Drug-Drug Interaction Study Between AT1001 and Agalsidase in Subjects With Fabry Disease

Inclusion Criteria:

• Male diagnosed with Fabry disease and between 18 and 65 years of age, inclusive
• Body mass index between 18-35
• Subject initiated treatment with agalsidase at lease one month, having received at least two infusions, before the Screening Visit
• Subject's dose level, dosing regimen and form of agalsidase have been stable for at least one month before Screening Visit
• Subject has an estimated creatinine clearance greater than or equal to 50mL/min at Screening
• Subject agrees to use medically-accepted methods of contraception during the study and for 30 days after study completion
• Subject is willing and able to provide written informed consent

Exclusion Criteria:

• Subject has had a documented transient ischemic attack, ischemic stroke, unstable angina, or myocardial infarction within the 3 months before Screening
• Subject has clinically significant unstable cardiac disease (e.g., cardiac disease requiring active management, such as symptomatic arrhythmia, unstable angina, or NYHA class III or IV congestive heart failure)
• Subject has a history of allergy or sensitivity to study drug (including excipients) or other iminosugars (e.g., miglustat, miglitol)
• Subject requires a concomitant medication prohibited by the protocol: Glyset® (miglitol), or Zavesca® (miglustat)
• Any investigational/experimental drug or device within 30 days of Screening, except for use of investigational ERT for Fabry Disease
• Subject has any intercurrent illness or condition that may preclude the subject from fulfilling the protocol requirements or suggests to the investigator that the potential subject may have an unacceptable risk by participating in this study