Hepatic Impairment
Conditions
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.
Interventions
DRUGChiglitazar
Oral single dose 48 mg
Sponsors
Chipscreen Biosciences, Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 4 days | Maximum plasma concentration |
| AUC0-t and AUC0-inf | 4 days | Area under of the curve (AUC0-t and AUC0-inf) |
Countries
China
Outcome results
None listed