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NCT01463098 · ClinicalTrials.gov registry record · Phase 1
A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006
A Phase 1 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 122
- Enrollment target
NCT01463098: Completed Phase 1 study, sponsored by Eisai.
NCT01463098 is a Phase 1 study that has completed, run by Eisai. The registered enrollment target is 122 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (103% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01463098, a Phase 1 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 122 participants
- Enrollment target
Study Summary
Part A: The purpose of this study is to evaluate the safety and tolerability of single oral doses of E2006 administered in the morning to healthy male and female subjects. Part B: The purpose of this study is to evaluate selected pharmacodynamic (PD) parameters (e.g., polysomnographically defined sleep measures) with regard to dose response in subjects with primary insomnia following single oral dosing of E2006 in the evening approximately 30 minutes prior to the sleep period, compared with 10 mg zolpidem and placebo.
Interventions
- DRUG E2006 1.0 mg
- DRUG E2006 2.5 mg
- DRUG E2006 5.0 mg
- DRUG E2006 10.0 mg
- DRUG E2006 25.0 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2011-10-05 |
| Est. Completion | 2012-08-11 |
| Phase | Phase 1 |
What the finished NCT01463098 record still lists
NCT01463098 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (103% higher).
The record links to 0 conditions, and to 5 interventions - of which E2006 1.0 mg is the first listed.
NCT01463098 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01463098 about?
NCT01463098 is a clinical study titled "A 2-Part Single Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006". Part A: The purpose of this study is to evaluate the safety and tolerability of single oral doses of E2006 administered in the morning to healthy male and female subjects. Part B: The purpose of this study is to evaluate selected pharmacodynamic (PD) parameters (e.g., polysomnographically defined s...
What is the current status of trial NCT01463098?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 122 participants. The study started on 2011-10-05. Estimated completion is 2012-08-11.
What interventions are being tested in trial NCT01463098?
The interventions under investigation include: E2006 1.0 mg (DRUG), E2006 2.5 mg (DRUG), E2006 5.0 mg (DRUG), E2006 10.0 mg (DRUG), E2006 25.0 mg (DRUG).
Who is sponsoring clinical trial NCT01463098?
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 NCT01463098's enrollment target sits among peer trials
122 475th of 2000 higher than 1,525 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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