NCT01380743

Drug-drug Interaction Study

An Open-Label, Multi-Center, International Study to Investigate Drug-Drug Interactions Between AT2220 and Alglucosidase Alfa in Patients With Pompe Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Amicus Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates drug-drug interactions between AT2220 (duvoglustat) and recombinant human alpha-glucosidase (rhGAA, also known as alglucosidase alfa) in participants with Pompe Disease.

Detailed description

This was a multi-center, international, open-label, two-period, fixed-sequence crossover study to evaluate the safety and pharmacokinetic effect of single ascending doses of duvoglustat on rhGAA administered 1 hour before initiation of a single rhGAA infusion. During Period 1, participants received a single intravenous infusion of rhGAA. During Period 2, each participant received a single oral dose of duvoglustat 1 hour prior to initiation of a single rhGAA infusion.

Conditions

• Pompe Disease

Interventions

Type	Name	Description
DRUG	duvoglustat	Single oral dose
DRUG	rhGAA	Single intravenous infusion

Timeline

• Start date: 2011-10-31
• Primary completion: 2013-01-04
• Completion: 2013-01-04
• First posted: 2011-06-27
• Last updated: 2025-06-26
• Results posted: 2018-08-17

Locations

15 sites across 4 countries: United States, Canada, France, United Kingdom