NCT06352528已完成1 期
A Phase 1, Multicenter, Open-label, Single-dose Study to Assess the Pharmacokinetics of Repotrectinib in Healthy Participants and Those With Moderate and Severe Hepatic Impairment
Bristol-Myers Squibb3 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2024年4月29日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
研究概览
简要总结
The purpose of this study is to assess the drug levels of a single oral dose of repotrectinib in participants with moderate and severe HI, and in healthy matched control participants with normal hepatic function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •- Inclusion Criteria for all Participants (Group 1, Group 2, Group 3):.
- •i) Adult female (as assigned at birth) not of childbearing potential or male (as assigned at birth) of any race or ethnicity.
- •ii) Must have a body mass index between 18 and 40 kg/m2 (inclusive) and body weight ≥ 50 kg at the time of signing the ICF.
- •- Inclusion Criteria for Participants with Moderate or Severe Hepatic Impairment (Group 1 and Group 2):.
- •i) Participants have moderate or severe HI or cirrhosis due to chronic hepatic disease and/or prior alcohol use.
- •ii) Participants have moderate (Group 1), or severe (Group 2) HI as defined by Child-Pugh score.
- •- Inclusion Criteria for a Matched Healthy Participant (Group 3):.
- •i) Participant must be free of any clinically significant disease that would interfere with the study evaluations.
- •ii) Participant must have liver-related laboratory test results within the respective reference ranges or with clinically insignificant excursions therefrom as agreed by the investigator.
- •iii) Participant must be in good health as determined by past medical history, physical examination, vital signs, ECG, and clinical laboratory safety tests. Clinical laboratory safety tests (eg, hematology, chemistry, and urinalysis) and 12-lead ECGs must be within normal limits or clinically acceptable as judged by the investigator.
排除标准
- •- Exclusion Criteria for all Participants (Group 1, Group 2, and Group 3):.
- •i) Any major surgery within 4 weeks of the study intervention administration.
- •ii) History of drug abuse within 1 year of study intervention administration.
- •iii) History of alcohol abuse within 1 year of study intervention administration.
- •iv) Participants who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day
- •- Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Group 1: Moderate Hepatic Impairment
Experimental
干预措施: Repotrectinib (Drug)
Group 2: Severe Hepatic Impairment
Experimental
干预措施: Repotrectinib (Drug)
Group 3: Normal Hepatic Function
Experimental
干预措施: Repotrectinib (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
时间窗: Days 1 to 11
Maximum observed plasma concentration (Cmax)
时间窗: Days 1 to 11
Time of maximum observed plasma concentration (Tmax)
时间窗: Days 1 to 11
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
时间窗: Days 1 to 11
次要结局
- Number of participants with Adverse Events (AEs)(Up to 28 days following last dose)
- Number of participants with Severe Adverse Events (SAEs)(Up to 28 days following last dose)
- Number of participants with physical examination abnormalities(Up to Day 11)
- Number of participants with vital sign abnormalities(Up to Day 11)
- Number of participants with clinical safety laboratory test abnormalities(Up to Day 11)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to Day 11)
研究者
研究点 (3)
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