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

• Status: Not yet recruiting
• Trial end date: 2023-12-30
• Target enrollment: 0
• Participant gender: All

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 renal impairment compared to subjects with normal renal function.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Chipscreen Biosciences, Ltd.

Criteria

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.