A Phase 1, 2-Part, Open-label Study to Evaluate Relative Bioavailability of Alternate Formulations of BMS-986460 in Healthy Adult Male Participants (Part 1), and a Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of BMS-986460 in Healthy Adult Male Participants (Part 2)

Bristol-Myers Squibb2 个研究点分布在 1 个国家目标入组 85 人开始时间: 2025年3月19日最近更新: 2026年1月20日

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 85
试验地点: 2
主要终点: Part 1: Number of Participants With Adverse Events (AEs)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess the safety, tolerability, drug levels, and relative bioavailability of alternate formulations of BMS-986460 in healthy adult male participants.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 60 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Participants must be healthy as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ECGs, echocardiogram or clinical laboratory assessments, as determined by the investigator.
•Participants must have a Body mass index (BMI) between 18.0 and 35.0 kilograms/meter square (kg/m2), inclusive.
•Male participants who are sexually active with individuals of childbearing potential (IOCBP) must agree to follow instructions for methods of contraception.

排除标准

•Participants with prior exposure to BMS-986460 or with a prior history of heart failure, ischemic heart diseases, clinically significant cardiac arrythmias, or long QT syndrome are excluded.
•Participants with left ventricular ejection fraction (≤ 50%) at screening are excluded.
•Participants with history of anaphylactic reactions are excluded.
•Participants with current or recent (within 3 months of intervention administration) gastrointestinal disease that, in the opinion of the investigator, could affect the absorption of study intervention are excluded.
•Participants with history of Gilbert's syndrome are excluded.
•Other protocol-defined Inclusion/Exclusion criteria apply.

研究组 & 干预措施

Part 1: Sequence 1

Experimental

干预措施: BMS-986460 (Drug)

Part 1: Sequence 2

Experimental

干预措施: BMS-986460 (Drug)

Part 1: Sequence 3

Experimental

干预措施: BMS-986460 (Drug)

Part 2: Treatment A

Experimental

干预措施: BMS-986460 (Drug)

Part 2: Treatment B

Experimental

干预措施: BMS-986460 (Drug)

Part 2: Optional Treatment C

Experimental

干预措施: BMS-986460 (Drug)

Part 2: Optional Treatment D

Experimental

干预措施: BMS-986460 (Drug)

Part 2: Optional Treatment E

Experimental

干预措施: BMS-986460 (Drug)

结局指标

主要结局

Part 1: Number of Participants With Adverse Events (AEs)

时间窗: Up to approximately Day 43

Part 1: Number of Participants With Serious AEs (SAEs)

时间窗: Up to approximately Day 43

Part 1: Number of Participants With Clinically Significant Physical Evaluation (PE) Findings