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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01730469
The ClinicalTrials.gov registry entry for NCT01730469 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 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 (94% 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 1 intervention - of which AT1001 150 mg is the first listed.
NCT01730469 reports 4 study locations spanning 2 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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