A Phase 1, Open-label Study to Evaluate the Pharmacokinetics and Safety of Single Doses of VX-548 in Subjects With Severe or Moderate Renal Impairment and in Matched Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 7
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of VX-548 and its metabolite in participants with severe or moderate renal impairment and 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cohorts 1 and 3: Participants with Severe or Moderate Renal Impairment
- •Body mass index (BMI) of greater than or equal to (>=)18.0 to less than (<) 40.0 kilogram per square meter (kg/m^2)
- •Stable renal function as pre-defined in the protocol
- •Cohorts 2 and 4: Matched Healthy Participants
- •Healthy participants will be matched to Cohorts 1 and 3 participants according to each of the following parameters: sex, age (±10 years), and BMI (±15%)
排除标准
- •Cohorts 1 and 3: Participants with Severe or Moderate Renal Impairment
- •Hemoglobin less than or equal to (≤) 9.0 gram per deciliter (g/dL) at screening
- •Cohorts 2 and 4: Matched Healthy Participants
- •Prior renal transplantation, prior hemodialysis, or prior peritoneal dialysis
- •All Cohorts:
- •History of febrile or acute illness that has not fully resolved by 14 days before study drug dosing.
- •Any condition possibly affecting drug absorption
- •Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Cohort 1: Severe Renal Impairment
Participants will receive a single dose of VX-548 in a fasted state.
干预措施: VX-548 (Drug)
Cohort 2: Matched Healthy Participants
Healthy participants matched to cohort 1 will receive a single doses of VX-548 in a fasted state.
干预措施: VX-548 (Drug)
Cohort 3: Moderate Renal Impairment
Participants will receive a single dose of VX-548 in a fasted state.
干预措施: VX-548 (Drug)
Cohort 4: Matched Healthy Participants
Healthy participants matched to cohort 3 will receive a single dose of VX-548 in a fasted state.
干预措施: VX-548 (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of VX-548 and its Metabolite
时间窗: Day 1 to Day 14
Area Under the Plasma Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-548 and its Metabolite
时间窗: Day 1 to Day 14
次要结局
- Apparent Renal Clearance of VX-548 and its Metabolite (CLr)(Day 1 to Day 14)
- Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(Day 1 to Day 23)
- Apparent Non-Renal Clearance of VX-548(Day 1 to Day 14)
- Fraction Unbound (fu) for VX-548 and its Metabolite in Plasma(Day 1 to Day 2)
- Unbound Area Under the Concentration Versus Time Curve of VX-548 and its Metabolite(Day 1 to Day 14)
- Apparent Clearance of VX-548(Day 1 to Day 14)