1.An open-label study to determine the pharmacokinetics and safety of migalastat HCl in subjects with impaired renal function and healthy subjects with normal renal function.
Johnson FK1, Mudd PN Jr2, DiMino T2, Vosk J1, Sitaraman S1, Boudes P1, France N2, Barlow C1. Clin Pharmacol Drug Dev. 2015 Jul;4(4):256-261. doi: 10.1002/cpdd.149. Epub 2014 Dec 22.
OBJECTIVES: Renal function may progressively decline in patients with Fabry disease. This study assessed pharmacokinetics, safety, and tolerability of a single oral dose of migalastat HCl 150 mg in subjects with normal or mildly, moderately, or severely impaired renal function.
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