Placebo BMS-986419 Matching Placebo - Part 2: Group 1 BMS-986419 Matching Placebo - Part 2: Group 1 Moxifloxacin Matching Placebo - Part 2: Group 2a BMS-986419 Matching Placebo - Part 2: Group 2a Moxifloxacin - Part 2: Group 2a Moxifloxacin Matching Placebo - Part 2: Group 2b BMS-986419 Matching Placebo - Part 2: Group 2b Moxifloxacin - Part 2: Group 2b Moxifloxacin Matching Placebo - Part 1: Administration of BMS-986419 BMS-986419 - Part 2: Group 1 BMS-986419 -
- Primary Outcome Measures
Name Time Method 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 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 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) 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 Up to approximately Day 15
- Secondary Outcome Measures
Name Time Method 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 Part 1: Accumulation Index; Ratio of Cmax at Steady-state to Cmax After the First Dose (AI_Cmax) of BMS-986419 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 Up to approximately Day 21 Part 1: Apparent Total Body Clearance (CLT/F) of BMS-986419 Up to approximately Day 21 Part 1: Apparent Volume of Distribution of Terminal Phase (Vz/F) of BMS-986419 Up to approximately Day 21 Part 1: Trough Concentration of BMS-986419 Up to approximately Day 21 Part 2: ΔQTc of BMS-986419 Using Change From Baseline of Heart Rate (HR)(ΔHR) Correction Up to approximately Day 15 Part 2: ΔQTc of BMS-986419 Using Change From Baseline of Pulse Rate (PR)(ΔPR) Correction Up to approximately Day 15 Part 2: ΔQTc of BMS-986419 Using Change From Baseline of Respiratory Rate (RR) Interval Correction Up to approximately Day 15 Part 2: Change From Baseline of BMS-986419 in Quality Rating System (QRS) Interval (ΔQRS) Up to approximately Day 15 Part 2: Number of Participants With Treatment-emergent Values of Fridericia's Corrected QT interval (QTcF) for BMS-986419 Up to approximately Day 15 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.
Part 2: Number of Timepoints With Change in Absolute Treatment-emergent QTcF Values for BMS-986419 Up to approximately Day 15 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.
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 Up to approximately Day 15 Part 2: Number of Participants With Treatment-emergent Values of HR for BMS-986419 Up to approximately Day 15 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.
Part 2: Number of Timepoints With Change in Absolute Treatment-emergent HR Values for BMS-986419 Up to approximately Day 15 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.
Part 2: Number of Participants With Treatment-emergent Values of PR for BMS-986419 Up to approximately Day 15 Participants with increase in PR from pre-dose baseline \>25% to a PR\>200 msec will be determined.
Part 2: Number of Timepoints With Increase in Absolute Treatment-emergent PR Values for BMS-986419 Up to approximately Day 15 Number of timepoints with increase in PR from pre-dose baseline \>25% to a PR\>200 msec will be determined.
Part 2: Number of Participants With Treatment-emergent Values of QRS for BMS-986419 Up to approximately Day 15 Participants with increase in QRS from pre-dose baseline \>25% to a QRS \>120 msec will be determined.
Part 2: Number of Timepoints With Increase in Absolute Treatment-emergent QRS Values for BMS-986419 Up to approximately Day 15 Number of timepoints with increase in QRS from pre-dose baseline \>25% to a QRS \>120 msec will be determined.
Part 2: Number of Participants With New Onset ECG Morphology Findings Up to approximately Day 15 "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).
Part 2: ΔQTc: Change From Baseline in Plasma Concentration of Moxifloxacin on Cardiac Repolarization Expressed by QT interval (QTc) Up to approximately Day 15 ΔQTc is performed by primary correction.
Part 2: ΔΔQTc: Placebo-corrected Change From Baseline QTc Plasma Concentration of Moxifloxacin on Cardiac Repolarization Expressed by QTc Up to approximately Day 15 Part 2: Number of Participants with NSAEs Up to approximately Day 36 Part 2: Number of Participants with SAEs Up to approximately Day 36 Part 2: Number of Participants with AEs Leading to Discontinuation Up to approximately Day 36 Part 2: Number of Participants With AESI Up to approximately Day 36 Part 2: Number of Participants With Clinically Significant Vital Sign Abnormalities Up to approximately Day 15 Vital sign parameters include temperature, systolic BP, diastolic BP, respiratory rate, and HR assessment.
Part 2: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities Up to approximately Day 14 Part 2: Number of Participants With Clinically Significant 12-Lead ECG Abnormalities Up to approximately Day 15 Part 2: Number of Participants With Clinically Significant C-SSRS Abnormalities Up to approximately Day 15 Part 2: Number of Participants With Clinically Significant Neurological Examination Abnormalities Up to approximately Day 15 Part 2: Number of Participants With Physical Examination Abnormalities Up to approximately Day 15 Part 2: Cmax of BMS-986419 Up to approximately Day 15 Part 2: Tmax of BMS-986419 Up to approximately Day 15 Part 2: AUC(0-T) of BMS-986419 Up to approximately Day 15 Part 2: AUC(TAU) of BMS-986419 Up to approximately Day 15 Part 2: T-Half of BMS-986419 Up to approximately Day 15 Part 2: AI_Cmax of BMS-986419 Up to approximately Day 15 Part 2: AI_AUC(TAU) of BMS-986419 Up to approximately Day 15 Part 2: Trough Concentration of BMS-986419 Up to approximately Day 15
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (1)
Celerion
🇺🇸Tempe, Arizona, United States