At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 20 enrolled
Drug / intervention
Migalastat HCl +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label Phase 2A Study to Investigate Drug-Drug Interactions Between AT1001 (Migalastat Hydrochloride) and Agalsidase in Subjects With Fabry Disease
In Brief
A Phase 2 clinical trial evaluating Migalastat HCl, Agalsidase Beta, and 1 other intervention for Fabry Disease. Completed, enrolled 20 participants across 10 sites in 5 countries.
Detailed Summary
The objective was to determine the effects of a single dose of migalastat hydrochloride (HCl) (migalastat) 150 and 450 milligrams (mg) on the safety and plasma pharmacokinetics (PK) of agalsidase and the effects of agalsidase on the safety and PK of migalastat 150 mg.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFabry Disease
CountriesAustralia, Belgium, Canada, Netherlands, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2010
Enrollment StartFeb 2011
Primary CompletionOct 2012
TodayJul 2026
First PostedSep 9, 2010
Enrollment StartFeb 2, 2011
Primary CompletionOct 9, 2012
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 15.8 years ago
Interventions
Migalastat HCldrug
Oral capsules, single dose
Agalsidase Betabiological
IV infusion, single dose
Agalsidase Alfabiological
IV infusion, single dose