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NCT02207790 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2609 in Healthy Adult Male Japanese and White Subjects
A Phase 1 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT02207790 is a Phase 1 study that has completed, run by Eisai. The registered enrollment target is 32 participants.
The verdict
NCT02207790, a Phase 1 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This study is primarily designed to bridge the pharmacokinetics (PK) and safety data for E2609 between Japanese subjects and non-Japanese (ie, white) subjects. To bridge these PK characteristics, the proposed study includes a cohort of white subjects treated for comparison with the cohort of Japanese subjects treated at the same dose. This comparison serves as a key PK bridge in assessing ethnic factors that may contribute to differences in plasma concentrations. Pharmacokinetic assessments in the proposed study will include confirmation of dose proportionality in Japanese subjects. This study will also evaluate safety and tolerability in Japanese subjects.
Interventions
- DRUG Placebo
- DRUG E2609
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2014-07 |
| Est. Completion | 2014-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02207790
The ClinicalTrials.gov registry entry for NCT02207790 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 2 interventions - of which Placebo is the first listed.
NCT02207790 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02207790 about?
NCT02207790 is a clinical study titled "Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2609 in Healthy Adult Male Japanese and White Subjects". This study is primarily designed to bridge the pharmacokinetics (PK) and safety data for E2609 between Japanese subjects and non-Japanese (ie, white) subjects. To bridge these PK characteristics, the proposed study includes a cohort of white subjects treated for comparison with the cohort of Japanes...
What is the current status of trial NCT02207790?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2014-07. Estimated completion is 2014-10.
What interventions are being tested in trial NCT02207790?
The interventions under investigation include: Placebo (DRUG), E2609 (DRUG).
Who is sponsoring clinical trial NCT02207790?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
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