NCT04460586

Pharmacokinetics of Omadacycline in Cystic Fibrosis

Pharmacokinetics of Omadacycline in Patients With Cystic Fibrosis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Paul Beringer · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	Omadacycline Injection [Nuzyra]	Participants will receive single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of single dose omadacycline 300 mg PO.
DRUG	Omadacycline Oral Tablet [Nuzyra]	Participants will receive single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of single dose omadacycline 300 mg PO.

Timeline

• Start date: 2021-07-01
• Primary completion: 2023-12-01
• Completion: 2023-12-31
• First posted: 2020-07-07
• Last updated: 2024-02-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study