A pilot study to develop a population pharmacokinetic (PopPK) model for vancomycin in underweight subjects with normal renal function

Hanyang University Seoul Hospital0 sites12 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

December 28, 2022

Last Updated

2 years ago

Study Type

Interventional Study

Sex

All

Sponsor

Hanyang University Seoul Hospital

•1\) Subjects aged between 19 and 65 (inclusive) at screening
•2\) Subjects who have a body mass index greater than 14 4 kg/m2 (inclusive) and less than 18\.5 kg/m2 (not inclusive)
•3\) If female, the subject should not be pregnant or breastfeeding, or the subject should have undergone sterilization operation.
•4\) Subjects who voluntarily decided to participate in the study and provided written consent to comply with the protocol
•5\) Clinically confirmed as eligible to participate in this study based on physical examination, clnical laboratory tests, medical history

•1\) Current or history of a clinically significant hepatic (severe hepatic impairment), renal (severe renal impairment), neurological, immune, respiratory, gastrointestinal, endocrine, hemato\-oncological, cardiovascular (heart failure, Torsades de pointes, etc.), urological, psychiatric disease
•2\) Subjects with any of the following conditions
•\- history of shock due to vancomycin
•\- history of hypersensitivity due to vancomycin, peptide antibiotics, or aminoglycoside antibiotics
•\- history of hearing disorder due to peptide antibiotics or aminoglycoside antibiotics
•\- history of vestibular organ or cochlear damage
•3\) Subjects with any of the following results at the time of screening
•\- serum AST (SGOT), ALT (SGPT), T.bil, ALP: \> ULN x 2\.0
•\- eGFR using CKD\-EPI equation: \< 90 mL/min
•4\) Subjects with systolic blood pressure \< 80 mmHg or \> 150 mmHg, or diastolic blood pressure \< 50 mmHg or \> 100 mmHg at a sitting position with more than 3 min of resting