Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01196871 · ClinicalTrials.gov registry record · Phase 2

Drug-Drug Interaction Study Between AT1001 (Migalastat Hydrochloride) and Agalsidase in Participants With Fabry Disease

A Phase 2 study of Fabry Disease, sponsored by Amicus Therapeutics.

Completed
Registry status
Phase 2
Development phase
20
Enrollment target
10
Study locations

NCT01196871 is a Phase 2 study of Fabry Disease that has completed, run by Amicus Therapeutics. The registered enrollment target is 20 participants, below the 542-participant average among 32 other Fabry Disease trials with a reported enrollment target (96% lower). The trial reports 10 study locations across 6 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01196871, a Phase 2 study of Fabry Disease, has completed, sponsored by Amicus Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
20 participants
Enrollment target
10
Study locations

Study Summary

The objective was to determine the effects of a single dose of migalastat hydrochloride (HCl) (migalastat) 150 and 450 milligrams (mg) on the safety and plasma pharmacokinetics (PK) of agalsidase and the effects of agalsidase on the safety and PK of migalastat 150 mg.

Conditions Studied

Fabry Disease

Interventions

  • DRUG Migalastat HCl
  • BIOLOGICAL Agalsidase Beta
  • BIOLOGICAL Agalsidase Alfa

Study Locations (10)

Other

  • - Nedlands
  • - Parkville
  • - Edegem
  • - Montreal
  • - Amsterdam

Alabama

  • - Birmingham

Georgia

  • - Decatur

Iowa

  • - Iowa City

Kansas

  • - Kansas City

Virginia

  • - Springfield

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2011-02-02
Est. Completion 2012-10-09
Phase Phase 2

Sponsor

Amicus Therapeutics

34 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01196871

The ClinicalTrials.gov registry entry for NCT01196871 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 542-participant average among 32 other Fabry Disease trials with a reported enrollment target (96% lower). The listed sponsor is Amicus Therapeutics, which has 34 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Fabry Disease appearing as the primary indexed condition, and to 3 interventions - of which Migalastat HCl is the first listed.

NCT01196871 reports 10 study locations spanning 6 distinct geographic areas - top geographies include Other, Alabama, Georgia.

Frequently Asked Questions

What is clinical trial NCT01196871 about?

NCT01196871 is a clinical study titled "Drug-Drug Interaction Study Between AT1001 (Migalastat Hydrochloride) and Agalsidase in Participants With Fabry Disease". The objective was to determine the effects of a single dose of migalastat hydrochloride (HCl) (migalastat) 150 and 450 milligrams (mg) on the safety and plasma pharmacokinetics (PK) of agalsidase and the effects of agalsidase on the safety and PK of migalastat 150 mg.

What is the current status of trial NCT01196871?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2011-02-02. Estimated completion is 2012-10-09.

What conditions does trial NCT01196871 study?

This clinical trial studies the following conditions: Fabry Disease.

What interventions are being tested in trial NCT01196871?

The interventions under investigation include: Migalastat HCl (DRUG), Agalsidase Beta (BIOLOGICAL), Agalsidase Alfa (BIOLOGICAL).

Who is sponsoring clinical trial NCT01196871?

This trial is sponsored by Amicus Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01196871 being conducted?

This trial has 10 study locations across Alabama, Georgia, Iowa, Kansas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Fabry Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Fabry Disease

All registered trials for this condition

Alabama

All trials with a study site in Alabama

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.