Pharmacokinetics of Omadacycline in Cystic Fibrosis

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Paul Beringer
• Collaborator: Paratek Pharmaceuticals Inc

Criteria

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