A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered BMS-986368 in Healthy Participants, Healthy Elderly Participants, and Healthy Participants of Japanese Ethnicity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Number of participants with electrocardiogram (ECG) abnormalities
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and drug levels of orally administered BMS-986368 in healthy participants, healthy elderly 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older 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
Cohort 2D
干预措施: BMS-986368 (Drug)
Cohort 1A
干预措施: BMS-986368 (Drug)
Cohort 1B
干预措施: BMS-986368 (Drug)
Cohort 1C
干预措施: BMS-986368 (Drug)
Cohort 2A
干预措施: BMS-986368 (Drug)
Cohort 2B
干预措施: BMS-986368 (Drug)
Cohort 2C
干预措施: BMS-986368 (Drug)
Cohort 3A
干预措施: BMS-986368 (Drug)
Cohort 3B
干预措施: BMS-986368 (Drug)
结局指标
主要结局
Number of participants with electrocardiogram (ECG) abnormalities
时间窗: Up to 21 days
Number of participants with vital sign (VS) abnormalities
时间窗: Up to 21 days
Number of participants with adverse events (AEs)
时间窗: Up to 44 days
Number of participants with physical examination abnormalities
时间窗: Up to 21 days
Number of participants with clinical laboratory asssement abnormalities
时间窗: Up to 21 days
Number of participants with treatment-emergent suicidal ideation and behavior through assessment of Columbia Suicide Severity Rating Scale (C-SSRS)
时间窗: Up to 21 days
Number of participants with serious adverse events (SAEs)
时间窗: Up to 44 days
次要结局
- Maximum observed plasma concentration (Cmax)(Up to 16 days)
- Absolute levels of monoacylglycerol lipase (MGLL) enzymatic activities in peripheral blood mononuclear cells (PBMCs)(Up to 21 days)
- Whole blood concentrations of 2-arachidonoylglycerol (2-AG)(Up to 21 days)
- Area under the plasma concentration-time curve (AUC)(Up to 16 days)
- Time of maximum observed plasma concentration (Tmax)(Up to 16 days)
- Percent change from baseline for monoacylglycerol lipase (MGLL) enzymatic activities in peripheral blood mononuclear cells (PBMCs)(Up to 21 days)
- Percent change from baseline of anandamide (AEA)(Up to 21 days)
- Plasma concentrations of anandamide (AEA)(Up to 21 days)
- Percent change from baseline of 2-arachidonoylglycerol (2-AG)(Up to 21 days)