Pharmacokinetics of Chiglitazar in Subjects With Hepatic Impairment and Normal Hepatic Function

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Hepatic Impairment

Intervention / Treatment
-----------------
* Drug: Chiglitazar


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal Hepatic Function<br>Subjects with normal hepatic function will receive a single 48 mg oral dose of Chiglitazar | Drug: Chiglitazar<br>* Oral single dose 48 mg<br>|
| Experimental: Mild Hepatic Impairment<br>Subjects with mild hepatic impairment will receive a single 48 mg oral dose of Chiglitazar | Drug: Chiglitazar<br>* Oral single dose 48 mg<br>|
| Experimental: Moderate Hepatic Impairment<br>Subjects with moderate hepatic impairment will receive a single 48 mg oral dose of Chiglitazar | Drug: Chiglitazar<br>* Oral single dose 48 mg<br>|
| Experimental: Severe Hepatic Impairment<br>Subjects with severe hepatic impairment will receive a single 48 mg oral dose of Chiglitazar | Drug: Chiglitazar<br>* Oral single dose 48 mg<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum plasma concentration | 4 days | 
| AUC0-t and AUC0-inf | Area under of the curve (AUC0-t and AUC0-inf) | 4 days |