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Clinical Trial, Phase I
Journal Article
Pharmacokinetics of sugammadex in subjects with moderate and severe renal impairment .
AIMS: Sugammadex rapidly reverses moderate and deep rocuronium- or vecuronium-induced neuromuscular blockade at doses of 4 mg/kg and 2 mg/kg, respectively. Sugammadex is renally eliminated. This study evaluated the pharmacokinetics of sugammadex in subjects with renal impairment versus those with normal renal function.
METHODS: This open-label, two-part, phase 1 study included adults with moderate (creatinine clearance (CL<sub>cr</sub>) 30 - < 50 mL/min) and severe (CL<sub>cr</sub> < 30 mL/min) renal impairment and healthy controls (CL<sub>cr</sub> ≥ 80 mL/min). A single intravenous (IV) bolus injection of sugammadex 4 mg/kg was administered into a peripheral vein over 10 seconds directly by straight needle in part 1 (n = 24; 8/group), and via an IV catheter followed by a saline flush in part 2 (n = 18; 6/group). Plasma concentrations of sugammadex were collected after drug administration. Due to dosing issues in part 1, pharmacokinetic parameters were determined for part 2 only. Safety was assessed throughout the study.
RESULTS: Pharmacokinetic data were obtained from 18 subjects. Mean sugammadex exposure (AUC<sub>0-∞</sub>) in subjects with moderate and severe renal impairment was 2.42- and 5.42-times, respectively, that of healthy controls. Clearance decreased and apparent terminal half-life was prolonged with increasing renal dysfunction. Similar C<sub>max</sub> values were observed in subjects with renal impairment and healthy controls. There were no serious adverse events.
CONCLUSIONS: Sugammadex exposure is increased in subjects with moderate and severe renal insufficiency due to progressively decreased clearance as a function of worsening renal function. Sugammadex 4 mg/kg was well tolerated in subjects with renal impairment, with a safety profile similar to that of healthy subjects. These results indicate that dose adjustment of sugammadex is not required in patients with moderate renal impairment; however, current safety experience is insufficient to support the use of sugammadex in patients with CL<sub>cr</sub> < 30 mL/min. .
METHODS: This open-label, two-part, phase 1 study included adults with moderate (creatinine clearance (CL<sub>cr</sub>) 30 - < 50 mL/min) and severe (CL<sub>cr</sub> < 30 mL/min) renal impairment and healthy controls (CL<sub>cr</sub> ≥ 80 mL/min). A single intravenous (IV) bolus injection of sugammadex 4 mg/kg was administered into a peripheral vein over 10 seconds directly by straight needle in part 1 (n = 24; 8/group), and via an IV catheter followed by a saline flush in part 2 (n = 18; 6/group). Plasma concentrations of sugammadex were collected after drug administration. Due to dosing issues in part 1, pharmacokinetic parameters were determined for part 2 only. Safety was assessed throughout the study.
RESULTS: Pharmacokinetic data were obtained from 18 subjects. Mean sugammadex exposure (AUC<sub>0-∞</sub>) in subjects with moderate and severe renal impairment was 2.42- and 5.42-times, respectively, that of healthy controls. Clearance decreased and apparent terminal half-life was prolonged with increasing renal dysfunction. Similar C<sub>max</sub> values were observed in subjects with renal impairment and healthy controls. There were no serious adverse events.
CONCLUSIONS: Sugammadex exposure is increased in subjects with moderate and severe renal insufficiency due to progressively decreased clearance as a function of worsening renal function. Sugammadex 4 mg/kg was well tolerated in subjects with renal impairment, with a safety profile similar to that of healthy subjects. These results indicate that dose adjustment of sugammadex is not required in patients with moderate renal impairment; however, current safety experience is insufficient to support the use of sugammadex in patients with CL<sub>cr</sub> < 30 mL/min. .
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