A phase 1 study of intravenously administered TR-701 FA in subjects with advanced renal impairment
© Flanagan et al; licensee BioMed Central Ltd. 2013
Published: 19 June 2013
The objective of the study was to characterize the safety of tedizolid phosphate (TR-701 FA) and the pharmacokinetics of tedizolid (TR-700), its microbiologically active moiety, in subjects with advanced renal impairment (eGFR <30 ml/minute/1.73 m2, not on dialysis) compared with matched subjects with normal renal function (eGFR ≥80.0 ml/minute/1.73 m2).
Eight subjects with advanced renal impairment and eight matched controls (by age, gender, and body mass index) received a single intravenous infusion of 200 mg TR-701 FA. Serial plasma PK samples were collected from pre-dose through 72 hours post-dose. Plasma samples were analyzed for TR-700 and the following pharmacokinetic parameters were calculated: Cmax, tmax, AUC0−∞, AUC0−t λz, CLsys, and plasma .
Pharmacokinetic parameters of tedizolid in control and renal impaired subjects
Geometric mean (GM)
Advanced renal impairment
The TR-700 plasma pharmacokinetic results from this study provide support that no dose adjustment is needed in subjects with advanced renal impairment.
Trial registration: NCT01452828.
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