A Pharmacokinetic Study of LP-001 in Children With a Bacterial Infection

Status Recruiting

Clinical Trial Summary

The purpose of this study is to determine the pharmacokinetic profiles of LP-001, an amoxicillin and clavulanate formulation, for use in pediatric patients with a bacterial infection.

Clinical Trial Description

This is a single site, open-label, single dose Phase 1 pharmacokinetic study of LP-001, an amoxicillin and clavulanate formulation, for use in pediatric patients between 3 and 24 months of age with a bacterial infection. 24 pediatric subjects will each receive a single dose of LP-001 in a fed state. 3 attempted blood draws per patient will be attempted up to 3 hours post dose. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05584683
Study type	Interventional
Source	Kaizen Bioscience Co.
Contact	Sonya Tang Girdwood, MD
Phone	1-800-344-2462
Email	sonya.tanggirdwood@cchmc.org
Status	Recruiting
Phase	Phase 1
Start date	August 9, 2023
Completion date	June 10, 2024

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