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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 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.

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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

FieldValue
Enrollment Target 36 participants
Start Date 2010-07
Phase Phase 1

Sponsor

Eisai

287 total trials

What the Registry Record Tells You About NCT01251731

The ClinicalTrials.gov registry entry for NCT01251731 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 128-participant average among 69 other Healthy Subjects trials with a reported enrollment target (72% lower). The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.