NCT05893849

Pharmacokinetics of Clinical Probes and Characteristics of Endogenous Biomarker in Chinese Older Adults

A Single Center, Open Label Study of Pharmacokinetics of Clinical Probes and Characteristics of Endogenous Biomarker for Drug-metabolizing Enzymes and Transporters in Chinese Older Adults

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 624 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study aims to reveal the pharmacokinetics of clinical probes and characteristics of endogenous biomarkers for drug-metabolizing enzymes and transporters in Chinese older adults and old older adults, to analyze their correlation with frailty, and to explore the exosome characteristics in this population.

Detailed description

This study is a non-intervention observational study in Chinese older adults and will not interfere with the routine medical treatment. 6-10 mL whole blood and 20 mL urine samples (only applicable for patients taking meropenem and metformin) will be collected from eligible subjects according to medical routine blood collection time. Concentration of clinical probes and respective metabolites (when required), endogenous biomarkers, genotype information of drug-metabolizing enzymes and transporters, and the exosome characteristics will be quantified or measured.

Conditions

• Aging

Interventions

Type	Name	Description
DRUG	Clinical probes	Inpatients taking one or more clinical probes of CYP2C19 (omeprazole, rabeprazole, pantoprazole), CYP2D6 (metoprolol, carvedilol), CYP3A4 (rivaroxaban, finasteride, amlodipine, simvastatin), OAT (meropenem), OATP1B1 (atorvastatin, rosuvastatin) and OCT (metformin) will be included in the study.

Timeline

• Start date: 2023-03-28
• Primary completion: 2024-03-01
• Completion: 2024-04-01
• First posted: 2023-06-08
• Last updated: 2023-06-08

Locations

1 site across 1 country: China