Pharmacokinetics of Chiglitazar in Subjects With Hepatic Impairment and Normal Hepatic Function
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Cmax [4 days]
Maximum plasma concentration
- AUC0-t and AUC0-inf [4 days]
Area under of the curve (AUC0-t and AUC0-inf)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Voluntarily sign informed consent, able to comply with the requirements of the study.
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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:
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Allergic constitution, or allergic to PPAR agonist drugs or any component of Chiglitazar tablets.
-
received PPAR agonist drugs within 2 weeks before screening.
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Those who have been vaccinated within 4 weeks before screening, or who plan to be vaccinated during the trial.
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positive test for COVID-19, TP antibody and RPR, or HIV antibody.
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suffer from uncontrolled serious diseases of cardiovascular, respiratory, gastrointestinal, endocrine, blood, mental/nervous systems within 1 year before screening.
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have previously undergone surgery that may affect the absorption, distribution, metabolism, and excretion of drugs; anticipate surgery or hospitalization during the trial.
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Drug abusers, or positive test for drugs of abuse.
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Smoking more than 5 cigarettes per day on average within 3 months before screening.
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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.
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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.
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participated in clinical trials of any drug or medical device within 3 months before screening.
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donated blood (or blood loss) ≥400 mL within 3 months before screening, or received whole blood or red blood cell suspension.
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Female subjects who are breastfeeding or positive test of serum pregnancy.
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eGFR<60 mL/min/1.73m2.
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Chipscreen Biosciences, Ltd.
Investigators
- Principal Investigator: LiYan Miao, First Affiliated Hospital of Suzhou Medical College
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CGZ108