Migalastat Food Effect Study

Completed · Phase 1

Conditions studied: Fabry Disease

In brief

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 sequences and will receive each treatment over the course of 5 weekly periods.

Key facts

Study ID

NCT01489995

Run by

Amicus Therapeutics

People needed

20

Starts

2011-10-01

Expected to finish

2011-12-01

Last updated by the study team

2013-12-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or Female aged 18 to 65 years inclusive
• Healthy, as determined by study physician
• Capable of giving informed consent

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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