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NCT01294540 · ClinicalTrials.gov registry record · Phase 1
Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2609 in Healthy Subjects and an Elderly Cohort
A Phase 1 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 73
- Enrollment target
NCT01294540 is a Phase 1 study that has completed, run by Eisai. The registered enrollment target is 73 participants.
The verdict
NCT01294540, a Phase 1 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 73 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of E2609 when administered as single doses to healthy adult volunteers and healthy elderly subjects. The study will consist of 2 parts:(1) a single dose in healthy adult volunteers, at doses up to 800 mg or the maximum dose that can be tolerated, (2) a single dose of 50 mg in healthy elderly volunteers.
Interventions
- DRUG Placebo
- DRUG Drug: E2609
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2010-12 |
| Est. Completion | 2011-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01294540
The ClinicalTrials.gov registry entry for NCT01294540 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01294540 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01294540 about?
NCT01294540 is a clinical study titled "Evaluation of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2609 in Healthy Subjects and an Elderly Cohort". The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of E2609 when administered as single doses to healthy adult volunteers and healthy elderly subjects. The study will consist of 2 parts:(1) a single dose in healthy adult volunteers, at doses up ...
What is the current status of trial NCT01294540?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 73 participants. The study started on 2010-12. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01294540?
The interventions under investigation include: Placebo (DRUG), Drug: E2609 (DRUG).
Who is sponsoring clinical trial NCT01294540?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
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