NCT01327872

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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%.

Detailed description

This is a Phase 2, multi-center, double-blind, randomized, placebo-controlled, dose-ranging, parallel-group study. The PK and PK/PD relationship of AKR-501 will also be studied. Approximately 65 eligible patients will be randomized in a 3:3:3:3:1 ratio in a double-blinded fashion into one of five parallel treatment groups to receive daily doses of either AKR-501 2.5, 5, 10 or 20 mg or placebo for 28 days, respectively. Each AKR-501 dosing group will consist of 15 patients while the placebo group will consist of 5 patients. All study patients will be evaluated weekly (Days 3, 5, 7, 14, 21 and 28) for safety, efficacy, and (Days 7, 14, 21, and 28) AKR-501 pharmacokinetics while receiving study treatment with a final assessment for safety and effectiveness to be done 2 weeks after the last study dose (Day 42).

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-04-01
• Completion: 2011-06-01
• First posted: 2011-04-04
• Last updated: 2012-03-09

Locations

1 site across 1 country: Netherlands