A Phase 1, Open-label Study Evaluating the Effect of VX-993 on the Pharmacokinetics of Midazolam, and the Effect of Itraconazole and Gemfibrozil on the Pharmacokinetics of VX-993, in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Part A: Area Under the Concentration Versus Time Curve (AUC) of Midazolam in Absence and Presence of VX-993
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics (PK), drug-drug interaction, and safety and tolerability of VX-993 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
- Treatment
- 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 of more than (>) 50 kg
- •Nonsmoker or ex-smoker for at least 3 months before the first study drug dose
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, distribution, metabolism, or excretion
- •Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Part A: Midazolam
Participants will receive a single dose of Midazolam in absence and presence of VX-993.
干预措施: VX-993 (Drug)
Part A: Midazolam
Participants will receive a single dose of Midazolam in absence and presence of VX-993.
干预措施: Midazolam (Drug)
Part B: Itraconazole
Participants will receive a single dose of VX-993 on Day 1 and Itraconazole once daily (qd) on Days 7 through Day 15. On Day 10 participants will receive Itraconazole followed by VX-993.
干预措施: VX-993 (Drug)
Part B: Itraconazole
Participants will receive a single dose of VX-993 on Day 1 and Itraconazole once daily (qd) on Days 7 through Day 15. On Day 10 participants will receive Itraconazole followed by VX-993.
干预措施: Itraconazole (Drug)
Part C: Gemfibrozil
Participants will receive a single dose of VX-993 on Day 1 and Gemfibrozil every 12 hours (q12d) on Days 7 through Day 15. On Day 10 participants will receive Gemfibrozil followed by VX-993.
干预措施: VX-993 (Drug)
Part C: Gemfibrozil
Participants will receive a single dose of VX-993 on Day 1 and Gemfibrozil every 12 hours (q12d) on Days 7 through Day 15. On Day 10 participants will receive Gemfibrozil followed by VX-993.
干预措施: Gemfibrozil (Drug)
结局指标
主要结局
Part A: Area Under the Concentration Versus Time Curve (AUC) of Midazolam in Absence and Presence of VX-993
时间窗: Pre-dose up to Day 15
Part A: Maximum Observed Plasma Concentration (Cmax) of Midazolam in Absence or Presence of VX-993
时间窗: Pre-dose up to Day 15
Part A: Maximum Observed Plasma Concentration (Cmax) of 1-Hydroxy-Midazolam in Absence or Presence of VX-993
时间窗: Pre-dose up to Day 15
Part A: Area Under the Concentration Versus Time Curve (AUC) of 1-Hydroxy-Midazolam in Absence and Presence of VX-993
时间窗: Pre-dose up to Day 15
Part B: Maximum Observed Plasma Concentration (Cmax) of VX-993 in Absence or Presence of Itraconazole
时间窗: Pre-dose up to Day 27
Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-993 in Absence or Presence of Itraconazole
时间窗: Pre-dose up to Day 27
Part C: Area Under the Concentration Versus Time Curve (AUC) of VX-993 in Absence or Presence of Gemfibrozil
时间窗: Pre-dose up to Day 27
Part C: Maximum Observed Plasma Concentration (Cmax) of VX-993 in Absence or Presence of Gemfibrozil
时间窗: Pre-dose up to Day 27
次要结局
- Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(From Day 1 up to Day 30)
- Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(From Day 1 up to Day 27)
- Part C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(From Day 1 up to Day 27)