Migalastat Food Effect Study

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Amicus Therapeutics
• Treatments: 1-Deoxynojirimycin

Criteria

Inclusion Criteria:

• Male or Female aged 18 to 65 years inclusive

• Healthy, as determined by study physician

• Capable of giving informed consent

Exclusion Criteria:

• 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