A Phase 1, Open-label Drug-drug Interaction Study to Evaluate the Effects of Omeprazole and Rifampin on the Pharmacokinetics of VX-548 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Part B: Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite in the Absence and Presence of Rifampin
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics and safety of VX-548 and its metabolite in the absence and presence of omeprazole or rifampin, in healthy participants.
详细描述
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4) (A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m^2)
- •A total body weight greater than (>) 50 kg
排除标准
- •History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug
- •Any condition possibly affecting drug absorption
- •History of cardiovascular disease
- •Participants of child-bearing potential
- •Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Part A
Participants will receive a single dose of VX-548 on Day 1 and a single dose of omeprazole once daily (qd) on Days 10 through Day 12. On Day 13, participants will receive omeprazole followed by VX-548 under fasted conditions.
干预措施: VX-548 (Drug)
Part A
Participants will receive a single dose of VX-548 on Day 1 and a single dose of omeprazole once daily (qd) on Days 10 through Day 12. On Day 13, participants will receive omeprazole followed by VX-548 under fasted conditions.
干预措施: Omeprazole (Drug)
Part B
Participants will receive a single dose of VX-548 on Day 1 followed by rifampin qd on Days 10 through Day 27. On Day 19, participants will be co-administered rifampin and VX-548 under fasted conditions.
干预措施: VX-548 (Drug)
Part B
Participants will receive a single dose of VX-548 on Day 1 followed by rifampin qd on Days 10 through Day 27. On Day 19, participants will be co-administered rifampin and VX-548 under fasted conditions.
干预措施: Rifampin (Drug)
结局指标
主要结局
Part B: Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite in the Absence and Presence of Rifampin
时间窗: Day 1 up to Day 28
Part B: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548 and its Metabolite in the Absence and Presence of Rifampin
时间窗: Day 1 up to Day 28
Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548 and its Metabolite in the Absence and Presence of Omeprazole
时间窗: Day 1 up to Day 22
Part A: Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite in the Absence and Presence of Omeprazole
时间窗: Day 1 up to Day 22
次要结局
- Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Day 1 through Safety Follow-up Visit (up to 34 days))
- Part A:Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Day 1 through Safety Follow-up Visit (up to 28 days))