A Phase 1, Randomized, Double-blind, Placebo-controlled, First-in-human, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Prodrug BMS-986465 and Its Active Derivative, BMS-986464, in Healthy Participants Including Healthy Participants of Japanese Ethnicity and an Open-label Assessment of Food, Formulation, and pH Effects on the Relative Bioavailability of BMS-986465 and BMS-986464
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 267
- 试验地点
- 2
- 主要终点
- Number of participants with clinical laboratory abnormalities
研究概览
简要总结
The purpose of this study is to evaluate safety, tolerability, drug and food effects on relative bioavailability of BMS-986465 and its active derivative BMS-986464 in healthy participants and healthy participants of Japanese ethnicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Healthy male and female (i e, women not of childbearing potential) participants
- •Body Mass Index (BMI) of 18 to 32 kg^m2 and total body weight ≥ 50 kg
- •Parts A, B, and D: Participants without restriction on ethnicity
- •Part C: Participants of Japanese ethnicity (both biological parents are ethnically Japanese)
排除标准
- •Clinically significant medical, psychiatric and/or sound social reason, as determined by the investigator
- •Any major surgery within 3 months of study intervention administration
- •Participation in another clinical trial concurrent with this study
- •Note: Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Part A: Single Ascending Dose (SAD) [BMS-986465 or placebo]
干预措施: Placebo (Other)
Part A: Single Ascending Dose (SAD) [BMS-986465 or placebo]
干预措施: BMS-986465 (Drug)
Part B: Multiple Ascending Dose (MAD) [BMS-986465 or placebo, Pegasys]
干预措施: BMS-986465 (Drug)
Part B: Multiple Ascending Dose (MAD) [BMS-986465 or placebo, Pegasys]
干预措施: Placebo (Other)
Part B: Multiple Ascending Dose (MAD) [BMS-986465 or placebo, Pegasys]
干预措施: Pegasys (Drug)
Part C: MAD in Japanese ethnicity [BMS-986465 or placebo]
干预措施: BMS-986465 (Drug)
Part C: MAD in Japanese ethnicity [BMS-986465 or placebo]
干预措施: Placebo (Other)
Part D: Food/Formulation/pH Effects [BMS-986465, Famotidine]
干预措施: BMS-986465 (Drug)
Part D: Food/Formulation/pH Effects [BMS-986465, Famotidine]
干预措施: Famotidine (Drug)
结局指标
主要结局
Number of participants with clinical laboratory abnormalities
时间窗: Up to 28 days
Incidence of serious adverse events (SAEs)
时间窗: Up to 28 days
Number of participants with vital sign abnormalities
时间窗: Up to 28 days
Number of participants with electrocardiogram (ECG) abnormalities
时间窗: Up to 28 days
Incidence of adverse events (AEs)
时间窗: Up to 28 days
Number of participants with physical examination abnormalities
时间窗: Up to 28 days
Treatment-emergent suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
时间窗: Up to 28 days
次要结局
- Time of maximum observed plasma concentration (Tmax)(Up to Day 27)
- Ratios of CSF to plasma concentrations(Up to 9 days)
- Maximum observed plasma concentration (Cmax)(Up to Day 27)
- Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)](Up to Day 27)
- Cerebrospinal fluid (CSF) concentrations(Up to Day 27)