A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of Migalastat Hydrochloride Given Intravenously to Healthy Volunteers With an Open-Label, Randomized, Two-Way Crossover Arm

Trial Profile

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of Migalastat Hydrochloride Given Intravenously to Healthy Volunteers With an Open-Label, Randomized, Two-Way Crossover Arm

Completed
Phase of Trial: Phase I

Latest Information Update: 28 Jul 2014

At a glance

  • Drugs Migalastat (Primary) ; Migalastat (Primary)
  • Indications Fabry's disease
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Amicus Therapeutics
  • Most Recent Events

    • 17 Jun 2014 Status changed from recruiting to completed as reported by ClinicalTrials.gov record.
    • 30 Apr 2014 Planned End Date changed from 1 May 2014 to 1 Jun 2014 as reported by ClinicalTrials.gov record.
    • 30 Apr 2014 Planned number of patients changed from 21 to 31 as reported by ClinicalTrials.gov record.
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