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NCT00875160 · ClinicalTrials.gov registry record · Phase 1
A Study in Type 1 Gaucher Patients to Evaluate the Pharmacokinetics, Safety and Pharmacodynamics of AT2101
A Phase 1 study, sponsored by Amicus Therapeutics.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT00875160 is a Phase 1 study that was terminated before completion, run by Amicus Therapeutics. The registered enrollment target is 1 participants.
The verdict
NCT00875160, a Phase 1 study, was terminated before completion, sponsored by Amicus Therapeutics.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
This is an open-label study designed to assess if AT2101 is safe in patients with Gaucher disease and how AT2101 gets through the body after it is taken by mouth. The study is being offered to adult patients with type 1 Gaucher disease who are currently receiving a stable dose of enzyme replacement therapy (ERT) with imiglucerase. During the study, subjects will not be receiving ERT (up to 35 days). The study consists of a screening period (\~14 days), a treatment period (12 days) and a follow-up period (7 days after last dose). At two points in the study, subjects will be housed in an in-patient treatment facility for 3 days/2 nights to accommodate all necessary blood draws.
Interventions
- DRUG AT2101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2009-04 |
| Est. Completion | 2009-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00875160
The ClinicalTrials.gov registry entry for NCT00875160 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amicus Therapeutics, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which AT2101 is the first listed.
NCT00875160 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00875160 about?
NCT00875160 is a clinical study titled "A Study in Type 1 Gaucher Patients to Evaluate the Pharmacokinetics, Safety and Pharmacodynamics of AT2101". This is an open-label study designed to assess if AT2101 is safe in patients with Gaucher disease and how AT2101 gets through the body after it is taken by mouth. The study is being offered to adult patients with type 1 Gaucher disease who are currently receiving a stable dose of enzyme replacement ...
What is the current status of trial NCT00875160?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2009-04. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00875160?
The interventions under investigation include: AT2101 (DRUG).
Who is sponsoring clinical trial NCT00875160?
This trial is sponsored by Amicus Therapeutics, which has 34 total clinical trials registered on ClinicalTrials.gov.
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