A Phase 1, Open-label, Parallel-group Study to Assess the Pharmacokinetics, Safety, and Tolerability of S-217622 in Participants With Mild and Moderate Hepatic Impairment and Healthy Control Participants

Shionogi4 个研究点分布在 1 个国家目标入组 25 人开始时间: 2022年9月13日最近更新: 2023年5月26日

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: 25
试验地点: 4
主要终点: Area Under the Plasma Concentration-Time Curve (AUC) of S-217622

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective of this study is to assess the pharmacokinetics (PK), safety, and tolerability of S-217622 in participants with mild and moderate hepatic impairment compared with 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: 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

•Body weight ≥50 kilograms (kg) and body mass index (BMI) within the range of ≥18.5 to <38.0 kilogram-meter squared (kg/m^2) at the Screening visit.
•Participants With Hepatic Impairment
•A diagnosis of clinically stable hepatic disease for at least 1 month prior to the Screening visit, confirmed by medical history or previous confirmation of hepatic cirrhosis by liver biopsy or medical imaging technique (including laparoscopy, computerized tomography [CT] scan, magnetic resonance imaging [MRI], or ultrasonography).
•Mild or moderate hepatic impairment based on the Child-Pugh classification score at the Screening visit to determine eligibility:
•Mild (Class A) hepatic impairment (Child-Pugh classification score 5 to 6)
•Moderate (Class B) hepatic impairment (Child-Pugh classification score 7 to 9)
•A stable medication regimen is required, defined as not starting new drug(s) or changing dosage(s) within 14 days prior to administration of study intervention through the Follow-up/Early Termination visit.
•Healthy Participants
•Matched to each participant with moderate (and mild when possible) hepatic impairment with respect to sex, age (± 5 years), and BMI (± 10%).

排除标准

•History or presence of/significant history of or current cardiovascular, respiratory, renal, gastrointestinal (GI), endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
•History of GI surgery including but not limited to gastric resection and/or intestinal resection that resulted in a clinically significant abnormality in GI function.
•Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
•Breast cancer within the past 10 years.
•Participant with poor venous access.
•Other inclusion and exclusion criteria may apply.

研究组 & 干预措施

S-217622: Group C

Experimental

Participants with normal hepatic function will receive a single dose of S-217622 on Day 1, in a fasted state.

干预措施: S-217622 (Drug)

S-217622: Group A

Experimental

Participants with mild hepatic impairment will receive a single dose of S-217622 on Day 1, in a fasted state.

干预措施: S-217622 (Drug)

S-217622: Group B

Experimental

Participants with moderate hepatic impairment will receive a single dose of S-217622 on Day 1, in a fasted state.

干预措施: S-217622 (Drug)