A Phase 1, Open-label Study to Assess the Pharmacokinetics and Safety of a Single Dose of Inaxaplin in Subjects With Mild or Moderate Hepatic Impairment and in Matched Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of IXP
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of Inaxaplin (IXP) in participants with mild or moderate hepatic impairment and in matched 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 75 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 Hepatic Impairment
- •Cohort 1 (mild impairment): defined as a Child-Pugh total score of 5 to 6 (Child-Pugh Class A)
- •Cohort 3 (moderate impairment): defined as a Child-Pugh total score of 7 to 9 (Child-Pugh Class B)
- •Cohorts 2 and 4: Healthy Participants
- •Participants will be matched during screening to participants with mild (Cohort 1) or moderate (Cohort 3) hepatic impairment according to each of the following parameters: age (± 10 years); sex; and BMI (± 15%)
排除标准
- •Cohorts 1 and 3: Participants with Hepatic Impairment
- •Acute febrile illness within 14 days and/or acute illness within 5 days before first dose of study drug
- •Participants who smoke
- •Cohorts 2 and 4: Healthy Participants
- •Acute febrile illness within 14 days and/or acute illness within 5 days before first dose of study drug
- •Any condition possibly affecting drug absorption
- •Other protocol defined Inclusion/Exclusion criteria may apply
研究组 & 干预措施
Cohort 1: Mild Hepatic Impairment
Participants will receive a single dose of IXP on Day 1.
干预措施: IXP (Drug)
Cohort 2: Matched Healthy Participants
Healthy participants matched to Cohort 1 will receive a single dose of IXP on Day 1.
干预措施: IXP (Drug)
Cohort 3: Moderate Hepatic Impairment
Participants will receive a single dose of IXP on Day 1.
干预措施: IXP (Drug)
Cohort 4: Matched Healthy Participants
Healthy participants matched to Cohort 3 will receive a single dose of IXP on Day 1.
干预措施: IXP (Drug)
结局指标
主要结局
Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of IXP
时间窗: From Day 1 up to Day 10
Maximum Observed Plasma Concentration (Cmax) of IXP
时间窗: From Day 1 up to Day 10
次要结局
- Safety and Tolerability as Assessed by Number of Participants With Adverse events (AEs) and Serious Adverse Events (SAEs)(From Day 1 up to Day 20)