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NCT01730469 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics of AT1001 (Migalastat HCl) in Healthy Subjects and Subjects With Impaired Renal Function
A Phase 1 study of Fabry Disease, sponsored by Amicus Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 4
- Study locations
NCT01730469: Completed Phase 1 study of Fabry Disease, sponsored by Amicus Therapeutics.
NCT01730469 is a Phase 1 study of Fabry Disease that has completed, run by Amicus Therapeutics. The registered enrollment target is 32 participants, below the 542-participant average among 32 other Fabry Disease trials with a reported enrollment target (94% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01730469, a Phase 1 study of Fabry Disease, has completed, sponsored by Amicus Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 4
- Study locations
Study Summary
This study will assess the safety, tolerability, and pharmacokinetics (PK) study of a single dose of 150 mg AT1001 (migalastat HCl, GR181413A) administered orally to healthy subjects with normal renal function and to subjects with mild, moderate, and severe renal impairment.
Primary Outcome
Adverse events will be evaluated from Day 1 to the end of study (Day 10 +1).
Conditions Studied
Interventions
- DRUG AT1001 150 mg
Study Locations (4)
Florida
- GSK Investigational Site - Miami
- GSK Investigational Site - Miami
- GSK Investigational Site - Orlando
California
- GSK Investigational Site - Costa Mesa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2011-08 |
| Est. Completion | 2012-04 |
| Phase | Phase 1 |
What the finished NCT01730469 record still lists
NCT01730469 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 542-participant average among 32 other Fabry Disease trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Fabry Disease appearing as the primary indexed condition, and to 1 intervention - of which AT1001 150 mg is the first listed.
NCT01730469 reports a single indexed study location in Florida, California.
Frequently Asked Questions
What is clinical trial NCT01730469 about?
NCT01730469 is a clinical study titled "Safety and Pharmacokinetics of AT1001 (Migalastat HCl) in Healthy Subjects and Subjects With Impaired Renal Function". This study will assess the safety, tolerability, and pharmacokinetics (PK) study of a single dose of 150 mg AT1001 (migalastat HCl, GR181413A) administered orally to healthy subjects with normal renal function and to subjects with mild, moderate, and severe renal impairment.
What is the current status of trial NCT01730469?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2011-08. Estimated completion is 2012-04.
What conditions does trial NCT01730469 study?
This clinical trial studies the following conditions: Fabry Disease.
What interventions are being tested in trial NCT01730469?
The interventions under investigation include: AT1001 150 mg (DRUG).
Who is sponsoring clinical trial NCT01730469?
This trial is sponsored by Amicus Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01730469 being conducted?
This trial has 4 study locations across California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Fabry Disease
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Where NCT01730469's enrollment target sits among peer trials
32 16th of 32 higher than 17 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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