NCT01489995

Migalastat Food Effect Study

A Randomized, Open-Label, 5-Period Crossover Study to Evaluate the Effect of Meal Type and Timing on the Pharmacokinetics of Migalastat Hydrochloride in Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Amicus Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

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 ages of 18 and 65 years. A total of 20 subjects will be enrolled such that approximately 14 evaluable subjects complete dosing and critical assessments. Subjects will be randomly assigned to 1 of 5 treatment sequences and will receive each treatment over the course of 5 successive weekly periods including a single dose of migalastat HCl 150 mg in the fasting state as the reference treatment. There will be at least a 7-day washout period between each dose of migalastat HCl and a follow-up visit approximately 7 to 10 days after the last dose in Period 5. All subjects will be screened within 28 days of admission to the clinical unit. In each period, subjects will check in to the clinical unit the day prior to drug administration and have relevant assessments to ensure continued eligibility for dose administration. On Day 1 of each period, subjects will receive a single dose of migalastat HCl within 1 of the following 5 treatment regimens as follows: * 150 mg migalastat HCl in the fasting state (reference arm) * 150 mg migalastat HCl with simultaneous consumption of a glucose drink * 150 mg migalastat HCl 1 hour before consumption of a high fat meal * 150 mg migalastat HCl 1 hour before consumption of a light meal * 150 mg migalastat HCl 1 hour after consumption of a light meal Subjects will be confined to the clinical unit for 24 hours after dosing with serial blood samples collected for PK analysis. Safety will be assessed throughout the study by monitoring clinical laboratory tests, ECGs, physical examinations, vital signs, and AEs.

Conditions

• Fabry Disease

Interventions

Type	Name	Description
DRUG	A (migalastat)	150 mg migalastat HCl in the fasting state (reference arm)
DRUG	B (migalastat)	150 mg migalastat HCl with simultaneous consumption of a glucose drink
DRUG	C (migalastat)	150 mg migalastat HCl 1 hour before consumption of a high fat meal
DRUG	D (migalastat)	150 mg migalastat HCl 1 hour before consumption of a light meal
DRUG	E (migalastat)	150 mg migalastat HCl 1 hour after consumption of a light meal

Timeline

• Start date: 2011-10-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-12-12
• Last updated: 2013-12-18

Locations

1 site across 1 country: United States