A Randomized, Double-Blind, Placebo-Controlled, Single- And Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-986165 in Healthy Chinese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Area Under The Plasma Concentration-Time Curve From Time Zero Extrapolated To Infinite Time (AUC(INF)) of BMS-986165
研究概览
简要总结
Main objective of this study is to assess BMS-986165 plasma PK following single and multiple oral doses of BMS-986165 in healthy Chinese subjects.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed Informed Consent.
- •Healthy participants, as determined by physical examination, ECGs, and clinical laboratory and procedure determinations.
- •Body mass index (BMI) of 18 to 24 kg/m2, inclusive, and total body weight >= 50 kg.
排除标准
- •History of allergy to drug class or related compounds.
- •History or evidence of active infection within 7 days of study day
- •Drug or alcohol abuse within 6 months of study treatment administration.
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Group 2: BMS-986165 Dose 2
Participants will receive Dose 2 on Day 1, and from Day 5 - 19.
干预措施: BMS-986165 (Drug)
Group 1: BMS-986165 Dose 1
Participants will receive Dose 1 on Day 1, and from Day 5 - 19.
干预措施: BMS-986165 (Drug)
Group 1: Placebo Dose 1
Participants will receive placebo matching Dose 1 on Day 1, and from Day 5 - 19.
干预措施: Placebo (Other)
Group 2: Placebo Dose 2
Participants will receive placebo matching Dose 2 on Day 1, and from Day 5 - 19.
干预措施: Placebo (Other)
结局指标
主要结局
Area Under The Plasma Concentration-Time Curve From Time Zero Extrapolated To Infinite Time (AUC(INF)) of BMS-986165
时间窗: Day 1 to Day 4
Apparent Plasma Elimination Half-Life (T-HALF) of BMS-986165
时间窗: Days 1 to 4, Day 5, and Day 19
Maximum Observed Plasma Concentration (Cmax) of BMS-986165
时间窗: Days 1 to 4, Day 5, and Day 19
Time to Maximum Observed Plasma Concentration (Tmax) of BMS-986165
时间窗: Day 5 to Day 19
Area Under The Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) of BMS-986165
时间窗: Days 1 to 4, Day 5, and Day 19
Apparent Oral Total Body Clearance (CLT/F) of BMS-986165
时间窗: Days 1 to 4, Day 5, and Day 19
Metabolic Ratio for AUC(INF) of Metabolite (BMT-153261 and BMT-158170) Over Parent (BMS-986165) - MR(AUC[INF])
时间窗: Day 1 to Day 4
Metabolic Ratio for Cmax of Metabolite (BMT-153261 and BMT-158170) Over Parent (BMS-986165) - MR(Cmax)
时间窗: Days 1 to 4, Day 5, and Day 19
Apparent Volume of Distribution (Vz/F) of BMS-986165
时间窗: Days 1 to 4, Day 5, and Day 19
Area Under the Plasma Concentration-Time Curve in a Dosing Interval (AUC(TAU)) of BMS-986165
时间窗: Day 5 and Day 19
Effective Elimination Half-Life (T-HALFeff) of BMS-986165
时间窗: Days 1 to 4, Day 5, and Day 19
Trough Observed Plasma Concentration (Ctrough) of BMS-986165
时间窗: Day 2 to 20
Average Plasma Concentration at Steady State (Css-avg) of BMS-986165
时间窗: Days 1 to 4, Day 5, and Day 19
Accumulation Index (AI) of BMS-986165
时间窗: Days 1 to 4, Day 5, and Day 19
Metabolic Ratio for AUC(TAU) of Metabolite (BMT-153261 and BMT-158170) Over Parent (BMS-986165) - MR(AUC[TAU])
时间窗: Day 5 to Day 19
Degree of Fluctuation (DF) of BMS-986165
时间窗: Days 1 to 4, Day 5, and Day 19
次要结局
- Renal Clearance (CLR) Following Single Oral Doses of BMS-986165(Day 1 to Day 5)
- Number of participants with Adverse Events (AEs)(Up to Day 31)
- Number of Participants With Clinically Significant Change in Clinical Laboratory Values(Up to Day 24)
- Number of Participants With Clinically Significant Change in Vital Signs(Up to Day 24)
- Number of Participants With Clinically Significant Change in Electrocardiogram (ECG)(Up to Day 24)
- Number of Participants With Clinically Significant Change in Physical Examination(Up to Day 24)
- Maximum Observed Plasma Concentration (Cmax) of Metabolites BMT-153261 and BMT-158170(Days 1 to 4, Day 5, and Day 19)
- Time to Maximum Observed Plasma Concentration (Tmax) of B Metabolites BMT-153261 and BMT-158170(Days 1 to 4, Day 5, and Day 19)
- Area Under The Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) of Metabolites BMT-153261 and BMT-158170(Days 1 to 4, Day 5, and Day 19)
- Area Under The Plasma Concentration-Time Curve From Time Zero Extrapolated To Infinite Time (AUC(INF)) of Metabolites BMT-153261 and BMT-158170(Days 1 to 4, Day 5, and Day 19)
- Apparent Plasma Elimination Half-Life (T-HALF) of Metabolites BMT-153261 and BMT-158170(Days 1 to 4, Day 5, and Day 19)
- Area Under the Plasma Concentration-Time Curve in a Dosing Interval (AUC(TAU)) of Metabolites BMT-153261 and BMT-158170(Days 1 to 4, Day 5, and Day 19)
- Effective Elimination Half-Life (T-HALFeff) of Metabolites BMT-153261 and BMT-158170(Days 1 to 4, Day 5, and Day 19)
- Trough Observed Plasma Concentration (Ctrough) of Metabolites BMT-153261 and BMT-158170(Days 1 to 4, Day 5, and Day 19)
- Average Plasma Concentration at Steady State (Css-avg) of Metabolites BMT-153261 and BMT-158170(Days 1 to 4, Day 5, and Day 19)
- Accumulation Index (AI) of Metabolites BMT-153261 and BMT-158170(Days 1 to 4, Day 5, and Day 19)
- Degree of Fluctuation (DF) of Metabolites BMT-153261 and BMT-158170(Days 1 to 4, Day 5, and Day 19)
- Total Amount of Drug Recovered in Urine (URt) Following Single Oral Doses of BMS-986165(Day 1 to Day 5)
- Total Percent of Administered Dose Recovered Unchanged in Urine (%URt) Following Single Oral Doses of BMS-986165(Day 1 to Day 5)