NCT05515458CompletedPhase 1
Study to Evaluate the Pharmacokinetics of Chiglitazar in Subjects With Renal Impairment and Normal Renal Function
Chipscreen Biosciences, Ltd.1 site in 1 country24 target enrollmentStarted: November 20, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- AUC0-t and AUC0-inf
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
- •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-
- •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.
Arms & Interventions
Normal Renal Function
Experimental
Subjects with normal renal function will receive a single 48 mg oral dose of Chiglitazar
Intervention: Chiglitazar (Drug)
Severe Renal Impairment
Experimental
Subjects with severe renal impairment will receive a single 48 mg oral dose of Chiglitazar
Intervention: Chiglitazar (Drug)
Outcomes
Primary Outcomes
AUC0-t and AUC0-inf
Time Frame: 4 days
Area under of the curve (AUC0-t and AUC0-inf)
Cmax
Time Frame: 4 days
Maximum plasma concentration
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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