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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: Completed Phase 1 study, sponsored by Eisai.
NCT02039089 is a Phase 1 study that has completed, run by Eisai. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary PK parameters are Cmax, tmax, AUC(0-T), AUC(0-24h), and t1/2, derived by non-compartmental analyses using the plasma concentration of E2006 and metabolites (as data permit).
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 |
What the finished NCT02039089 record still lists
NCT02039089 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02039089 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02039089's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 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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