NCT01549054

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

A Single-center, Randomized, Open-label, Two-part Study to Evaluate Bioavailability of Prototype Third-generation Formulations of E5501 Relative to Second-generation Tablet Formulation in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-06-01
• Completion: 2012-08-01
• First posted: 2012-03-08
• Last updated: 2013-11-01

Locations

1 site across 1 country: United Kingdom