Pharmacokinetic and Metabolism of [14^C] BMS-986177 in Healthy Male Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Assess PK Cmax of a dose of [14C]BMS-986177
研究概览
简要总结
This is an ADME study. Human radiolabeled mass balance studies are performed as part of drug development to obtain information about the absorption, distribution, metabolism, and excretion (ADME) of a study treatment. The goals of human ADME studies include the assessment of absorption, distribution, routes and rates of excretion, mass balance, and metabolite profile and identification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed ICF
- •Healthy Male
- •Body mass index of 18.0 to 32.0 kg/m2, inclusive.
- •Agreement to use approved contraception for 94 days post treatment
- •Agreement to not donate sperm for 94 days post treatment
排除标准
- •Acute or chronic illness
- •GI disease current or recent
- •History of dizziness or recurring headaches
- •Head injury within last 2 years
- •GI surgery
- •History or evidence of abnormal bleeding
研究组 & 干预措施
Non-Bile Collection
On Day 1, all participants will receive a single oral solution dose of 200 mg [14C] BMS-986177 containing approximately 88 micro Ci of total radioactivity (TRA). Participants will remain in the clinical facility until at least Day 7 and will be discharged when release criteria are met or until Day 12
干预措施: BMS-986177 (Drug)
Bile Collection
On Day 1, all participants will receive a single oral solution dose of 200 mg [14C] BMS-986177 containing approximately 88 micro Ci of total radioactivity (TRA). Approximately 1 hour after study drug administration, an ND tube may be positioned in approximately 3 selected participants for collection of bile.Participants will remain in the clinical facility until at least Day 7 and will be discharged when release criteria are met or until Day 12
干预措施: BMS-986177 (Drug)
结局指标
主要结局
Assess PK Cmax of a dose of [14C]BMS-986177
时间窗: Day 1-12
Cmax
Assess PK AUC(INF) of a dose of [14C]BMS-986177
时间窗: Day 1-12
AUC(INF)
Assess PK AUC(0-T) of a dose of [14C]BMS-986177
时间窗: Day 1-12
AUC(0-T)
Assess PK Tmax of a dose of [14C]BMS-986177
时间窗: Day 1-12
Tmax
Assess PK T-HALF of a dose of [14C]BMS-986177
时间窗: Day 1-12
T-HALF
Assess PK CL/F of a dose of [14C]BMS-986177
时间窗: Day 1-12
Assess PK Vz/F of a dose of [14C]BMS-986177
时间窗: Day 1-12
Vz/F
Assess PK AUC of a dose of [14C]BMS-986177
时间窗: Day 1-12
AUC(BMS-986177)
Assess PK AUC(TRA) of a dose of [14C]BMS-986177
时间窗: Day 1-12
AUC(TRA)
Assess PK Plasma AUC(TRA) of a dose of [14C]BMS-986177
时间窗: Day 1-12
Plasma AUC(TRA)
Assess PK Blood AUC(TRA) of a dose of [14C]BMS-986177
时间窗: Day 1-12
Blood AUC(TRA)
Assess the CLR of [14C]BMS-986177
时间窗: Day 1-12
CLR
Assess the %UR of [14C]BMS-986177
时间窗: Day 1-12
%UR
Assess the %FE of [14C]BMS-986177
时间窗: Day 1-12
%FE
Assess the %BE of [14C]BMS-986177
时间窗: Day 1-12
%BE (if applicable)
Assess the %Total recovery of [14C]BMS-986177
时间窗: Day 1-12
%Total recovery
次要结局
- Asess the Incidence of AEs of a single oral dose of 200 mg [14C] BMS-986177(Day 1-12)
- Asess the Incidence of SAEs of a single oral dose of 200 mg [14C] BMS-986177(Day 1-12)
- Asess the Incidence of AEs leading to discontinuation of a single oral dose of 200 mg [14C] BMS-986177(Day 1-12)
- Assess the vital signs of a subject dosed with single oral dose of 200 mg [14C] BMS-986177(Day 1-12)
- Assess the ECGs of subjects dosed with single oral dose of 200 mg [14C] BMS-986177(Day 1-12)
- Assess the clinical lab tests of a single oral dose of 200 mg [14C] BMS-986177(Day 1-12)