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Your journey
1What's a trial
4Get in touch
More info
You can access this
clinical trial
if you have
Purpura, Thrombocytopenic, Idiopathic, Acute Idiopathic Thrombocytopenic Purpura or Chronic Thrombocytopenia
and you are
between 18 and 55
years old
This is an early phase trial to determine
the dosage and safety of the new treatment.
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The purpose

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%.

Provided treatments

  • Drug: E5501 40 mg 2 x 20-mg tablets, orally, fasted
  • Drug: E5501 40 mg 2 x 20-mg tablets, orally, with food
  • Drug: E5501 40mg 2 x 20-mg tablets, orally, fasted
  • Drug: E5501 40 mg 2 x 20-mg tablets, orally, with food

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01327872. The sponsor of the trial is Eisai Inc. and it is looking for 84 volunteers for the current phase.
Official trial title:
A Randomized, Open-Label, 4-Group, 2-Period Replicate Design Study to Evaluate Within- and Between-Subject Variability in Exposure of Two Lots of E5501 20 mg Tablets, Administered as Single Doses of 40 mg, in the Fasted and Fed Conditions to Healthy Subjects