临床试验/NCT02341638

NCT02341638已完成1 期

Randomized, Double-Blinded, Placebo-Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986141 in Healthy Subjects

Bristol-Myers Squibb2 个研究点分布在 1 个国家目标入组 148 人开始时间: 2014年9月最近更新: 2017年3月31日

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: 148
试验地点: 2
主要终点: Safety measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations

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, pharmacokinetics (PK) and pharmacodynamics (PD) of a single and multiple oral doses of BMS-986141 in healthy subjects.

详细描述

Maximum Age:

Part A SAD 65 years

Part B MAD 75 years

Part C MAD Japanese 75 years

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Basic Science
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
•Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI=Weight (kg)/[height(m)]2
•Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and men, ages 18 to 75, inclusive

排除标准

•Concurrent or use within 2 weeks of study drug administration, of marketed or investigational, drugs as specified in protocol
•Other protocol-defined exclusion criteria could apply

研究组 & 干预措施

Part C Panel 2: BMS-986141 or Placebo

Experimental

BMS-986141 or Placebo by mouth as specified

干预措施: Placebo (Drug)

Part A Panel 4: BMS-986141 or Placebo

Experimental

BMS-986141 or Placebo single dose by mouth as specified

干预措施: BMS-986141 (Drug)

Part A Panel 4: BMS-986141 or Placebo

Experimental

BMS-986141 or Placebo single dose by mouth as specified

干预措施: Placebo (Drug)

Part A Panel 3: BMS-986141 or Placebo

Experimental

BMS-986141 or Placebo single dose by mouth as specified

干预措施: BMS-986141 (Drug)

Part A Panel 5: BMS-986141 or Placebo

Experimental

BMS-986141 or Placebo single dose by mouth as specified

干预措施: BMS-986141 (Drug)

Part A Panel 1: BMS-986141 or Placebo

Experimental

BMS-986141 or Placebo single dose by mouth as specified

干预措施: BMS-986141 (Drug)

Part A Panel 1: BMS-986141 or Placebo

Experimental

BMS-986141 or Placebo single dose by mouth as specified

干预措施: Placebo (Drug)

Part A Panel 2: BMS-986141 or Placebo

Experimental

BMS-986141 or Placebo single dose by mouth as specified

干预措施: BMS-986141 (Drug)

Part A Panel 2: BMS-986141 or Placebo

Experimental

BMS-986141 or Placebo single dose by mouth as specified

干预措施: Placebo (Drug)

Part A Panel 3: BMS-986141 or Placebo

Experimental

BMS-986141 or Placebo single dose by mouth as specified

干预措施: Placebo (Drug)

Part A Panel 5: BMS-986141 or Placebo

Experimental

BMS-986141 or Placebo single dose by mouth as specified

干预措施: Placebo (Drug)

Part A Panel 6: BMS-986141 or Placebo

Experimental

BMS-986141 or Placebo single dose by mouth as specified

干预措施: BMS-986141 (Drug)

Part A Panel 6: BMS-986141 or Placebo

Experimental

BMS-986141 or Placebo single dose by mouth as specified

干预措施: Placebo (Drug)

Part A Panel 7: BMS-986141

Experimental

Single dose by mouth as specified

干预措施: BMS-986141 (Drug)

Part A Panel 8: BMS-986141

Experimental

Single dose by mouth as specified

干预措施: BMS-986141 (Drug)

Part B Panel 1: BMS-986141 or Placebo

Experimental

BMS-986141 or Placebo by mouth as specified

干预措施: BMS-986141 (Drug)

Part B Panel 1: BMS-986141 or Placebo

Experimental

BMS-986141 or Placebo by mouth as specified

干预措施: Placebo (Drug)

Part B Panel 2: BMS-986141 or Placebo

Experimental

BMS-986141 or Placebo by mouth as specified

干预措施: BMS-986141 (Drug)

Part B Panel 2: BMS-986141 or Placebo

Experimental

BMS-986141 or Placebo by mouth as specified

干预措施: Placebo (Drug)

Part B Panel 3: BMS-986141 or Placebo

Experimental

BMS-986141 or Placebo by mouth as specified

干预措施: BMS-986141 (Drug)

Part B Panel 3: BMS-986141 or Placebo

Experimental

BMS-986141 or Placebo by mouth as specified

干预措施: Placebo (Drug)

Part C Panel 1: BMS-986141 or Placebo

Experimental

BMS-986141 or Placebo by mouth as specified

干预措施: BMS-986141 (Drug)

Part C Panel 1: BMS-986141 or Placebo

Experimental

BMS-986141 or Placebo by mouth as specified

干预措施: Placebo (Drug)

Part C Panel 2: BMS-986141 or Placebo

Experimental

BMS-986141 or Placebo by mouth as specified

干预措施: BMS-986141 (Drug)

Part C Panel 3: BMS-986141 or Placebo

Experimental

BMS-986141 or Placebo by mouth as specified

干预措施: BMS-986141 (Drug)

Part C Panel 3: BMS-986141 or Placebo

Experimental

BMS-986141 or Placebo by mouth as specified

干预措施: Placebo (Drug)

Part D Panel 1: BMS-986141 and Aspirin

Experimental

BMS-986141 and Aspirin by mouth as specified

干预措施: BMS-986141 (Drug)

Part D Panel 1: BMS-986141 and Aspirin

Experimental

BMS-986141 and Aspirin by mouth as specified

干预措施: Aspirin (Drug)

Part D Panel 1: Placebo matching BMS-986141 and Aspirin

Placebo Comparator

BMS-986141 placebo and Aspirin by mouth as specified

干预措施: Placebo (Drug)

Part D Panel 1: Placebo matching BMS-986141 and Aspirin

Placebo Comparator

BMS-986141 placebo and Aspirin by mouth as specified

干预措施: Aspirin (Drug)

Part E Panel 1: BMS-986141 and Itraconazole

Experimental

BMS-986141 and Itraconazole by mouth as specified

干预措施: BMS-986141 (Drug)

Part E Panel 1: BMS-986141 and Itraconazole

Experimental

BMS-986141 and Itraconazole by mouth as specified

干预措施: Itraconazole (Drug)

结局指标

主要结局

Safety measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations

时间窗: Up to 30 days post discontinuation of dosing or last participation in the study

Serious adverse event (SAE) Adverse event (AE) Electrocardiogram (ECG)

Tolerability measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations

时间窗: Up to 30 days post discontinuation of dosing or last participation in the study

Tolerability measured by percent of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations

时间窗: Up to 30 days post discontinuation of dosing or last participation in the study

Safety measured by percent of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations

时间窗: Up to 30 days post discontinuation of dosing or last participation in the study

次要结局

Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986141, BMT-162853, BMT-162856, and BMT-181551(Up to Day 14)
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986141, BMT-162853, BMT-162856, and BMT-181551(Up to Day 14)
Concentration at 24 hours (C24) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551(Up to Day 14)
MR_Cmax of BMT-162853, BMT-162856, and BMT-181551(Up to Day 14)
MR_AUC(INF) of BMT-162853, BMT-162856, and BMT-181551(Up to Day 14)
AUC accumulation index (AI_AUC) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551; ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose(Up to Day 14)
Safety of multiple doses of BMS-986141 and aspirin in healthy subjects(Up to 30 days post discontinuation of dosing or last participation in the study)
Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-986141, BMT-162853, BMT-162856, and BMT-181551(Up to Day 14)
MR_AUC(0-T) of BMT-162853, BMT-162856, and BMT-181551(Up to Day 14)
Half-life (T-HALF) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551(Up to Day 14)
Effective elimination half-life that explains the degree of AUC accumulation observed (T-HALFeff_AUC) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551(Up to Day 14)
MR_AUC(TAU) of BMT-162853, BMT-162856, and BMT-181551(Up to Day 14)
Tolerability of BMS-986141 and itraconazole in healthy subjects(Up to 30 days post discontinuation of dosing or last participation in the study)
Maximum observed plasma concentration (Cmax) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551(Up to Day 14)
Time of maximum observed plasma concentration (Tmax) of BMS-986141, BMT-162853, BMT-162856, and BMT-181551(Up to Day 14)
Safety of BMS-986141 and itraconazole in healthy subjects(Up to 30 days post discontinuation of dosing or last participation in the study)
Tolerability of multiple doses of BMS-986141 and aspirin in healthy subjects(Up to 30 days post discontinuation of dosing or last participation in the study)

研究者

发起方

Bristol-Myers Squibb

申办方类型

Industry

责任方

Sponsor

研究点 (2)

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