Pharmacokinetics of Tedizolid Phosphate in Cystic Fibrosis

University of Southern California11 enrolled

Overview

The proposed study is designed to characterize the pharmacokinetics of intravenous and oral tedizolid in patients with Cystic Fibrosis.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis

Interventions

Tedizolid PODRUG

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 IVDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Southern California

Los Angeles, California, United States

Outcomes

Primary Outcomes

Peak Plasma Concentration (Cmax)

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

Time frame: 2 days

Area Under the Plasma Concentration Versus Time Curve (AUC)

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

Time frame: 2 days

Time to Peak Plasma Concentration (Tmax)

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

Time frame: 2 days

Peak Sputum Concentration

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

Time frame: 2 days

Area Under the Sputum Concentration Versus Time Curve (AUC)

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

Time frame: 2 days

Time to Peak Sputum Concentration (Tmax)

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.

Time frame: 2 days

Data from ClinicalTrials.gov

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