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

Shionogi4 个研究点分布在 1 个国家目标入组 32 人开始时间: 2022年8月10日最近更新: 2023年4月24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: 32
试验地点: 4
主要终点: Apparent Total Clearance (CL/F) 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 measure the PK, safety, and tolerability of S-217622 in participants with mild, moderate, or severe renal impairment and in those with normal renal 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 Renal Impairment
•Participants that are not undergoing dialysis must have mild, moderate, or severe renal impairment based upon their Modification of Diet in Renal Disease (MDRD) creatinine clearance estimate (estimated glomerular filtration rate [eGFR]) calculated at the Screening visit:
•Mild renal impairment: 60 to 89 milliliters per minute (mL/min)/1.73 m^2
•Moderate renal impairment: 30 to 59 mL/min/1.73 m^2
•Severe renal impairment: No lower limit of eGFR, <30 mL/min
•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
•Participants with clinical laboratory tests within normal reference range for the laboratory, or abnormal but considered not clinically significant by the investigator. Renal function, calculated by MDRD, must be normal (ie, eGFR > 90 mL/min/1.73 m^2).
•Matched to each participant with moderate renal impairment with respect to sex, age (± 5 years), and BMI (± 10%).

排除标准

•Participants with life expectancy less than 3 months.
•History or presence of/significant history of or current cardiovascular, respiratory, hepatic, 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.
•Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
•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.

研究组 & 干预措施

S-217622: Group A

Experimental

Participants with mild renal 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 renal 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 C

Experimental

Participants with severe renal 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 D

Experimental

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

干预措施: S-217622 (Drug)