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

Sponsor
Paratek Pharmaceuticals Inc (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05217537
Collaborator
(none)
40
Enrollment
5
Locations
2
Arms
18.9
Anticipated Duration (Months)
8
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Omadacycline Injection [Nuzyra]
  • Drug: Omadacycline Oral Tablet
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
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
Actual Study Start Date :
Apr 6, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 [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

    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 [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 Outcome Measures

    1. Adverse events and serious adverse events [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

    2. Clinical laboratory tests [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

    3. Vital signs [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

    4. Physical examination [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site 109 Little Rock Arkansas United States 72202
    2 Site 107 Orange California United States 92868
    3 Site 105 Chicago Illinois United States 60611
    4 Site 106 Cleveland Ohio United States 60611
    5 Site 108 Houston Texas United States 77030

    Sponsors and Collaborators

    • Paratek Pharmaceuticals Inc

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Paratek Pharmaceuticals Inc
    ClinicalTrials.gov Identifier:
    NCT05217537
    Other Study ID Numbers:
    • PTK0796-PEDPK-20110
    First Posted:
    Feb 1, 2022
    Last Update Posted:
    Jun 27, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Bacterial Infections

    Study Results

    No Results Posted as of Jun 27, 2022