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A phase 1 study of intravenously administered TR-701 FA in subjects with advanced renal impairment
Critical Care volume 17, Article number: P25 (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 .
Baseline eGFR ranged from 7 to 28 ml/minute/1.73 m2 (including three subjects with eGFR <15 ml/minute/1.73 m2). The pharmacokinetics of TR-700 was essentially unchanged in subjects with advanced renal impairment relative to a matched control group. Approximately 8% lower AUC and nearly identical Cmax values were observed in renal impaired subjects relative to matched controls, and other pharmacokinetic parameters were also similar between groups. See Table 1.
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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Flanagan, S., Morris, D., Boyea, T. et al. A phase 1 study of intravenously administered TR-701 FA in subjects with advanced renal impairment. Crit Care 17 (Suppl 3), P25 (2013). https://doi.org/10.1186/cc12641
- Pharmacokinetic Parameter
- Dose Adjustment
- Matched Control
- Normal Renal Function
- Matched Control Group