Pharmacokinetics of Omadacycline in Cystic Fibrosis

Study Overview
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Brief Summary
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The purpose of this study is to characterize the pharmacokinetics of intravenous and oral omadacycline in patients with cystic fibrosis.

Detailed Description
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Omadacycline exhibits excellent activity against bacteria including methicillin-resistant Staphylococcus aureus (MRSA), Burkholderia cepacia, and Nontuberculous mycobacteria (NTM) that are a potential source of lung infection in CF patients. As omadacycline demonstrates antimicrobial activity against a number of pathogens in CF, the investigators hope to learn the optimal dose of omadacycline necessary to treat lung infections in patients with CF in the future. The study hypothesis is that omadacycline will exhibit good oral bioavailability in patients with CF.

Official Title
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Pharmacokinetics of Omadacycline in Patients With Cystic Fibrosis

Conditions
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Cystic Fibrosis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of CF based on positive sweat chloride or known CF mutation Age >=18 years Exclusion Criteria: Presence of an ongoing acute pulmonary exacerbation defined based on clinical signs & symptoms and an acute decline in relative FEV1 of 10% or greater. Pregnancy or breastfeeding Serious past allergy to a tetracycline antibiotic No alcohol, nicotine, or caffeine-containing products during the study period Hemoglobin < 8 g/dL

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Interventional Model Description: A single group of patients with CF will receive a single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of 300 mg PO.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omadacycline IV followed by PO<br>Omadacycline 100mg IV, Omadacycline 300 mg tablet | Drug: Omadacycline Injection [Nuzyra]<br>* Participants will receive single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of single dose omadacycline 300 mg PO.<br>Drug: Omadacycline Oral Tablet [Nuzyra]<br>* Participants will receive single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of single dose omadacycline 300 mg PO.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | To assess the maximum concentration of omadacycline after single dose of oral and intravenous administration. | 3 Days | 
| Tmax | To assess the time to maximum concentration of omadacycline after single dose of oral and intravenous administration. | 3 days | 
| AUC | To assess the area under the plasma concentration time curve of omadacycline after single dose of oral and intravenous administration. | 3 days | 
| Absolute Bioavailability | To determine the absolute bioavailability of omadacycline following single dose of IV and PO administration. | 6 days |