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

Phase 1

Completed

• Conditions: Hepatic Impairment
• Interventions: Drug: Chiglitazar

• Registration Number: NCT05515445
• Lead Sponsor: Chipscreen Biosciences, Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-08-23
• Study First Posted: 2022-08-25
• Study Start: 2022-12-03
• Primary Completion: 2023-08-23
• Study Completion: 2023-08-23
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-24
• Last Update Posted: 2024-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Severe Hepatic Impairment	Chiglitazar	Subjects with severe hepatic impairment will receive a single 48 mg oral dose of Chiglitazar
Normal Hepatic Function	Chiglitazar	Subjects with normal hepatic function will receive a single 48 mg oral dose of Chiglitazar
Mild Hepatic Impairment	Chiglitazar	Subjects with mild hepatic impairment will receive a single 48 mg oral dose of Chiglitazar
Moderate Hepatic Impairment	Chiglitazar	Subjects with moderate hepatic impairment will receive a single 48 mg oral dose of Chiglitazar

Primary Outcome Measures

Name	Time	Method
Cmax	4 days	Maximum plasma concentration
AUC0-t and AUC0-inf	4 days	Area under of the curve (AUC0-t and AUC0-inf)

Trial Locations

Locations (1)

the First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China