NCT01489995

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 12, 2011

Completed
Last Updated

December 18, 2013

Status Verified

December 1, 2013

Enrollment Period

2 months

First QC Date

October 20, 2011

Last Update Submit

December 17, 2013

Conditions

Fabry Disease

Keywords

Food effectGR181413AAT1001migalastat hydrochlorideLysosomal storage disordersPharmacokinetics

Outcome Measures

Primary Outcomes (6)

  • Maximum observed plasma concentration of migalastat HCl after a single dose

    Cmax

    5 weeks (60 PK timepoints)

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

    tmax

    5 weeks (60 PK timepoints)

  • 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)

  • Terminal phase half life of migalastat HCl after a single dose

    t1/2

    5 weeks (60 PK timepoints)

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

    CL/F

    5 weeks (60 PK timepoints)

  • 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)

Secondary Outcomes (5)

  • Adverse Events

    5 weeks

  • Clinical Laboratory Tests

    5 weeks

  • Vital Signs

    5 weeks

  • ECGs

    5 weeks

  • Physical Examination

    5 weeks

Study Arms (5)

Reference

EXPERIMENTAL

Fasted

Drug: A (migalastat)

Glucose Drink

EXPERIMENTAL

Fed

Drug: B (migalastat)

Before High Fat Meal

EXPERIMENTAL

Fed

Drug: C (migalastat)

Before Light Meal

EXPERIMENTAL

Fed

Drug: D (migalastat)

After Light Meal

EXPERIMENTAL

Fed

Drug: E (migalastat)

Interventions

A (migalastat)DRUG

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

Reference
B (migalastat)DRUG

150 mg migalastat HCl with simultaneous consumption of a glucose drink

Glucose Drink
C (migalastat)DRUG

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

Before High Fat Meal
D (migalastat)DRUG

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

Before Light Meal
E (migalastat)DRUG

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

After Light Meal

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female aged 18 to 65 years inclusive
  • Healthy, as determined by study physician
  • Capable of giving informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Austin, Texas, 78744, United States

Location

MeSH Terms

Conditions

Fabry DiseaseLysosomal Storage Diseases

Interventions

migalastatFumigant 93

Condition Hierarchy (Ancestors)

SphingolipidosesLysosomal Storage Diseases, Nervous SystemBrain Diseases, Metabolic, InbornBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCerebral Small Vessel DiseasesCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolism, Inborn ErrorsLipidosesLipid Metabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism Disorders

Study Officials

  • Medical Monitor, Clinical Research

    AmicusTherapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2011

First Posted

December 12, 2011

Study Start

October 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 18, 2013

Record last verified: 2013-12

Locations

US(1)