pharmacokinetics of chiglitazar in subjects with hepatic impairment and normal hepatic function

Conditions: Hepatic Impairment

Summary: 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.


Eligibility criteria:
inclusion criteria: * voluntarily sign informed consent, able to comply with the requirements of the study. * male or female, between 18 and 79 years of age. * 18≤bmi≤30. 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. exclusion criteria: * 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/1.73m2. * 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.