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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: Completed Phase 1 study, sponsored by Eisai.
NCT01294540 is a Phase 1 study that has completed, run by Eisai. The registered enrollment target is 73 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01294540 record still lists
NCT01294540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01294540 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01294540's enrollment target sits among peer trials
73 732nd of 2000 higher than 1,265 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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