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

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.

Study Overview

• Status: Recruiting
• Conditions: Bacterial Infections
• Intervention / Treatment: Drug: Omadacycline Injection [Nuzyra]; Drug: Omadacycline Oral Tablet

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Amy Manley; Email: amy.manley@paratekpharma.com
• Study Contact Backup: Name: Courtney Kirsch; Phone Number: 4847514925; Email: courtney.kirsch@paratekpharma.com

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Recruiting
      • Site 109
      • Contact: Snowden
  • California
    • Long Beach, California, United States, 90806
      • Recruiting
      • Site 112
      • Contact: Deveikis
    • Orange, California, United States, 92868
      • Recruiting
      • Site 107
      • Contact: Arrieta
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Site 105
      • Contact: Mueller
  • North Carolina
    • Greenville, North Carolina, United States, 27858
      • Recruiting
      • Site 111
  • Ohio
    • Cleveland, Ohio, United States, 60611
      • Recruiting
      • Site 106
      • Contact: Desai
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Site 108
      • Contact: Heresi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female subjects, age 8 to < 18 (inclusive) who have written and signed parental/legal authorized representative (LAR) informed consent and pediatric assent.
• Currently hospitalized with a suspected or confirmed bacterial infection and receiving or planned to receive systemic antibiotic therapy other than omadacycline.
• Weight within the 5th and 95th percentile for age and sex.
• Subjects must not be pregnant or nursing at the time of enrollment, and must agree to use a highly effective birth control method during the study

Exclusion Criteria:

• Evidence of a medical condition that may pose a safety risk or impair study participation.
• Confirmed or suspected SARS-CoV-2 infection.
• Has a history of hypersensitivity or allergic reaction to any tetracycline antibiotic.
• Has received an investigational drug within the past 30 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 (adolescents); 12 to < 18 years of age	Drug: Omadacycline Injection [Nuzyra]; Single dose of 100 mg omadacycline IV in 100 mL of normal saline; Other Names: NUZYRA; Drug: Omadacycline Oral Tablet; Single dose of 300 mg omadacycline PO (2 x 150 mg tablets); Other Names: NUZYRA
Experimental: Cohort 2 (children); 8 to < 12 years of age	Drug: Omadacycline Injection [Nuzyra]; Single dose of 100 mg omadacycline IV in 100 mL of normal saline; Other Names: NUZYRA; Drug: Omadacycline Oral Tablet; Single dose of 300 mg omadacycline PO (2 x 150 mg tablets); Other Names: NUZYRA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterize the PK of a single IV dose of omadacycline in children and adolescents 8 to < 18 years of age with suspected or confirmed bacterial infections	Plasma concentrations of omadacycline for PK analysis from Day 1 to Day 2	Pre-dose, and 0.5, 1, 2, 8, and 24 hours post-dose
Characterize the PK of a single PO dose of omadacycline in children and adolescents 8 to < 18 years of age with suspected or confirmed bacterial infections	Plasma concentrations of omadacycline for PK analysis from Day 1 to Day 2	Pre-dose, and 1, 2, 3, 8, and 24 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events and serious adverse events	Incidence, severity, and type of adverse events and serious adverse events	From the time of signing the informed consent form up to study completion visit (up to 9 days)
Clinical laboratory tests	Number of participants with abnormal clinical laboratory tests	From the time of signing the informed consent form up to study completion visit (up to 9 days)
Vital signs	Number of participants with clinically significant changes from baseline in vital signs	From the time of signing the informed consent form up to study completion visit (up to 9 days)
Physical examination	Number of participants with clinically significant abnormal physical examination findings	From the time of signing the informed consent form up to study completion visit (up to 9 days)

Collaborators and Investigators

• Sponsor: Paratek Pharmaceuticals Inc
• Investigators: Study Director: Amy Manley, Paratek Pharmaceuticals Inc

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2022
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: December 15, 2021
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Bacterial Infections
• Other Study ID Numbers: PTK0796-PEDPK-20110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No