Radboud umc

Radboud University Medical Centre specializes in patient care, scientific research, teaching and training. Its Department of Pharmacy will perform PK analyses and PK/PD modeling for this project.

Work Package 6

PHARMACOKINETICS (PK)

OBJECTIVES
To determine sutezolid PK in plasma using sparse sampling, and to analyze the PK/PD relationship

DESCRIPTION OF WORK TO BE CONDUCTED
RUMC will assist in determining the optimal timing for collection of samples for sutezolid PK based on data from the SUDOCU study. Plasma samples will be shipped from clinical sites to RUMC, who will use previously validated methods to analyze concentrations of sutezolid and U-603. They will also use a previously validated PK model to predict exposures based these sparse samples. An initial sample of the first 10 subjects will be analyzed early in the study. A second sample of all remaining subjects will be examined later in the study. Findings will be examined in relation to study outcomes (efficacy and safety).