Pharmacokinetics of Tedizolid Phosphate in Cystic Fibrosis

• Status: Completed
• Trial end date: 2017-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Southern California
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Oxazolidinones; Tedizolid; Torezolid

Criteria

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