A Phase 1, 3-Part, Open-label Study to Assess the Pharmacokinetic Interaction Between BMS-986278 and Nintedanib, the Relative Bioavailability of BMS-986278 Tablet Formulations, and the Food Effect on the Pharmacokinetics of BMS-986278 When Orally Administered as a Phase 3 Tablet Formulation in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Maximum Observed Serum Concentration (Cmax)
研究概览
简要总结
The Purpose of the Study is to Assess the Drug Interaction and Bioavailability of BMS-986278 in Tablet Formulations and the Effect that Food has on BMS-986278 in Tablet Formulation in Healthy Participants
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be healthy males and females (INOCBP)
- •Participant must have Body mass index (BMI) of 18.0 kg/m2 through 32.0 kg/m2, inclusive.
- •Participant must have Body weight ≥ 50 kg
排除标准
- •Participant must not have current or recent GI disease
- •Participant with evidence of organ dysfunction or any clinically significant deviation, as determined by investigator, from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory determinations beyond what is consistent with the target population.
- •Participant with prior exposure to BMS-986278 and exposure of any investigational drug or placebo within 4 weeks of study intervention administration.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Part I: Period A
干预措施: Nintedanib (Drug)
Part I: Period B
干预措施: BMS 986278 (Drug)
Part I: Period C
干预措施: Nintedanib (Drug)
Part I: Period C
干预措施: BMS 986278 (Drug)
Part II: Period 1
干预措施: BMS 986278 (Drug)
Part II: Period 2
干预措施: BMS 986278 (Drug)
Part II: Period 3
干预措施: BMS 986278 (Drug)
Part III: Period 1
干预措施: BMS 986278 (Drug)
Part III: Period 2
干预措施: BMS 986278 (Drug)
结局指标
主要结局
Maximum Observed Serum Concentration (Cmax)
时间窗: Days 4, 17, 21 (Part-1); Days 1, 7, 13 (Part-2); Days 1, 7 (Part-3)
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T)
时间窗: Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)
Area under the plasma concentration-time curve within a dosing interval AUC(TAU)
时间窗: Day 4, 17 and 21 of Part 1
Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF)
时间窗: Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)
次要结局
- Number of participants with vital sign abnormalities(Up to 28 Days post discontinuation of dosing)
- Number of participants with clinical laboratory abnormalities(Up to 28 Days post discontinuation of dosing)
- Number of participants with non-serious AEs (Adverse events)(Up to 28 Days post discontinuation of dosing)
- Number of participants with Physical examination abnormalities(Up to 28 Days post discontinuation of dosing)
- Apparent terminal phase half-life (T-HALF)(Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2))
- Number of participants with AEs leading to discontinuation(Up to 28 Days post discontinuation of dosing)
- Apparent total body clearance (CLT/F)(Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2))
- Number of participants with Serious AEs(Up to 28 Days post discontinuation of dosing)
- Number of participants with 12-lead electrocardiogram (ECG) abnormalities(Up to 28 Days post discontinuation of dosing)
- Time of maximum observed plasma concentration (Tmax)(Day 4, 17, 21 (Part-1), Day 1 (part-2 and Part-3), Day 7 (Part2 and 3), Day 13) (Part-2))
- Apparent volume of distribution of terminal phase (Vz/F)(Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2))