Study to Evaluate the Pharmacokinetics of Chiglitazar in Subjects With Hepatic Impairment and Normal Hepatic Function

CGZ108

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.

2022-11-22

2023-10-30

2023-10-30

Recruiting

Early phase I

44

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 44, 'type': 'ESTIMATED'}}

2023-08-30