Pharmacokinetics of Omadacycline in Cystic Fibrosis

February 20, 2024 updated by: Paul Beringer

Pharmacokinetics of Omadacycline in Patients With Cystic Fibrosis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Paul M. Beringer, PharmD
  • Phone Number: 323-442-1402
  • Email: beringer@usc.edu

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90089
        • University of Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Omadacycline IV followed by PO
Omadacycline 100mg IV, Omadacycline 300 mg tablet
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paul Beringer

Collaborators

Paratek Pharmaceuticals Inc

Investigators

  • Study Director: Adupa P Rao, M.D., Keck Medicine of USC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

July 1, 2020

First Submitted That Met QC Criteria

July 1, 2020

First Posted (Actual)

July 7, 2020

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-20-00513

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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