Migalastat Food Effect Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amicus Therapeutics
ClinicalTrials.gov Identifier:
NCT01489995
First received: October 20, 2011
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Fabry Disease
Drug: A (migalastat)
Drug: B (migalastat)
Drug: C (migalastat)
Drug: D (migalastat)
Drug: E (migalastat)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Amicus Therapeutics:

Primary Outcome Measures:
  • Maximum observed plasma concentration of migalastat HCl after a single dose [ Time Frame: 5 weeks (60 PK timepoints) ] [ Designated as safety issue: No ]
    Cmax

  • Time of occurence of maximum observed plasma concentration of migalastat HCl after a single dose [ Time Frame: 5 weeks (60 PK timepoints) ] [ Designated as safety issue: No ]
    tmax

  • Area under the plasma concentration-time curve of migalastat HCl after a single dose from time 0 (before dosing) to infinity [ Time Frame: 5 weeks (60 PK timepoints) ] [ Designated as safety issue: No ]
    AUC (0 to infinity)

  • Terminal phase half life of migalastat HCl after a single dose [ Time Frame: 5 weeks (60 PK timepoints) ] [ Designated as safety issue: No ]
    t1/2

  • Apparent clearance following oral dosing of migalastat HCl after a single dose [ Time Frame: 5 weeks (60 PK timepoints) ] [ Designated as safety issue: No ]
    CL/F

  • Area under the plasma concentration-time curve of migalastat HCl after a single dose from time 0 (before dosing) to the time of the last quantifiable concentration [ Time Frame: 5 weeks (60 PK timepoints) ] [ Designated as safety issue: No ]
    AUC (0 to t)


Secondary Outcome Measures:
  • Adverse Events [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  • Clinical Laboratory Tests [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  • Vital Signs [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  • ECGs [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  • Physical Examination [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: October 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reference
Fasted
Drug: A (migalastat)
150 mg migalastat HCl in the fasting state (reference arm)
Experimental: Glucose Drink
Fed
Drug: B (migalastat)
150 mg migalastat HCl with simultaneous consumption of a glucose drink
Experimental: Before High Fat Meal
Fed
Drug: C (migalastat)
150 mg migalastat HCl 1 hour before consumption of a high fat meal
Experimental: Before Light Meal
Fed
Drug: D (migalastat)
150 mg migalastat HCl 1 hour before consumption of a light meal
Experimental: After Light Meal
Fed
Drug: E (migalastat)
150 mg migalastat HCl 1 hour after consumption of a light meal

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489995

Locations
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78744
Sponsors and Collaborators
Amicus Therapeutics
Investigators
Study Director: Medical Monitor, Clinical Research AmicusTherapeutics
  More Information

No publications provided

Responsible Party: Amicus Therapeutics
ClinicalTrials.gov Identifier: NCT01489995     History of Changes
Other Study ID Numbers: 116050
Study First Received: October 20, 2011
Last Updated: December 17, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Amicus Therapeutics:
Food effect
GR181413A
AT1001
migalastat hydrochloride
Lysosomal storage disorders
Pharmacokinetics

Additional relevant MeSH terms:
Fabry Disease
Sphingolipidoses
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Genetic Diseases, X-Linked
Genetic Diseases, Inborn
Metabolism, Inborn Errors
Lipidoses
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases
Metabolic Diseases
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on April 16, 2014