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Completed

NCT Number: NCT02444234

Pharmacokinetics of Tedizolid Phosphate in Cystic Fibrosis

The proposed study is designed to characterize the pharmacokinetics of intravenous and oral tedizolid 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

Recent epidemiological studies have demonstrated that the presence of methicillin-resistant Staphylococcus aureus (MRSA) in the airways of patients with CF is associated with more rapid lung function decline and a higher mortality. Tedizolid is a new antibiotic with potent activity against MRSA. Tedizolid is currently FDA approved for treatment of skin soft tissue infections with MRSA. The proposed study is designed to characterize the pharmacokinetics of intravenous and oral tedizolid 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 > 17 years
  • Able to spontaneously expectorate sputum

Exclusion criteria

  • Any clinically significant laboratory abnormalities
  • Presence of an ongoing acute pulmonary exacerbation
  • Pregnancy
  • Serious past allergy to linezolid or tedizolid
  • No alcohol, nicotine, or caffeine-containing products during the study period

Treatment and study plan

Tedizolid PO

Drug

Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a 1 week washout.

Tedizolid IV

Drug

Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a 1 week washout.

Primary outcomes

  1. Peak Plasma Concentration (Cmax)

    Time frame: 2 days

    Cmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose

  2. Area Under the Plasma Concentration Versus Time Curve (AUC)

    Time frame: 2 days

    Area under the curve was calculated using samples collected at baseline (0 h) , 0.5, 1, 2, 3, 4, 8, 24, and 48 hours post-dose and using the equation AUC=Dose*F/CL

  3. Time to Peak Plasma Concentration (Tmax)

    Time frame: 2 days

    Tmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose

  4. Peak Sputum Concentration

    Time frame: 2 days

    Peak sputum concentration was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose.

  5. Area Under the Sputum Concentration Versus Time Curve (AUC)

    Time frame: 2 days

    AUC was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose

  6. Time to Peak Sputum Concentration (Tmax)

    Time frame: 2 days

    Tmax was calculated using data collected at 0, 0.5, 1, 2, 3, 4, 8, 24, 48 hours post-dose. Tmax was derived from pooled sputum data due to sparse samples and therefore do not have standard deviations.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Steady-State Pharmacokinetics of Tedizolid in Plasma and Sputum of Patients With Cystic Fibrosis

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 14, 2015
Registry last updated
Jun 2, 2020

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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