Drug-Drug Interaction Study Between AT1001 and Agalsidase in Subjects With Fabry Disease

This study has been completed.

Sponsor:

Collaborator:

GlaxoSmithKline

Information provided by (Responsible Party):

Amicus Therapeutics

ClinicalTrials.gov Identifier:

NCT01196871

First received: September 7, 2010

Last updated: December 18, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 7, 2010

Last Updated Date

December 18, 2012

Start Date ^ICMJE

February 2011

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Plasma pharmacokinetics [ Time Frame: Over 24-hour period after dosing ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01196871 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Drug-Drug Interaction Study Between AT1001 and Agalsidase in Subjects With Fabry Disease

Official Title ^ICMJE

An Open-label Phase 2A Study to Investigate Drug-Drug Interactions Between AT1001 and Agalsidase in Subjects With Fabry Disease.

Brief Summary

The purpose of this study is to determine the effects of AT1001 on the safety of agalsidase, and the effects of agalsidase on the safety of AT1001.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Fabry Disease

Intervention ^ICMJE

Drug: AT1001

Capsules, single dose

Other Name: migalastat hydrochloride

Study Arm (s)

Experimental: Low dose A
Lower dose of AT1001 with Fabrazyme.

Intervention: Drug: AT1001
Experimental: High dose A
Higher dose of AT1001 with Fabrazyme.

Intervention: Drug: AT1001
Experimental: Low dose B
Low dose AT1001 with Replagal

Intervention: Drug: AT1001
Experimental: High dose B
Higher dose of AT1001 with Replagal.

Intervention: Drug: AT1001

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2012

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male diagnosed with Fabry disease and between 18 and 65 years of age, inclusive
Body mass index between 18-35
Subject initiated treatment with agalsidase at lease one month, having received at least two infusions, before the Screening Visit
Subject's dose level, dosing regimen and form of agalsidase have been stable for at least one month before Screening Visit
Subject has an estimated creatinine clearance greater than or equal to 50mL/min at Screening
Subject agrees to use medically-accepted methods of contraception during the study and for 30 days after study completion
Subject is willing and able to provide written informed consent

Exclusion Criteria:

Subject has had a documented transient ischemic attack, ischemic stroke, unstable angina, or myocardial infarction within the 3 months before Screening
Subject has clinically significant unstable cardiac disease (e.g., cardiac disease requiring active management, such as symptomatic arrhythmia, unstable angina, or NYHA class III or IV congestive heart failure)
Subject has a history of allergy or sensitivity to study drug (including excipients) or other iminosugars (e.g., miglustat, miglitol)
Subject requires a concomitant medication prohibited by the protocol: Glyset® (miglitol), or Zavesca® (miglustat)
Any investigational/experimental drug or device within 30 days of Screening, except for use of investigational ERT for Fabry Disease
Subject has any intercurrent illness or condition that may preclude the subject from fulfilling the protocol requirements or suggests to the investigator that the potential subject may have an unacceptable risk by participating in this study

Gender

Male

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Belgium, Canada, Netherlands

Administrative Information

NCT Number ^ICMJE

NCT01196871

Other Study ID Numbers ^ICMJE

AT1001-013

Has Data Monitoring Committee

Responsible Party

Amicus Therapeutics

Study Sponsor ^ICMJE

Amicus Therapeutics

Collaborators ^ICMJE

GlaxoSmithKline

Investigators ^ICMJE

Study Director:

Medical Monitor Clinical Research

Amicus Therapeutics

Information Provided By

Amicus Therapeutics

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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