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

Study Overview
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Brief Summary
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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 renal impairment compared to subjects with normal renal function.

Official Title
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Study to Evaluate the Pharmacokinetics of Chiglitazar in Subjects With Renal Impairment and Normal Renal Function

Conditions
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Renal Impairment

Intervention / Treatment
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* Drug: Chiglitazar


Participation Criteria
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Eligibility Criteria
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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. the absolute eGFR must meet standard in renal function classification. 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, and serum potassium ≥3.5 mmol/L and ≤5.5 mmol/L. 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. suffer from uncontrolled serious diseases of heart failure/hypertension, respiratory, liver, 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 within 5 years before screening., 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. 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 have received blood products. Acute hepatitis, chronic liver disease, or any one of ALT, AST, and total bilirubin is greater than 2 times the upper limit of normal. HBsAg, HCV antibody, HIV antibody, or TP antibody antibody positive. Female subjects who are breastfeeding or positive test of serum pregnancy. Other circumstances assessed by the investigator are not suitable for participating in this trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal Renal Function<br>Subjects with normal renal function will receive a single 48 mg oral dose of Chiglitazar | Drug: Chiglitazar<br>* Oral single dose 48 mg<br>|
| Experimental: Severe Renal Impairment<br>Subjects with severe renal impairment will receive a single 48 mg oral dose of Chiglitazar | Drug: Chiglitazar<br>* Oral single dose 48 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum plasma concentration | 4 days | 
| AUC0-t and AUC0-inf | Area under of the curve (AUC0-t and AUC0-inf) | 4 days |