Migalastat Food Effect Study

Fabry Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01489995
• Other study ID #: 116050
• Status: Completed
• Phase: Phase 1
• First received: October 20, 2011
• Last updated: December 17, 2013
• Start date: October 2011
• Est. completion date: December 2011

Study information

• Verified date: December 2013
• Source: Amicus Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fabry Disease

Intervention

Drug:
• A (migalastat)
150 mg migalastat HCl in the fasting state (reference arm)
• B (migalastat)
150 mg migalastat HCl with simultaneous consumption of a glucose drink
• C (migalastat)
150 mg migalastat HCl 1 hour before consumption of a high fat meal
• D (migalastat)
150 mg migalastat HCl 1 hour before consumption of a light meal
• E (migalastat)
150 mg migalastat HCl 1 hour after consumption of a light meal

Locations

Country	Name	City	State
United States	GSK Investigational Site	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Amicus Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration of migalastat HCl after a single dose	Cmax	5 weeks (60 PK timepoints)	No
Primary	Time of occurence of maximum observed plasma concentration of migalastat HCl after a single dose	tmax	5 weeks (60 PK timepoints)	No
Primary	Area under the plasma concentration-time curve of migalastat HCl after a single dose from time 0 (before dosing) to infinity	AUC (0 to infinity)	5 weeks (60 PK timepoints)	No
Primary	Terminal phase half life of migalastat HCl after a single dose	t1/2	5 weeks (60 PK timepoints)	No
Primary	Apparent clearance following oral dosing of migalastat HCl after a single dose	CL/F	5 weeks (60 PK timepoints)	No
Primary	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	AUC (0 to t)	5 weeks (60 PK timepoints)	No
Secondary	Adverse Events		5 weeks	No
Secondary	Clinical Laboratory Tests		5 weeks	No
Secondary	Vital Signs		5 weeks	No
Secondary	ECGs		5 weeks	No
Secondary	Physical Examination		5 weeks	No