Pharmacokinetics of Omadacycline in Cystic Fibrosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2023-12-31

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.

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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.

Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Omadacycline IV followed by PO

Omadacycline 100mg IV, Omadacycline 300 mg tablet

Group Type EXPERIMENTAL

Omadacycline Injection [Nuzyra]

Intervention Type DRUG

Participants will receive single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of single dose omadacycline 300 mg PO.

Omadacycline Oral Tablet [Nuzyra]

Intervention Type DRUG

Participants will receive single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of single dose omadacycline 300 mg PO.

Interventions

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Omadacycline Injection [Nuzyra]

Participants will receive single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of single dose omadacycline 300 mg PO.

Intervention Type DRUG

Omadacycline Oral Tablet [Nuzyra]

Participants will receive single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of single dose omadacycline 300 mg PO.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No