Pharmacokinetics of Omadacycline in Cystic Fibrosis

Phase 4

Completed

• Conditions: Cystic Fibrosis
• Interventions: Drug: Omadacycline Injection [Nuzyra]; Drug: Omadacycline Oral Tablet [Nuzyra]

• Registration Number: NCT04460586
• Lead Sponsor: Paul Beringer

Brief 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.

Study Timeline

• Study First Submitted: 2020-07-01
• Study First Submitted QC: 2020-07-01
• Study First Posted: 2020-07-07
• Study Start: 2021-07-01
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Omadacycline IV followed by PO	Omadacycline Oral Tablet [Nuzyra]	Omadacycline 100mg IV, Omadacycline 300 mg tablet
Omadacycline IV followed by PO	Omadacycline Injection [Nuzyra]	Omadacycline 100mg IV, Omadacycline 300 mg tablet

Primary Outcome Measures

Name	Time	Method
Cmax	3 Days	To assess the maximum concentration of omadacycline after single dose of oral and intravenous administration.
Absolute Bioavailability	6 days	To determine the absolute bioavailability of omadacycline following single dose of IV and PO administration.
Tmax	3 days	To assess the time to maximum concentration of omadacycline after single dose of oral and intravenous administration.
AUC	3 days	To assess the area under the plasma concentration time curve of omadacycline after single dose of oral and intravenous administration.

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States