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

NCT05515445 | Completed Phase 1

• 1 other identifier: CGZ108
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Impairment

Outcome Measures

Primary Outcomes (2)

• Cmax

  Maximum plasma concentration

  4 days

• AUC0-t and AUC0-inf

  Area under of the curve (AUC0-t and AUC0-inf)

  4 days

Study Arms (4)

Normal Hepatic Function

EXPERIMENTAL

Subjects with normal hepatic function will receive a single 48 mg oral dose of Chiglitazar

Drug: Chiglitazar

Mild Hepatic Impairment

EXPERIMENTAL

Subjects with mild hepatic impairment will receive a single 48 mg oral dose of Chiglitazar

Drug: Chiglitazar

Moderate Hepatic Impairment

EXPERIMENTAL

Subjects with moderate hepatic impairment will receive a single 48 mg oral dose of Chiglitazar

Drug: Chiglitazar

Severe Hepatic Impairment

EXPERIMENTAL

Subjects with severe hepatic impairment will receive a single 48 mg oral dose of Chiglitazar

Drug: Chiglitazar

Interventions

Chiglitazar DRUG

Oral single dose 48 mg

Mild Hepatic Impairment; Moderate Hepatic Impairment; Normal Hepatic Function; Severe Hepatic Impairment

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily sign informed consent, able to comply with the requirements of the study.
• Male or female, between 18 and 79 years of age.
• ≤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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chipscreen Biosciences, Ltd.: lead

Study Sites (1)

the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

MeSH Terms

Interventions

chiglitazar

Study Officials

• LiYan Miao

  First Affiliated Hospital of Suzhou Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 25, 2022
• Study Start: December 3, 2022
• Primary Completion: August 23, 2023
• Study Completion: August 23, 2023
• Last Updated: May 28, 2024

Record last verified: 2024-05

Locations

CN (1)