NCT05584683

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

A Single Dose Study to Determine the Pharmacokinetic Profiles of Amoxicillin and Clavulanate in Pediatric Patients Receiving Either LP-001 or Augmentin ES-600 Orally

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Kaizen Bioscience Co. · Industry
• Sex: All
• Age: 3 Months – 24 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the pharmacokinetic profiles of LP-001, an amoxicillin and clavulanate formulation compared to the pharmacokinetic profiles of Augmentin ES-600 for use in pediatric patients with a bacterial infection.

Detailed 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 patients will each receive a single dose of LP-001 in a fed state while 15 pediatric patients will each receive a single dose of Augmentin ES-600 in a fed state. 3-4 blood draws per patient will be attempted up to 8 hours post dose.

Conditions

• Pediatric
• Bacterial Infections

Interventions

Type	Name	Description
DRUG	Amoxicillin potassium clavulanate	LP-001 will be reconstituted and administered as a single dose
DRUG	Amoxicillin potassium clavulanate (Augmentin ES-600)	Augmentin ES-600 will be reconstituted and administered as a single dose

Timeline

• Start date: 2023-08-09
• Primary completion: 2024-12-16
• Completion: 2024-12-16
• First posted: 2022-10-18
• Last updated: 2025-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study