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Completed

NCT Number: NCT01489995

Migalastat Food Effect Study

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.

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Key information

Conditions

Fabry Disease Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Cardiovascular Diseases Central Nervous System Diseases Cerebral Small Vessel Diseases Cerebrovascular Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Lipidoses Lysosomal Storage Diseases Lysosomal Storage Diseases, Nervous System Metabolic Diseases Metabolism, Inborn Errors Nervous System Diseases Nutritional and Metabolic Diseases Sphingolipidoses Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Austin, Texas, 78744, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A (migalastat)

Drug

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

B (migalastat)

Drug

150 mg migalastat HCl with simultaneous consumption of a glucose drink

C (migalastat)

Drug

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

D (migalastat)

Drug

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

E (migalastat)

Drug

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

Primary outcomes

  1. Maximum observed plasma concentration of migalastat HCl after a single dose

    Time frame: 5 weeks (60 PK timepoints)

    Cmax

  2. Time of occurence of maximum observed plasma concentration of migalastat HCl after a single dose

    Time frame: 5 weeks (60 PK timepoints)

    tmax

  3. 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)

    AUC (0 to infinity)

  4. Terminal phase half life of migalastat HCl after a single dose

    Time frame: 5 weeks (60 PK timepoints)

    t1/2

  5. Apparent clearance following oral dosing of migalastat HCl after a single dose

    Time frame: 5 weeks (60 PK timepoints)

    CL/F

  6. 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)

    AUC (0 to t)

Secondary outcomes

  1. Adverse Events

    Time frame: 5 weeks

  2. Clinical Laboratory Tests

    Time frame: 5 weeks

  3. Vital Signs

    Time frame: 5 weeks

  4. ECGs

    Time frame: 5 weeks

  5. Physical Examination

    Time frame: 5 weeks

Sponsors and collaborators

Lead sponsor

Amicus Therapeutics

Industry

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 12, 2011
Registry last updated
Dec 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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