Effect of BMS-986020 on the Pharmacokinetics of Montelukast, Flurbiprofen, and Digoxin as Probe Substrates for CYP2C8, CYP2C9, and P-gp
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters (maximum observed plasma concentration, area under the concentration-time curve) for montelukast, flurbiprofen, and digoxin
研究概览
简要总结
This is an open-label, single-sequence, drug-drug interaction study in healthy male and female subjects. There is no formal research hypothesis to be statistically tested. It is expected that coadministration of BMS-986020 with montelukast, flurbiprofen, and digoxin may increase the exposure of montelukast, flurbiprofen, and digoxin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female nonsmoking subjects ages 18 to 50 years, inclusive, with a body mass index of 18.0 to 32.0 kg/m2, inclusive
- •Women of childbearing potential must agree to follow instructions for methods of contraception for the duration of the study
排除标准
- •Any significant acute or chronic medical illness
- •History of arrhythmias or palpitations associated with dizziness or fainting
- •History of clinically relevant cardiac disease
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
Single-Sequence, A B C
Treatment A:
Single oral dose of montelukast, flurbiprofen, and digoxin on Day 1
Treatment B:
BMS-986020 orally twice daily (BID) on Day 8 through Day 10
Treatment C:
BMS-986020 orally BID, single oral dose of montelukast, flurbiprofen, and digoxin on Day 11; BMS-986020 BID on Day 12 through Day 17
干预措施: BMS-986020 (Drug)
Single-Sequence, A B C
Treatment A:
Single oral dose of montelukast, flurbiprofen, and digoxin on Day 1
Treatment B:
BMS-986020 orally twice daily (BID) on Day 8 through Day 10
Treatment C:
BMS-986020 orally BID, single oral dose of montelukast, flurbiprofen, and digoxin on Day 11; BMS-986020 BID on Day 12 through Day 17
干预措施: Montelukast (Drug)
Single-Sequence, A B C
Treatment A:
Single oral dose of montelukast, flurbiprofen, and digoxin on Day 1
Treatment B:
BMS-986020 orally twice daily (BID) on Day 8 through Day 10
Treatment C:
BMS-986020 orally BID, single oral dose of montelukast, flurbiprofen, and digoxin on Day 11; BMS-986020 BID on Day 12 through Day 17
干预措施: Flurbiprofen (Drug)
Single-Sequence, A B C
Treatment A:
Single oral dose of montelukast, flurbiprofen, and digoxin on Day 1
Treatment B:
BMS-986020 orally twice daily (BID) on Day 8 through Day 10
Treatment C:
BMS-986020 orally BID, single oral dose of montelukast, flurbiprofen, and digoxin on Day 11; BMS-986020 BID on Day 12 through Day 17
干预措施: Digoxin (Drug)
结局指标
主要结局
Pharmacokinetic parameters (maximum observed plasma concentration, area under the concentration-time curve) for montelukast, flurbiprofen, and digoxin
时间窗: Predose and up to 168 hours post dose
Pharmacokinetic endpoints for montelukast, flurbiprofen, and digoxin with and without BMS-986020
次要结局
- Safety(From dosing (Day 1) to Day 21)
- Additional pharmacokinetic parameters for montelukast, flurbiprofen, and digoxin.(Predose and up to 168 hour post dose)