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

Hepatic Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05515445
• Other study ID #: CGZ108
• Status: Completed
• Phase: Phase 1
• Start date: December 3, 2022
• Est. completion date: August 23, 2023

Study information

• Verified date: May 2024
• Source: Chipscreen Biosciences, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 23, 2023
• Est. primary completion date: August 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• Chiglitazar
Oral single dose 48 mg

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Chipscreen Biosciences, Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Maximum plasma concentration	4 days
Primary	AUC0-t and AUC0-inf	Area under of the curve (AUC0-t and AUC0-inf)	4 days