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NCT01251731 · ClinicalTrials.gov registry record · Phase 1
Single and Multiple Dose Asian Bridging Study
A Phase 1 study of Healthy Subjects, sponsored by Eisai.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT01251731: Completed Phase 1 study of Healthy Subjects, sponsored by Eisai.
NCT01251731 is a Phase 1 study of Healthy Subjects that has completed, run by Eisai. The registered enrollment target is 36 participants, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01251731, a Phase 1 study of Healthy Subjects, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the single-dose (SD) pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of 10, 40, and 80 mg E5501 followed by a selected dose for multiple dosing (MD) in healthy Japanese, Chinese, and Caucasian subjects.
Conditions Studied
Interventions
- DRUG E5501
Study Locations (1)
California
- Parexel International, Early Phase Clinical Unit - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2010-07 |
| Phase | Phase 1 |
What the finished NCT01251731 record still lists
NCT01251731 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Healthy Subjects appearing as the primary indexed condition, and to 1 intervention - of which E5501 is the first listed.
NCT01251731 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01251731 about?
NCT01251731 is a clinical study titled "Single and Multiple Dose Asian Bridging Study". The purpose of this study is to evaluate the single-dose (SD) pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of 10, 40, and 80 mg E5501 followed by a selected dose for multiple dosing (MD) in healthy Japanese, Chinese, and Caucasian subjects.
What is the current status of trial NCT01251731?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2010-07.
What conditions does trial NCT01251731 study?
This clinical trial studies the following conditions: Healthy Subjects.
What interventions are being tested in trial NCT01251731?
The interventions under investigation include: E5501 (DRUG).
Who is sponsoring clinical trial NCT01251731?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01251731 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01251731's enrollment target sits among peer trials
36 32nd of 69 higher than 38 of 69 other Healthy Subjects trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Subjects 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.
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