drugset / Trial / NCT02082327

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

NCT02082327

Phase 1 Completed 31 enrolled Amicus Therapeutics
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2014-03
Primary completion
2014-06
Completion
2014-06

Drugs

EvaluationDrugModalityDoseRoute
Subject migalastat Other / unclassified 0.3 mg/kg Intravenous
Subject migalastat Other / unclassified 1 mg/kg Intravenous
Subject migalastat Other / unclassified 10 mg/kg Intravenous
Subject migalastat Other / unclassified 150 mg Intravenous

Indications