NCT03713242已完成1 期
A Single-center, Open-label, Single-dose, Phase 1 Study to Evaluate the Pharmacokinetics of ACT-541468 in Subjects With Mild, Moderate, and Severe Hepatic Impairment
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Treatment-emergent adverse events (AEs)
研究概览
简要总结
This is a prospective, single-center, open-label, single-dose, Phase 1 study, to assess the effect of mild, moderate, and severe hepatic impairment due to liver cirrhosis on the pharmacokinetics of ACT-541468.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 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
- 否
入选标准
- •Signed informed consent prior to any study-mandated procedure.
- •Male and female subjects aged between 18 and 75 years (inclusive) at screening.
- •Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day -
- •They must consistently and correctly use (from screening, during the entire study, and for at least one month after last study treatment intake) a highly effective method of contraception, be sexually inactive, or have a vasectomized partner.
- •Women of non-childbearing potential.
- •Body mass index of 18.0 to 35.0 kg/m2 (inclusive) at screening.
- •For healthy subjects: Normal renal function confirmed by a creatinine clearance at screening according to Cockroft and Gault adjusted to age of:
- •≥ 80 mL/min/1.73 m2 for subjects ≤ 50 years of age.
- •≥ 70 mL/min/1.73 m2 for subjects 51-60 years of age.
- •≥ 60 mL/min/1.73 m2 for subjects 61-75 years of age.
- •For subjects with hepatic impairment: Degree of liver function impairment due to liver cirrhosis according to the Child-Pugh classification:
- •Group A: Mild hepatic impairment, Child-Pugh score 5-
- •Group B: Moderate hepatic impairment, Child-Pugh score 7-
- •Group C: Severe hepatic impairment, Child-Pugh score 10-15.
排除标准
- •Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
- •For subjects with hepatic impairment: History of major medical or surgical disorders, which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment except for those related to liver cirrhosis (appendectomy and herniotomy allowed, cholecystectomy not allowed).
- •For healthy subjects:
- •History of alcoholism or drug abuse within the 3-year period prior to screening.
- •Relevant history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
研究组 & 干预措施
Group A: ACT-541468 in subjects with mild hepatic impairment
Experimental
Single oral dose administered on Day 1.
干预措施: ACT-541468 25 mg (Drug)
Group B: ACT-541468 in subj. with moderate hepatic impairment
Experimental
Single oral dose administered on Day 1.
干预措施: ACT-541468 25 mg (or 10 mg depending on interim results) (Drug)
Group C: ACT-541468 in subjects with severe hepatic impairment
Experimental
Single oral dose administered on Day 1.
干预措施: ACT-541468 25 mg (or 10 mg depending on interim results) (Drug)
Group D: ACT-541468 in healthy subjects.
Experimental
Single oral dose administered on Day 1.
干预措施: ACT-541468 25 mg (or 10 mg depending on interim results) (Drug)
结局指标
主要结局
Treatment-emergent adverse events (AEs)
时间窗: From study treatment administration up to EOS (duration: up to 4 days)
Treatment-emergent serious adverse events (SAEs)
时间窗: From study treatment administration up to EOS (duration: up to 4 days)
次要结局
未报告次要终点
研究者
研究点 (1)
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