Pharmacokinetics of Omadacycline in Cystic Fibrosis

Paul Beringer

Status and phase: Completed; Phase 4

Conditions: Cystic Fibrosis

Treatments: Drug: Omadacycline Oral Tablet [Nuzyra]; Drug: Omadacycline Injection [Nuzyra]

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04460586

HS-20-00513

Details and patient eligibility

About

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

Full description

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Omadacycline IV followed by PO

Experimental group

Description:

Omadacycline 100mg IV, Omadacycline 300 mg tablet

Treatment:

Drug: Omadacycline Oral Tablet [Nuzyra]

Drug: Omadacycline Injection [Nuzyra]