Trial Entry Criteria

Consult with a healthcare professional to see if you meet the entry criteria.
 

How do I qualify?
 

Inclusion Criteria:

  • Male diagnosed with Fabry disease and between 18 and 65 years of age, inclusive
  • Body mass index between 18-35
  • Participant initiated treatment with agalsidase (ERT) at least 1 month, having received at least 2 infusions, before the screening visit
  • Participant's dose level, dosing regimen and form of agalsidase (ERT) have been stable for at least 1 month before screening visit
  • Participant has an estimated creatinine clearance greater than or equal to 50mL/min at screening
  • Participant agrees to use medically-accepted methods of contraception during the study and for 30 days after study completion
  • Participant is willing and able to provide written informed consent
 

Exclusion Criteria:

  • Participant has had a documented transient ischemic attack, ischemic stroke, unstable angina, or myocardial infarction within the 3 months before screening
  • Participant 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)
  • Participant has a history of allergy or sensitivity to study drug (including excipients) or other iminosugars (e.g., miglustat, miglitol)
  • Participant 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 agalsidase (ERT) for Fabry disease
  • Participant 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
           

* Glyset is a trademark of Bayer company. Zavesca is a trademark of Actelion Pharmaceuticals Ltd.