AN OPEN-LABEL PHASE 2A STUDY TO INVESTIGATE DRUG-DRUG INTERACTIONS BETWEEN AT1001 (MIGALASTAT HYDROCHLORIDE) AND AGALSIDASE IN SUBJECTS WITH FABRY DISEASE

Amicus Therapeutics, Inc.0 sites18 target enrollmentMay 21, 2012

Overview

No summary available.

Registry

who.int

Start Date

May 21, 2012

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

•1\. Male, diagnosed with Fabry disease and between 18 and 65 years of age, inclusive :
•2\. Body Mass Index (BMI) between 18\-35
•3\. Subject initiated treatment with agalsidase at least 1 month, having received at least two infusions, before Screening Visit
•4\. Subject’s dose level, dosing regimen and form (i.e., alfa or beta) of agalsidase have been stable (stable dose defined as not varying by more than ± 20%) for at least 1 month before Screening Visit
•5\. Subject has a estimated creatinine clearance \= 50 mL/min at Screening; creatinine clearance to be estimated using the 4\-parameter MDRD equation:
•eGFR (mL/min/1\.73 m2\) \= 186 x (Scr)\-1\.154 x (Age)\-0\.203 x (0\.742 if female) x (1\.212 if African\-American)
•6\. Subject agrees to use medically accepted methods of contraception during the study and for 30 days after study completion
•7\. Subject is willing and able to provide written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•1\. Subject has had a documented transient ischemic attack, ischemic stroke, unstable angina, or myocardial infarction within the 3 months before Screening
•2\. 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)
•3\. Subject has a history of allergy or sensitivity to study drug (including excipients) or other iminosugars (e.g., miglustat, miglitol)
•4\. Subject requires a concomitant medication prohibited by the protocol: Glyset® (miglitol), or Zavesca® (miglustat)
•5\. Any investigational/experimental drug or device within 30 days of Screening
•6\. Subject is currently being treated with or has previously received AT1001
•7\. 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