NCT03981094已完成1 期
An Open Label Study to Assess the Pharmacokinetic Interaction Between Pirfenidone and BMS-986278 Following a Single Oral Dose Administration in Healthy Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2019年5月10日最近更新:
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
- 22
- 试验地点
- 1
- 主要终点
- Maximum observed serum concentration (Cmax) of BMS-986278 and pirfenidone alone or in combination
研究概览
简要总结
The main objectives of this study are to characterize the PK of BMS-986278 after administration of a single dose of BMS-986278 alone or in combination with pirfenidone, as well as to characterize the PK of pirfenidone after administration of a single dose of pirfenidone alone or in combination with BMS-986278
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed Informed Consent.
- •Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
排除标准
- •Women of child bearing potentia (WOCBP), pregnant or breastfeeding.
- •History of significant cardiovascular disease.
- •Participants who have smoked or used smoking cessation or nicotine containing products within 3 months of the first dose of study.
- •Other protocol defined inclusion/exclusion criteria could apply.
研究组 & 干预措施
BMS-986278 + Pirfenidone
Experimental
干预措施: BMS-986278 (Drug)
BMS-986278 + Pirfenidone
Experimental
干预措施: Pirfenidone (Drug)
Pirfenidone
Experimental
干预措施: Pirfenidone (Drug)
BMS-986278
Experimental
干预措施: BMS-986278 (Drug)
结局指标
主要结局
Maximum observed serum concentration (Cmax) of BMS-986278 and pirfenidone alone or in combination
时间窗: Up to day 5 of each period (Each period is 7 days; 3 periods total)
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986278 and pirfenidone alone or in combinaton
时间窗: Up to day 5 of each period (Each period is 7 days; 3 periods total)
Area under the plasma concentration-time curve extrapolated to infinity [(AUC(INF)] of BMS-986278 and pirfenidone alone or in combinaton
时间窗: Up to day 5 of each period (Each period is 7 days; 3 periods total)
次要结局
- Number of Participants With Clinically Significant Change in Physical Examination(Up to Day 8 of Period 3 (each period is 7 days; 3 periods total))
- Volume of distribution at terminal phase (VzF) of BMS-986278 and metabolite alone or in combination with pirfenidone(Up to Day 5 of period 3 (each period is 7 days; 3 periods total))
- Oral clearance (CL/F) of BMS-986278 and metabolite alone or in combination with pirfenidone(Up to Day 5 of period 3 (each period is 7 days; 3 periods total))
- Time of maximum observed serum concentration (Tmax) of BMS-986278 and metabolite alone or in combination with pirfenidone(Up to Day 5 of period 3 (each period is 7 days; 3 periods total))
- Incidence of AEs (adverse events), SAEs (serious adverse events), and AEs leading to discontinuation(Up to Day 8 of Period 3 (each period is 7 days; 3 periods total))
- Number of Participants With Clinically Significant Change in Clinical Laboratory Values(Up to Day 8 of Period 3 (each period is 7 days; 3 periods total))
- Number of Participants With Clinically Significant Change in Vital Signs(Up to Day 8 of Period 3 (each period is 7 days; 3 periods total))
- Number of Participants With Clinically Significant Change in Electrocardiogram (ECG)(Up to Day 8 of Period 3 (each period is 7 days; 3 periods total))
- Elimination half-life (T-HALF) of BMS-986278 and metabolite alone or in combination with pirfenidone(Up to Day 5 of period 3 (each period is 7 days; 3 periods total))
- Time of maximum observed serum concentration (Tmax) of pirfenidone and metabolite alone or in combination with BMS-986278(Up to Day 5 of Period 3 (each period is 7 days; 3 periods total))
- Elimination half-life (T-HALF) of pirfenidone and metabolite alone or in combination with BMS-986278(Up to Day 5 of Period 3 (each period is 7 days; 3 periods total))
- Volume of distribution at terminal phase (VzF) Plasma Pharmokinetics of pirfenidone and metabolite alone or in combination with BMS-986278(Up to Day 5 of Period 3 (each period is 7 days; 3 periods total))
- Renal clearance (Clr) in Urine of pirfenidone alone or in combination with BMS-986278(Up to Day 5 of Period 3 (each period is 7 days; 3 periods total))
- Cumulative amount recovered in urine [Ae(0-T)] of pirfenidone alone or in combination with BMS-986278(Up to Day 5 of Period 3 (each period is 7 days; 3 periods total))
- Oral clearance (CL/F) of pirfenidone and metabolite alone or in combination with BMS-986278(Up to Day 5 of Period 3 (each period is 7 days; 3 periods total))
研究者
研究点 (1)
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