A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986166 in Healthy Japanese Participants
2022年2月24日 更新者：Bristol-Myers Squibb
A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Japanese Participants
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.
研究概览
研究类型
介入性
注册 (实际的)
23
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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California
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Cypress、California、美国、90630
- West Coast Clinical Trials Global
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 55年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：安慰剂
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特定日期的特定剂量
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实验性的：Panel 1: Dose 1
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特定日期的特定剂量
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实验性的：Panel 2: Dose 2
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特定日期的特定剂量
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Pharmacokinetic (PK) parameters of BMS-986166: Maximum observed blood concentration (Cmax)
大体时间：Day 1, Day 28
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Day 1, Day 28
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PK parameters of BMS-986166: Time of maximum observed blood concentration (Tmax)
大体时间：Day 1, Day 28
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Day 1, Day 28
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PK parameters of BMS-986166: Area under the concentration-time curve within a dosing interval (AUC(TAU))
大体时间：Day 1, Day 28
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Day 1, Day 28
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PK parameters of BMT-121795: Cmax
大体时间：Day 1, Day 28
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Day 1, Day 28
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PK parameters of BMT-121795: Tmax
大体时间：Day 1, Day 28
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Day 1, Day 28
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PK parameters of BMT-121795: AUC(TAU)
大体时间：Day 1, Day 28
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Day 1, Day 28
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of all adverse events (AEs)
大体时间：Up to 77 days
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Up to 77 days
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Severity of all AEs
大体时间：Up to 77 days
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Up to 77 days
|
|
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Outcome of all AEs
大体时间：Up to 77 days
|
Up to 77 days
|
|
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Incidence of all serious adverse events (SAEs)
大体时间：Up to 77 days
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Up to 77 days
|
|
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Severity of all SAEs
大体时间：Up to 77 days
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Up to 77 days
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Outcome of all SAEs
大体时间：Up to 77 days
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Up to 77 days
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Severity of all AEs regardless of seriousness criteria
大体时间：Up to 77 days
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Up to 77 days
|
|
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Investigator causality assessment of all AEs regardless of seriousness criteria
大体时间：Up to 77 days
|
Up to 77 days
|
|
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Outcomes of all AEs regardless of seriousness criteria
大体时间：Up to 77 days
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Up to 77 days
|
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Incidence of clinically significant changes in physical examination findings
大体时间：Up to 77 days
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Up to 77 days
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Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
大体时间：Up to 77 days
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PR interval: The time from the onset of the P wave to the start of the QRS complex
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Up to 77 days
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Incidence of clinically significant changes in ECG parameters: QRS interval
大体时间：Up to 77 days
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QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
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Up to 77 days
|
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Incidence of clinically significant changes in ECG parameters: QT interval
大体时间：Up to 77 days
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QT interval: Measured from the beginning of the QRS complex to the end of the T wave
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Up to 77 days
|
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Incidence of clinically significant changes in ECG parameters: QTcF interval
大体时间：Up to 77 days
|
QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
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Up to 77 days
|
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Incidence of clinically significant changes in continuous cardiac monitoring data
大体时间：Up to 77 days
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Up to 77 days
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Incidence of clinically significant changes in vital signs: Body temperature
大体时间：Up to 77 days
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Up to 77 days
|
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Incidence of clinically significant changes in vital signs: Respiratory rate
大体时间：Up to 77 days
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Up to 77 days
|
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Incidence of clinically significant changes in vital signs: Blood pressure
大体时间：Up to 77 days
|
Up to 77 days
|
|
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Incidence of clinically significant changes in vital signs: Heart rate
大体时间：Up to 77 days
|
Up to 77 days
|
|
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Incidence of clinically significant changes in clinical laboratory results: Hematology tests
大体时间：Up to 77 days
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Up to 77 days
|
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Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
大体时间：Up to 77 days
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Up to 77 days
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Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
大体时间：Up to 77 days
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Up to 77 days
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Incidence of clinically significant changes from baseline values in electrocardiogram (ECG) parameters: PR interval
大体时间：Up to 77 days
|
Up to 77 days
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Incidence of clinically significant changes from baseline values in ECG parameters: QRS interval
大体时间：Up to 77 days
|
Up to 77 days
|
|
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Incidence of clinically significant changes from baseline values in ECG parameters: QT interval
大体时间：Up to 77 days
|
Up to 77 days
|
|
|
Incidence of clinically significant changes from baseline values in ECG parameters: QTcF interval
大体时间：Up to 77 days
|
Up to 77 days
|
|
|
Incidence of clinically significant changes from baseline values in continuous cardiac monitoring data
大体时间：Up to 77 days
|
Up to 77 days
|
|
|
Incidence of clinically significant changes from baseline values in vital signs: Body temperature
大体时间：Up to 77 days
|
Up to 77 days
|
|
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Incidence of clinically significant changes from baseline values in vital signs: Respiratory rate
大体时间：Up to 77 days
|
Up to 77 days
|
|
|
Incidence of clinically significant changes from baseline values in vital signs: Blood pressure
大体时间：Up to 77 days
|
Up to 77 days
|
|
|
Incidence of clinically significant changes from baseline values in vital signs: Heart rate
大体时间：Up to 77 days
|
Up to 77 days
|
|
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Incidence of clinically significant changes from baseline values in clinical laboratory results: Hematology tests
大体时间：Up to 77 days
|
Up to 77 days
|
|
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Incidence of clinically significant changes from baseline values in clinical laboratory results: Clinical Chemistry tests
大体时间：Up to 77 days
|
Up to 77 days
|
|
|
Incidence of clinically significant changes from baseline values in clinical laboratory results: Urinalysis tests
大体时间：Up to 77 days
|
Up to 77 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年7月15日
初级完成 (实际的)
2022年2月7日
研究完成 (实际的)
2022年2月7日
研究注册日期
首次提交
2021年7月7日
首先提交符合 QC 标准的
2021年7月7日
首次发布 (实际的)
2021年7月16日
研究记录更新
最后更新发布 (实际的)
2022年3月9日
上次提交的符合 QC 标准的更新
2022年2月24日
最后验证
2022年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.