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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatic Impairment
• Intervention / Treatment: Drug: Chiglitazar

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China
      • The First Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Chipscreen Biosciences, Ltd.
• Investigators: Principal Investigator: Liyan Miao, First Affiliated Hospital of Suzhou Medical College

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2022
• Primary Completion (Actual): August 23, 2023
• Study Completion (Actual): August 23, 2023

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (Actual): August 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 24, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: CGZ108

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No