Pharmacokinetics of Omadacycline in Cystic Fibrosis

Pharmacokinetics of Omadacycline in Patients With Cystic Fibrosis

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

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.

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