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Single and Multiple Dose Asian Bridging Study

NCT01251731 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2012-04-06

No results posted yet for this 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

  • Healthy Subjects

Interventions

DRUG

E5501

Treatment Group 1: 10mg E5501 as a single dose in Treatment Period 1, followed by a single dose of 40mg E5501 in Treatment Period 2, followed by a single dose of 80mg E5501 in Treatment Period 3, followed by a selected dose for the Multiple Dose reatment Period.

DRUG

E5501

Treatment Group 2: 40 mg E5501 as a single dose in Treatment Period 1, followed by a single dose of 80mg E5501 in Treatment Period 2, followed by a single dose of 10mg E5501 in Treatment Period 3, followed by a selected dose for the Multiple Dose Treatment Period.

DRUG

E5501

Treatment Group 3: 80mg E5501 as a single dose in Treatment Period 1, followed by a single dose of 10mg E5501 in Treatment Period 2, followed by a single dose of 40mg E5501 in Treatment Period 3, followed by a selected dose for the Multiple Dose Treatment Period.

DRUG

E5501

Treatment Group 4: A single dose of matching placebo in each of the three Single Dose Treatment Periods and in the Multiple Dose Treatment Period

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • Franklin Johnson · Eisai Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01251731 on ClinicalTrials.gov