Pharmacokinetics of Tedizolid Phosphate in Cystic Fibrosis

Steady-State Pharmacokinetics of Tedizolid in Plasma and Sputum of Patients With Cystic Fibrosis

The proposed study is designed to characterize the pharmacokinetics of intravenous and oral tedizolid in patients with Cystic Fibrosis.

Recent epidemiological studies have demonstrated that the presence of methicillin-resistant Staphylococcus aureus (MRSA) in the airways of patients with CF is associated with more rapid lung function decline and a higher mortality. Tedizolid is a new antibiotic with potent activity against MRSA. Tedizolid is currently FDA approved for treatment of skin soft tissue infections with MRSA. The proposed study is designed to characterize the pharmacokinetics of intravenous and oral tedizolid in patients with CF.

Inclusion Criteria:

• Diagnosis of CF based on positive sweat chloride or known CF mutation
• Age > 17 years
• Able to spontaneously expectorate sputum

Exclusion Criteria:

• Any clinically significant laboratory abnormalities
• Presence of an ongoing acute pulmonary exacerbation
• Pregnancy
• Serious past allergy to linezolid or tedizolid
• No alcohol, nicotine, or caffeine-containing products during the study period