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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 is a Phase 1 study that has completed, run by Eisai. The registered enrollment target is 122 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01463098
The ClinicalTrials.gov registry entry for NCT01463098 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 122 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 5 interventions - of which E2006 1.0 mg is the first listed.
NCT01463098 reports 0 study locations.
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.
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