Clofutriben Pharmacokinetics in Patients With Impaired Renal Function
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- 1. Maximum plasma concentration (Cmax)
研究概览
简要总结
This is a Phase 1, single-center, open-label, single-dose trial. Sixteen participants are planned: 8 participants with moderate renal impairment and 8 matched control participants with normal renal function.
详细描述
Following Screening, enrolled participants will be confined to a clinical research unit for 6 days. Each participant will receive a single oral dose of clofutriben. Clofutriben PK, safety, and tolerability will be assessed. The participants will be contacted by telephone 4 weeks after clofutriben administration for safety follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 83 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female participants with stable moderate renal impairment (estimated glomerular filtration rate [eGFR]: 30 to <60 mL/min) and matched (by sex, age, and weight) control participants with normal renal function (eGFR: ≥90 mL/min) will be enrolled in this trial.
排除标准
- •Participant whose current or recent medical conditions, medications, or procedures could increase participant's safety risk, or whom the Investigator considers not suitable for entry into the trial or the participant, or who has clinically significant abnormal 12-lead electrocardiogram (ECG)/ vital sign measurements/ laboratory test results at Screening and Check-in, will not be enrolled
研究组 & 干预措施
clofutriben
干预措施: 12mg clofutriben (Drug)
结局指标
主要结局
1. Maximum plasma concentration (Cmax)
时间窗: from enrollment through treatment for 6 days.
Conclusions that clofutriben and AS2570469 exposures (separately) are not altered by moderate renal impairment will be reached if the 95% CIs of the geometric mean estimates of AUC0-t, AUC0-inf, and Cmax of clofutriben and AS2570469 fall within the \[60%, 140%\] range.
2. Area under the plasma time-concentration curve (AUC0-t, AUC0-inf)
时间窗: from enrollment through treatment for 6 days.
Conclusions that clofutriben and AS2570469 exposures (separately) are not altered by moderate renal impairment will be reached if the 95% CIs of the geometric mean estimates of AUC0-t, AUC0-inf, and Cmax of clofutriben and AS2570469 fall within the \[60%, 140%\] range.
次要结局
未报告次要终点