NCT05515445已完成1 期
Study to Evaluate the Pharmacokinetics of Chiglitazar in Subjects With Hepatic Impairment and Normal Hepatic Function
Chipscreen Biosciences, Ltd.1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年12月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
This Phase 1 open label study is being conducted to directly characterize the pharmacokinetic (PK) profiles of Chiglitazar following administration of a single oral dose in subjects with varying degrees of hepatic impairment compared to subjects 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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntarily sign informed consent, able to comply with the requirements of the study.
- •Male or female, between 18 and 79 years of age.
- •Weight of male ≥50 kg and Weight of female ≥ 45 kg.
- •No medication within 2 weeks, or stable medication for at least 4 weeks prior to screening.
- •Physical examination, vital signs examination, 12-lead electrocardiogram (ECG) examination, and laboratory test have been determined by the investigator to be suitable for participating in this trial.
排除标准
- •Allergic constitution, or allergic to PPAR agonist drugs or any component of Chiglitazar tablets.
- •received PPAR agonist drugs within 2 weeks before screening.
- •Those who have been vaccinated within 4 weeks before screening, or who plan to be vaccinated during the trial.
- •positive test for COVID-19, TP antibody and RPR, or HIV antibody.
- •suffer from uncontrolled serious diseases of cardiovascular, respiratory, gastrointestinal, endocrine, blood, mental/nervous systems within 1 year before screening.
- •have previously undergone surgery that may affect the absorption, distribution, metabolism, and excretion of drugs; anticipate surgery or hospitalization during the trial.
- •Drug abusers, or positive test for drugs of abuse.
- •Smoking more than 5 cigarettes per day on average within 3 months before screening.
- •The average daily alcohol intake in the 3 months prior to screening exceeds the following criteria: more than 14 g for women, or more than 28 g for men; ingested any products containing alcohol within 48 hours before administration; positive alcohol breath test; patients with alcoholic cirrhosis who did not abstinence within 3 months before screening.
- •Ingestion of grapefruit juice/grapefruit juice, food or drink rich in methylxanthine within 48 hours before administration; strenuous exercise or other factors that affect drug absorption, distribution, metabolism, excretion.
- •participated in clinical trials of any drug or medical device within 3 months before screening.
- •donated blood (or blood loss) ≥400 mL within 3 months before screening, or received whole blood or red blood cell suspension.
- •Female subjects who are breastfeeding or positive test of serum pregnancy.
- •eGFR<60 mL/min/1.73m
- •Other circumstances assessed by the investigator are not suitable for participating in this trial.
- •Supplementary exclusion criteria for subjects with hepatic impairment：
- •drug-induced liver injury.
- •acute liver function damage caused by various reasons;
- •complications of liver cirrhosis that the investigator considers inappropriate to participate in the study.
- •diseases that seriously affect bile excretion.
- •Supplementary exclusion criteria for subjects with normal hepatic function:
- •history of hepatic function damage, or who may have hepatic function damage that the investigator considers to be clinically significant.
- •positive test for HBsAg, HCV.
研究组 & 干预措施
Normal Hepatic Function
Experimental
Subjects with normal hepatic function will receive a single 48 mg oral dose of Chiglitazar
干预措施: Chiglitazar (Drug)
Mild Hepatic Impairment
Experimental
Subjects with mild hepatic impairment will receive a single 48 mg oral dose of Chiglitazar
干预措施: Chiglitazar (Drug)
Moderate Hepatic Impairment
Experimental
Subjects with moderate hepatic impairment will receive a single 48 mg oral dose of Chiglitazar
干预措施: Chiglitazar (Drug)
Severe Hepatic Impairment
Experimental
Subjects with severe hepatic impairment will receive a single 48 mg oral dose of Chiglitazar
干预措施: Chiglitazar (Drug)
结局指标
主要结局
Cmax
时间窗: 4 days
Maximum plasma concentration
AUC0-t and AUC0-inf
时间窗: 4 days
Area under of the curve (AUC0-t and AUC0-inf)
次要结局
未报告次要终点
研究者
研究点 (1)
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