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Migalastat Food Effect Study

NCT ID: NCT01489995

Last Updated: 2013-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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

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Fabry Disease

Keywords

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Food effect GR181413A AT1001 migalastat hydrochloride Lysosomal storage disorders Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Reference

Fasted

Group Type EXPERIMENTAL

A (migalastat)

Intervention Type DRUG

150 mg migalastat HCl in the fasting state (reference arm)

Glucose Drink

Fed

Group Type EXPERIMENTAL

B (migalastat)

Intervention Type DRUG

150 mg migalastat HCl with simultaneous consumption of a glucose drink

Before High Fat Meal

Fed

Group Type EXPERIMENTAL

C (migalastat)

Intervention Type DRUG

150 mg migalastat HCl 1 hour before consumption of a high fat meal

Before Light Meal

Fed

Group Type EXPERIMENTAL

D (migalastat)

Intervention Type DRUG

150 mg migalastat HCl 1 hour before consumption of a light meal

After Light Meal

Fed

Group Type EXPERIMENTAL

E (migalastat)

Intervention Type DRUG

150 mg migalastat HCl 1 hour after consumption of a light meal

Interventions

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A (migalastat)

150 mg migalastat HCl in the fasting state (reference arm)

Intervention Type DRUG

B (migalastat)

150 mg migalastat HCl with simultaneous consumption of a glucose drink

Intervention Type DRUG

C (migalastat)

150 mg migalastat HCl 1 hour before consumption of a high fat meal

Intervention Type DRUG

D (migalastat)

150 mg migalastat HCl 1 hour before consumption of a light meal

Intervention Type DRUG

E (migalastat)

150 mg migalastat HCl 1 hour after consumption of a light meal

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Amicus Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor, Clinical Research

Role: STUDY_DIRECTOR

AmicusTherapeutics

Locations

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GSK Investigational Site

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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116050

Identifier Type: -

Identifier Source: org_study_id