3 results
The objectives of this open-label study are to evaluate the efficacy (GL-3 clearance), pharmacokinetics (PK), and safety parameters (including immunogenicity) for 2 alternative dose regimens of Fabrazyme (0.5 mg/kg every 2 weeks [q2w] and 1.0 mg/kg…
The primary objectives of this study are: * To characterize the effects of 150 mg and 450 mg of AT1001 administered 2 hours before administration of agalsidase on the safety and plasma pharmacokinetics of agalsidase in subjects with Fabry Disease*…
Primary Objectives:Part 1- Estimate the relative bioavailability of the tablet formulation of TAK-931 in reference to the PIC formulation.Part 2- Assess the effect of a high-fat meal on the single dose PK of TAK-931 administered as the tablet…