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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: Completed Phase 2 study of Fabry Disease, sponsored by Amicus Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This measure characterized the effects of migalastat on the plasma PK of agalsidase by measurement of the active α-Gal A enzyme level in plasma using a qualified assay that measured the rate of enzyme activity using an artificial, fluorescent substrate. The agalsidase plasma PK parameter values for AUC extrapolated from time 0 to infinity (AUCinfinity) and AUC to the last time point at which concentration is quantified (AUC0-t) are reported in hr\*\[nanomoles/hr/milliliter\] (hr\*\[nmol/hr/mL\])
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-02-02 |
| Est. Completion | 2012-10-09 |
| Phase | Phase 2 |
What the finished NCT01196871 record still lists
NCT01196871 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 542-participant average among 32 other Fabry Disease trials with a reported enrollment target (96% lower).
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 lists 10 locations in 6 states (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
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Where NCT01196871's enrollment target sits among peer trials
20 23rd of 32 higher than 9 of 32 other Fabry Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fabry Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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