Drug Drug interaction Trial between AT1001 & Agalsidase Version 4
Research type
Research Study
Full title
AN OPEN-LABEL PHASE 2A STUDY TO INVESTIGATE DRUG-DRUG INTERACTIONS BETWEEN AT1001 (MIGALASTAT HYDROCHLORIDE) AND AGALSIDASE IN SUBJECTS WITH FABRY DISEASE
IRAS ID
108337
Contact name
Derralynn Hughes
Eudract number
2010-022709-16
Clinicaltrials.gov Identifier
Research summary
Fabry disease is an inherited change of the genetic material (DNA), which results in lower than normal levels of an enzyme called alpha-galactosidase A (alpha-Gal A). AT1001 (Migalastat hydrocholride) is an investigational therapeutic agent. The purpose of the trial is to find out if AT1001 can help people with Fabry disease and if it is safe. This is a phase 2a open label trial and will provide drug-drug interaction information after co-administration of AT1001 and standard of care enzyme replacement therapy (ERT) agalsidase. The trial is in two stages. Stage 1: During the first stage the trial will evaluate the effect of a 150mg dose of AT1001 on the pharmokinetics and safety of agalsidase and the effect of agalsidase on the pharmacokinetics and safety of the 150mg dose of AT1001. Stage 2: During stage two the trial will evaluate the effect of 450mg AT1001 on the pharmacokinetics and safety of agalsidase. But during stage two the trial will not evaluate the effect of agalsidase on the pharmacokinetics and safety of a 450 mg dose of AT1001. This trial is for the inclusion of male subjects between 18 and 65 years of age who have been diagnosed with Fabry disease and have been receiving a stable dose of agalsidase alpha or beta for at least one month before study entry and meet all other inclusion and none of the exclusion criteria.
REC name
London - City & East Research Ethics Committee
REC reference
12/LO/1017
Date of REC Opinion
23 Aug 2012
REC opinion
Further Information Favourable Opinion