Clinical trial NCT01489995: Migalastat Food Effect Study
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fabry Disease
Keywords: Food effect
GR181413A
AT1001
migalastat hydrochloride
Lysosomal storage disorders
Pharmacokinetics
Lead sponsor: Amicus Therapeutics
Sponsor class: INDUSTRY
First posted: 2011-12-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Maximum observed plasma concentration of migalastat HCl after a single dose
timeFrame: 5 weeks (60 PK timepoints)
measure: Time of occurence of maximum observed plasma concentration of migalastat HCl after a single dose
timeFrame: 5 weeks (60 PK timepoints)
measure: Area under the plasma concentration-time curve of migalastat HCl after a single dose from time 0 (before dosing) to infinity
timeFrame: 5 weeks (60 PK timepoints)
measure: Terminal phase half life of migalastat HCl after a single dose
timeFrame: 5 weeks (60 PK timepoints)
measure: Apparent clearance following oral dosing of migalastat HCl after a single dose
timeFrame: 5 weeks (60 PK timepoints)
measure: 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
timeFrame: 5 weeks (60 PK timepoints)
Secondary outcomes:
measure: Adverse Events
timeFrame: 5 weeks
measure: Clinical Laboratory Tests
timeFrame: 5 weeks
measure: Vital Signs
timeFrame: 5 weeks
measure: ECGs
timeFrame: 5 weeks
measure: Physical Examination
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
Study officials:
affiliation: AmicusTherapeutics
name: Medical Monitor, Clinical Research
role: STUDY_DIRECTOR
References: