A Phase 1, First-in-human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VX-433 and Its Effects on the Pharmacokinetics of Midazolam and Bupropion
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 118
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of VX-433 following single and multiple ascending doses, as well as to assess the effect of VX-433 on the PK of midazolam, bupropion, and hydroxybupropion.
详细描述
The study is being conducted in healthy participants to evaluate the safety, tolerability, and PK of VX-433 (Parts A and B), as well as potential drug-drug interaction (DDI) between VX-433 and midazolam or bupropion (Part C).
Note: 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
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 30.0 kilogram per meter square (kg/m2), inclusive
- •A total body weight of more than (>) 50 kg
- •Nonsmoker or ex-smoker for at least 3 months before screening with current nonsmoking status confirmed by urine or blood cotinine at screening
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
- •For female participants: of childbearing potential, pregnant, breastfeeding, or planning to become pregnant or donate ova during the study or within 90 days after last dose of study drug
- •Other protocol defined Inclusion/Exclusion criteria will apply.
研究组 & 干预措施
Part A: Single Ascending Dose (SAD)
Participants will be randomized to receive a single dose of VX-433.
干预措施: VX-433 (Drug)
Part C: Drug Drug Interaction
Participants will receive a single dose of midazolam and bupropion on Day 1 in Dosing Period 1, followed by VX-433 administration for 17 days (Days 5 through 21) and then midazolam and bupropion on Day 18 in Dosing Period 2.
Part C will be open-label.
干预措施: Bupropion (Drug)
Part A: Placebo
Participants will be randomized to receive placebo matched to VX-433.
干预措施: Placebo (Drug)
Part B: Multiple Ascending Dose (MAD)
Participants will be randomized to receive multiple doses of VX-433.
干预措施: VX-433 (Drug)
Part B: Placebo
Participants will be randomized to receive placebo matched to VX-433.
干预措施: Placebo (Drug)
Part C: Drug Drug Interaction
Participants will receive a single dose of midazolam and bupropion on Day 1 in Dosing Period 1, followed by VX-433 administration for 17 days (Days 5 through 21) and then midazolam and bupropion on Day 18 in Dosing Period 2.
Part C will be open-label.
干预措施: VX-433 (Drug)
Part C: Drug Drug Interaction
Participants will receive a single dose of midazolam and bupropion on Day 1 in Dosing Period 1, followed by VX-433 administration for 17 days (Days 5 through 21) and then midazolam and bupropion on Day 18 in Dosing Period 2.
Part C will be open-label.
干预措施: Midazolam (Drug)