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NCT02039089 · ClinicalTrials.gov registry record · Phase 1
A Two-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006 in Healthy Japanese and White Subjects
A Phase 1 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT02039089 is a Phase 1 study that has completed, run by Eisai. The registered enrollment target is 32 participants.
The verdict
NCT02039089, a Phase 1 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This study will be a single-center, multiple-dose, randomized, double-blind, placebo-controlled, parallel-group study in healthy male and female subjects. The study will consist of 2 parts: Part A (3 cohorts of healthy Japanese subjects dosed in the evening) and Part B (one cohort of healthy white subjects dosed in the evening). The cohorts will be conducted sequentially. Part A will be started first with the 2.5-mg dose cohort, followed by the 10-mg dose cohort and then the 25-mg dose cohort. Part B will be conducted in parallel with the 10-mg cohort of Part A, with the possibility of overlap.
Interventions
- DRUG Placebo
- DRUG E2006 2.5 mg
- DRUG E2006 10 mg
- DRUG E2006 25 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2014-01 |
| Est. Completion | 2014-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02039089
The ClinicalTrials.gov registry entry for NCT02039089 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 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 4 interventions - of which Placebo is the first listed.
NCT02039089 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02039089 about?
NCT02039089 is a clinical study titled "A Two-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2006 in Healthy Japanese and White Subjects". This study will be a single-center, multiple-dose, randomized, double-blind, placebo-controlled, parallel-group study in healthy male and female subjects. The study will consist of 2 parts: Part A (3 cohorts of healthy Japanese subjects dosed in the evening) and Part B (one cohort of healthy white s...
What is the current status of trial NCT02039089?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2014-01. Estimated completion is 2014-05.
What interventions are being tested in trial NCT02039089?
The interventions under investigation include: Placebo (DRUG), E2006 2.5 mg (DRUG), E2006 10 mg (DRUG), E2006 25 mg (DRUG).
Who is sponsoring clinical trial NCT02039089?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
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