Pharmacokinetics of Chiglitazar in Subjects With Renal Impairment and Normal Renal Function
- Registration Number
- NCT05515458
- Lead Sponsor
- Chipscreen Biosciences, Ltd.
- 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 renal impairment compared to subjects with normal renal function.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normal Renal Function Chiglitazar Subjects with normal renal function will receive a single 48 mg oral dose of Chiglitazar Severe Renal Impairment Chiglitazar Subjects with severe renal impairment will receive a single 48 mg oral dose of Chiglitazar
- Primary Outcome Measures
Name Time Method Cmax 4 days Maximum plasma concentration
AUC0-t and AUC0-inf 4 days Area under of the curve (AUC0-t and AUC0-inf)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
the First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China