Migalastat Food Effect Study

Amicus Therapeutics

Status and phase: Completed; Phase 1

Conditions: Fabry Disease

Treatments: Drug: E (migalastat); Drug: B (migalastat); Drug: D (migalastat); Drug: A (migalastat); Drug: C (migalastat)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01489995

116050

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 5 patient groups

Reference

Experimental group

Description:

Fasted

Treatment:

Drug: A (migalastat)

Glucose Drink

Experimental group

Description:

Fed

Treatment:

Drug: B (migalastat)

Before High Fat Meal

Experimental group

Description:

Fed

Treatment:

Drug: C (migalastat)

Before Light Meal

Experimental group

Description:

Fed

Treatment:

Drug: D (migalastat)

After Light Meal

Experimental group

Description:

Fed

Treatment:

Drug: E (migalastat)