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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Bacterial Infections

Intervention / Treatment
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* Drug: Omadacycline Injection [Nuzyra]
* Drug: Omadacycline Oral Tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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) |