Status:
COMPLETED
Drug-Drug Interaction Study Between AT1001 (Migalastat Hydrochloride) and Agalsidase in Participants With Fabry Disease
Lead Sponsor:
Amicus Therapeutics
Conditions:
Fabry Disease
Eligibility:
MALE
18-65 years
Phase:
PHASE2
Brief Summary
The objective was to determine the effects of a single dose of migalastat hydrochloride (HCl) (migalastat) 150 and 450 milligrams (mg) on the safety and plasma pharmacokinetics (PK) of agalsidase and ...
Detailed Description
This open-label study was conducted in 2 stages (Stage 1, Stage 2). Stage 1 included migalastat 150 mg; Stage 2 included migalastat 450 mg. Each dose of migalastat was selected to evaluate interaction...
Eligibility Criteria
Inclusion
- Male diagnosed with Fabry disease and between 18 and 65 years of age, inclusive
- Body mass index between 18-35 kg per meter squared
- Had initiated treatment with agalsidase at least 1 month prior to screening, and had received at least 2 infusions before screening
- Had stable dose level, dosing regimen, and form of agalsidase for at least 1 month before screening
- Had an estimated creatinine clearance greater than or equal to 50 milliliters (mL)/minute at screening
- Agreed to use medically accepted methods of contraception during the study and for 30 days after study completion
- Were willing and able to provide written informed consent
Exclusion
- Had a documented transient ischemic attack, ischemic stroke, unstable angina, or myocardial infarction within the 3 months before screening
- Had clinically significant unstable cardiac disease (for example, cardiac disease requiring active management, such as symptomatic arrhythmia, unstable angina, or New York Heart Association class III or IV congestive heart failure)
- History of allergy or sensitivity to study drug (including excipients) or other iminosugars (such as miglustat, miglitol)
- Required 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 enzyme replacement therapy for Fabry disease
- Had any intercurrent illness or condition that might have precluded the participant from fulfilling the protocol requirements or suggested to the investigator that the potential participant might have had an unacceptable risk by participating in this study
Key Trial Info
Start Date :
February 2 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01196871
Start Date
February 2 2011
End Date
October 9 2012
Last Update
December 19 2018
Active Locations (10)
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1
Birmingham, Alabama, United States, 35294
2
Decatur, Georgia, United States, 30033
3
Iowa City, Iowa, United States, 52242
4
Kansas City, Kansas, United States, 66160