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

NCT05217537 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2026-03-09

Study results available
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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

Interventions

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)

Sponsors & Collaborators

  • Paratek Pharmaceuticals Inc

    lead INDUSTRY

Principal Investigators

  • Amy Manley · Paratek Pharmaceuticals Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-06
Primary Completion
2025-02-27
Completion
2025-02-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05217537 on ClinicalTrials.gov