NCT04965402已完成1 期
A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Japanese Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2021年7月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- PK parameters of BMS-986166: Time of maximum observed blood concentration (Tmax)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, drug levels, and drug effects of BMS-986166 in healthy Japanese male and female participants of non-childbearing potential.
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
- Double (Participant, 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
- •Japanese (both biological parents are ethnically Japanese)
- •Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiograms (ECGs), and clinical laboratory evaluations
- •Body Mass Index (BMI) of 18.0 to 32.0 kg/m^2, inclusive. BMI = weight (kg)/(height [m])^2
排除标准
- •Significant acute or chronic medical illness judged to be clinically significant by the investigator and/or Sponsor's medical monitor
- •History of heart disease, retinopathy, uveitis, other clinically significant ocular disease, gastrointestinal disease, stroke or transient ischemic attacks (TIA)
- •Inability to tolerate oral medication
- •Women who are of childbearing potential, breastfeeding, or lactating
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Panel 1: Dose 1
Experimental
干预措施: BMS-986166 (Drug)
Panel 2: Dose 2
Experimental
干预措施: BMS-986166 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
PK parameters of BMS-986166: Time of maximum observed blood concentration (Tmax)
时间窗: Day 1, Day 28
Pharmacokinetic (PK) parameters of BMS-986166: Maximum observed blood concentration (Cmax)
时间窗: Day 1, Day 28
PK parameters of BMS-986166: Area under the concentration-time curve within a dosing interval (AUC(TAU))
时间窗: Day 1, Day 28
PK parameters of BMT-121795: Tmax
时间窗: Day 1, Day 28
PK parameters of BMT-121795: AUC(TAU)
时间窗: Day 1, Day 28
PK parameters of BMT-121795: Cmax
时间窗: Day 1, Day 28
次要结局
- Severity of all AEs regardless of seriousness criteria(Up to 77 days)
- Investigator causality assessment of all AEs regardless of seriousness criteria(Up to 77 days)
- Outcomes of all AEs regardless of seriousness criteria(Up to 77 days)
- Incidence of clinically significant changes in physical examination findings(Up to 77 days)
- Severity of all SAEs(Up to 77 days)
- Outcome of all SAEs(Up to 77 days)
- Incidence of clinically significant changes in vital signs: Heart rate(Up to 77 days)
- Incidence of clinically significant changes in clinical laboratory results: Hematology tests(Up to 77 days)
- Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests(Up to 77 days)
- Incidence of clinically significant changes in ECG parameters: QRS interval(Up to 77 days)
- Incidence of clinically significant changes in ECG parameters: QT interval(Up to 77 days)
- Incidence of clinically significant changes in ECG parameters: QTcF interval(Up to 77 days)
- Incidence of clinically significant changes in continuous cardiac monitoring data(Up to 77 days)
- Incidence of clinically significant changes in vital signs: Body temperature(Up to 77 days)
- Incidence of clinically significant changes in vital signs: Respiratory rate(Up to 77 days)
- Incidence of clinically significant changes in vital signs: Blood pressure(Up to 77 days)
- Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests(Up to 77 days)
- Incidence of clinically significant changes from baseline values in electrocardiogram (ECG) parameters: PR interval(Up to 77 days)
- Incidence of all adverse events (AEs)(Up to 77 days)
- Severity of all AEs(Up to 77 days)
- Outcome of all AEs(Up to 77 days)
- Incidence of all serious adverse events (SAEs)(Up to 77 days)
- Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval(Up to 77 days)
- Incidence of clinically significant changes from baseline values in ECG parameters: QRS interval(Up to 77 days)
- Incidence of clinically significant changes from baseline values in ECG parameters: QT interval(Up to 77 days)
- Incidence of clinically significant changes from baseline values in ECG parameters: QTcF interval(Up to 77 days)
- Incidence of clinically significant changes from baseline values in continuous cardiac monitoring data(Up to 77 days)
- Incidence of clinically significant changes from baseline values in vital signs: Body temperature(Up to 77 days)
- Incidence of clinically significant changes from baseline values in vital signs: Respiratory rate(Up to 77 days)
- Incidence of clinically significant changes from baseline values in vital signs: Blood pressure(Up to 77 days)
- Incidence of clinically significant changes from baseline values in vital signs: Heart rate(Up to 77 days)
- Incidence of clinically significant changes from baseline values in clinical laboratory results: Hematology tests(Up to 77 days)
- Incidence of clinically significant changes from baseline values in clinical laboratory results: Clinical Chemistry tests(Up to 77 days)
- Incidence of clinically significant changes from baseline values in clinical laboratory results: Urinalysis tests(Up to 77 days)
研究者
研究点 (1)
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