Pharmacokinetics of Omadacycline in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Pharmacokinetics of Omadacycline in Patients With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04460586
• Other study ID #: HS-20-00513
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 31, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Paul Beringer	Paratek Pharmaceuticals Inc

Country where clinical trial is conducted

United States, 

Outcome

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