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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2023

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)

Arms, Groups and Cohorts

  • Experimental: Cohort 1 (adolescents)
    • 12 to < 18 years of age
  • Experimental: Cohort 2 (children)
    • 8 to < 12 years of age

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • Time Frame: Pre-dose, and 0.5, 1, 2, 8, and 24 hours post-dose
    • Plasma concentrations of omadacycline for PK analysis from Day 1 to Day 2
  • 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
    • Time Frame: Pre-dose, and 1, 2, 3, 8, and 24 hours post-dose
    • Plasma concentrations of omadacycline for PK analysis from Day 1 to Day 2

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 8 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Paratek Pharmaceuticals Inc
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Courtney Kirsch, 4847514925, courtney.kirsch@paratekpharma.com

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