Pharmacokinetic evaluation of single-dose migalastat in non-fabry disease subjects with esrd receiving dialysis treatment, and use of modeling to select dose regimens in fabry disease subjects with esrd receiving dialysis treatment

HIGHLIGHTS

• What: This study investigated the pharmacokinetics (PK) dialyzability and tolerability of 123 mg migalastat in non-FD subjects with ESRD on stable hemodialysis/hemodiafiltration (EudraCT 2018-003684-57). The observed increased exposure in subjects with ESRD compared with the matched controls with NRF in this study is in line with results observed in a previous study (AT1001-015), where it was shown that migalastat plasma clearance decreased significantly in severe renal impairment, leading to significant prolongation of plasma terminal elimination half-life . The study was designed to observe the effect of dosing migalastat 24 hours before dialysis . . .
  

   

  

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