Renal 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 renal impairment compared to subjects with normal renal 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. * 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.
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