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Migalastat Food Effect Study

NCT01489995 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-12-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

A (migalastat)

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

DRUG

B (migalastat)

150 mg migalastat HCl with simultaneous consumption of a glucose drink

DRUG

C (migalastat)

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

DRUG

D (migalastat)

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

DRUG

E (migalastat)

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

Sponsors & Collaborators

  • Amicus Therapeutics

    lead INDUSTRY

Principal Investigators

  • Medical Monitor, Clinical Research · AmicusTherapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01489995 on ClinicalTrials.gov