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Pharmacokinetics of Chiglitazar in Subjects With Renal Impairment and Normal Renal Function | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT05515458•Chipscreen Biosciences, Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 79 years

Sex

ALL

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.
+6 more criteria

Locations (1)

the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Key Dates

Start Date

November 20, 2022

Primary Completion Date

July 19, 2023

Completion Date

July 19, 2023

Last Updated

May 28, 2024

Enrollment

ACTUAL participants

Conditions

Renal Impairment

Interventions

Chiglitazar

DRUG

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Renal Impairment

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 28, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)

A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment

A Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems

A Study of RG002C0106 Injection in Adult Participants With Normal Renal Function and Mild-to-Moderate Renal Impairment

A Study to Investigate the Pharmacokinetics, Safety and Tolerability of AZD5462 in Participants With Renal Impairment

DESIR. Evaluation of the Pre-therapeutic Activity of Dihydropyrimidine dEShydrogenase (DPD) in Patients With Cancer and/or Renal Failure