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Completed

NCT Number: NCT04460586

Pharmacokinetics of Omadacycline in Cystic Fibrosis

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

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Southern California

Los Angeles, California, 90089, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omadacycline Injection [Nuzyra]

Drug

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]

Drug

Participants will receive single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of single dose omadacycline 300 mg PO.

Primary outcomes

  1. Cmax

    Time frame: 3 Days

    To assess the maximum concentration of omadacycline after single dose of oral and intravenous administration.

  2. Tmax

    Time frame: 3 days

    To assess the time to maximum concentration of omadacycline after single dose of oral and intravenous administration.

  3. AUC

    Time frame: 3 days

    To assess the area under the plasma concentration time curve extrapolated to infinity of omadacycline after single dose of oral and intravenous administration.

  4. Absolute Bioavailability

    Time frame: 6 days

    To determine the absolute bioavailability (%) of omadacycline following single dose of IV and PO administration.

Sponsors and collaborators

Lead sponsor

Paul Beringer

Other

Collaborators

  • Paratek Pharmaceuticals Inc

Registry information

Official study title

Pharmacokinetics of Omadacycline in Patients With Cystic Fibrosis

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 7, 2020
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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