ClinicalTrials.Veeva

Menu

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

C

Chipscreen Biosciences

Status and phase

Completed
Phase 1

Conditions

Hepatic Impairment

Treatments

Drug: Chiglitazar

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

18 to 79 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 4 patient groups

Normal Hepatic Function
Experimental group
Description:
Subjects with normal hepatic function will receive a single 48 mg oral dose of Chiglitazar
Treatment:
Drug: Chiglitazar
Mild Hepatic Impairment
Experimental group
Description:
Subjects with mild hepatic impairment will receive a single 48 mg oral dose of Chiglitazar
Treatment:
Drug: Chiglitazar
Moderate Hepatic Impairment
Experimental group
Description:
Subjects with moderate hepatic impairment will receive a single 48 mg oral dose of Chiglitazar
Treatment:
Drug: Chiglitazar
Severe Hepatic Impairment
Experimental group
Description:
Subjects with severe hepatic impairment will receive a single 48 mg oral dose of Chiglitazar
Treatment:
Drug: Chiglitazar

Trial contacts and locations

1

Loading...

Central trial contact

Yu Chen; LiYan Miao

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems