NCT05217537

Study to Evaluate the PK of IV and PO Omadacycline in Children and Adolescents With Suspected or Confirmed Bacterial Infections

A Phase 1, Open-Label, Multi-Center Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Intravenous and Oral Doses of Omadacycline in Pediatric Subjects With Suspected or Confirmed Bacterial Infections

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Paratek Pharmaceuticals Inc · Industry
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the pharmacokinetics of a single dose of intravenous or oral omadacycline in children and adolescents with suspected or confirmed bacterial infections.

Conditions

• Bacterial Infections

Interventions

Type	Name	Description
DRUG	Omadacycline Injection [Nuzyra]	Single dose of 100 mg omadacycline IV in 100 mL of normal saline
DRUG	Omadacycline Oral Tablet	Single dose of 300 mg omadacycline PO (2 x 150 mg tablets)

Timeline

• Start date: 2022-04-06
• Primary completion: 2025-02-27
• Completion: 2025-02-27
• First posted: 2022-02-01
• Last updated: 2026-03-09
• Results posted: 2026-03-09

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study