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A Study in Healthy Subjects to Evaluate Bioavailability of 4 Formulations of E5501

NCT01549054 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2013-11-01

No results posted yet for this study

Summary

This is a study in healthy subjects. There are two parts to the study. In the first part of the study each subject will receive a single 10mg dose of each of the four formulations of E550. Based on the results from Part 1, an optimal formulation will be selected for further evaluation in Part 2.

Conditions

  • Idiopathic Thrombocytopenic Purpura

Interventions

DRUG

10-mg dose of E5501 2G tablet

Treatment A: Single 10-mg dose of E5501 2G tablet

DRUG

10-mg dose of E5501 cyclodextrin oral solution

Treatment B: Single 10-mg dose of E5501 cyclodextrin oral solution

DRUG

10-mg dose of E5501-P21% powder

Treatment C: Single 10-mg dose of E5501-P21% powder oral suspension

DRUG

10-mg dose of E5501 lipid-based oral

Treatment D: Single 10-mg dose of E5501 lipid-based oral suspension

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • Bhaskar Rege · Eisai Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-06-30
Completion
2012-08-31

Countries

  • United Kingdom

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 NCT01549054 on ClinicalTrials.gov