A Phase 1, Double-blind, Placebo-controlled, Randomized Study of the Safety, Tolerability, and Pharmacokinetics of BMS-986419 (Part 1) and a Phase 1 Randomized, Double-blind, Positive-controlled, Placebo-controlled, Parallel, Nested-crossover (Moxifloxacin-placebo) Thorough QT/QTc Study to Evaluate the Effect of Multiple Doses of BMS-986419 on Cardiac Repolarization (Part 2) in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Part 1: Number of Participants with Non-serious Adverse Events (NSAEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Part 1: Administration of BMS-986419
干预措施: BMS-986419 (Drug)
Part 1: Administration of Placebo
干预措施: BMS-986419 Matching Placebo (Drug)
Part 2: Group 1
干预措施: BMS-986419 (Drug)
Part 2: Group 1
干预措施: BMS-986419 Matching Placebo (Drug)
Part 2: Group 1
干预措施: Moxifloxacin Matching Placebo (Drug)
Part 2: Group 2a
干预措施: BMS-986419 Matching Placebo (Drug)
Part 2: Group 2a
干预措施: Moxifloxacin (Drug)
Part 2: Group 2a
干预措施: Moxifloxacin Matching Placebo (Drug)
Part 2: Group 2b
干预措施: BMS-986419 Matching Placebo (Drug)
Part 2: Group 2b
干预措施: Moxifloxacin (Drug)
Part 2: Group 2b
干预措施: Moxifloxacin Matching Placebo (Drug)
结局指标
主要结局
Part 1: Number of Participants with Non-serious Adverse Events (NSAEs)
时间窗: Up to approximately Day 42
Part 1: Number of Participants with Serious Adverse Events (SAEs)
时间窗: Up to approximately Day 42
Part 1: Number of Participants with AEs Leading to Discontinuation
时间窗: Up to approximately Day 42
Part 1: Number of Participants With AEs of Special Interest (AESI)
时间窗: Up to approximately Day 42
Part 1: Number of Participants With Clinically Significant Vital Sign Abnormalities
时间窗: 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
时间窗: Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant 12-Lead Electrocardiogram (ECG) Abnormalities
时间窗: Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant Columbia-Suicide Severity Rating Scale (C-SSRS) Abnormalities
时间窗: Up to approximately Day 21
Part 1: Number of Participants With Clinically Significant Neurological Examination Abnormalities
时间窗: Up to approximately Day 21
Part 1: Number of Participants With Physical Examination Abnormalities
时间窗: 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)
时间窗: 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
时间窗: Up to approximately Day 15
次要结局
- 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)
- Part 2: Number of Timepoints With Change in Absolute Treatment-emergent QTcF Values for BMS-986419(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(Up to approximately Day 15)
- Part 2: Number of Participants With Treatment-emergent Values of HR for BMS-986419(Up to approximately Day 15)
- Part 2: Number of Timepoints With Change in Absolute Treatment-emergent HR Values for BMS-986419(Up to approximately Day 15)
- Part 2: Number of Participants With Treatment-emergent Values of PR for BMS-986419(Up to approximately Day 15)
- Part 2: Number of Timepoints With Increase in Absolute Treatment-emergent PR Values for BMS-986419(Up to approximately Day 15)
- Part 2: Number of Participants With Treatment-emergent Values of QRS for BMS-986419(Up to approximately Day 15)
- Part 2: Number of Timepoints With Increase in Absolute Treatment-emergent QRS Values for BMS-986419(Up to approximately Day 15)
- Part 2: Number of Participants With New Onset ECG Morphology Findings(Up to approximately Day 15)
- Part 2: ΔQTc: Change From Baseline in Plasma Concentration of Moxifloxacin on Cardiac Repolarization Expressed by QT interval (QTc)(Up to approximately Day 15)
- 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)
- 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)