Status:
COMPLETED
Migalastat Food Effect Study
Lead Sponsor:
Amicus Therapeutics
Conditions:
Fabry Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
A 5-period crossover study to evaluate the effect of meal type and timing on migalastat HCl pharmacokinetics in healthy male and female subjects. Subjects will be randomly assigned to 1 of 5 treatment...
Detailed Description
This is a Phase 1, randomized, open-label, 5-period crossover study to evaluate the effect of meal type and timing on migalastat HCl pharmacokinetics in healthy male and female subjects between the ag...
Eligibility Criteria
Inclusion
- Male or Female aged 18 to 65 years inclusive
- Healthy, as determined by study physician
- Capable of giving informed consent
Exclusion
- Positive for HIV or Hepatitis B and/or C viruses
- History of drug or alcohol abuse or addiction within 2 years
- Smoker or consumes tobacco products
- Participation in a clinical trial within 30 days of scheduled first dose
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01489995
Start Date
October 1 2011
End Date
December 1 2011
Last Update
December 18 2013
Active Locations (1)
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1
GSK Investigational Site
Austin, Texas, United States, 78744