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Subject Variability in Two Lots of E5501 Administered to Fed and Fasted Healthy Subjects

NCT01327872 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2012-03-09

No results posted yet for this study

Summary

This will be a randomized, open-label, four-group, two-period, replicate design study to evaluate the effect of food on within and between subject variability in second generation formulation 20-mg tablet strengths, Lots P01008ZZA and P01009ZZA, administered as single doses of 40mg to 84 healthy male and female subjects. The study is powered to detect both a reduction in either the within or between subject variability (coefficient of variation \[CV\]%) of approximately 35%.

Conditions

  • Purpura, Thrombocytopenic, Idiopathic
  • Acute Idiopathic Thrombocytopenic Purpura
  • Chronic Thrombocytopenia

Interventions

DRUG

E5501 40 mg 2 x 20-mg tablets, orally, fasted

single 40 mg dose (2 x 20-mg tablets) of Lot P01008ZZA in the fasted condition

DRUG

E5501 40 mg 2 x 20-mg tablets, orally, with food

single 40 mg dose (2 x 20-mg tablets) of Lot P01008ZZA in the fed condition

DRUG

E5501 40mg 2 x 20-mg tablets, orally, fasted

single 40 mg dose (2 x 20-mg tablets) of Lot P01009ZZA in the fasted condition

DRUG

E5501 40 mg 2 x 20-mg tablets, orally, with food

single 40 mg dose (2 x 20-mg tablets) of Lot P01009ZZA in the fed condition

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • Franklin Johnson · Eisai Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-04-30
Completion
2011-06-30

Countries

  • Netherlands

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 NCT01327872 on ClinicalTrials.gov