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A Phase 1 Study To Evaluate the Safety of Migalastat Hydrochloride Given Intravenously to Healthy Volunteers

Amicus TherapeuticsCompletedPhase 1Started Mar 1, 201431 enrolledNetherlandsNCT02082327

Abstract

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of IV migalastat HCl alone and to determine absolute bioavailability for oral migalastat HCl as compared to IV administered migalastat HCl in healthy volunteers. The data from this study will help us understand how migalastat works in the body and will help us determine what would be an effective dose in future studies with migalastat hydrochloride.

Topics & conditions

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LSD

Keywords

Fabry DiseaseFabryLysosomal storage disordersAmicusmigalastat HClmigalastatAT1001Fabry Disease

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