An Study to Determine the Bioavailability of E2609 Tablets Compared to Capsules and the Effect of Food on Absorption

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: E2609

• Registration Number: NCT01716897
• Lead Sponsor: Eisai Inc.

Brief Summary

This study will be a single-center, open-label, randomized, 3-treatment crossover study of single oral doses of an API-capsule formulation of E2609 under fasted conditions and a tablet formulation administered under fed and fasted conditions in healthy subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-23
• Study First Submitted QC: 2012-10-29
• Study First Posted: 2012-10-30
• Primary Completion: 2012-12
• Status Verified: 2013-02
• Study Completion: 2013-02
• Last Update Submitted: 2013-05-20
• Last Update Posted: 2013-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
50 mg E2609 capsule formulation in fasted state	E2609	50 mg E2609 capsule formulation
50 mg E2609 tablet formulation in fasted state	E2609	50 mg E2609 tablet formulation in fasted state
50 mg tablet formulation in fed state	E2609	50 mg E2609 tablet formulation in fed state

Primary Outcome Measures

Name	Time	Method
AUC(0-inf) ratio, new tablet vs. capsule	0 -144 hours
AUC(0-inf) ratio, fed state vs. fasted state, both after administration of new tablet	0 - 144 hours
Cmax ratio, new tablet vs. capsule	0 - 144 hours
Cmax ratio, fed state vs. fasted state, both after administration of new tablet	0 - 144 hours

Secondary Outcome Measures

Name	Time	Method
incidence of Adverse events	5.5 weeks

Trial Locations

Locations (1)

California Clinical Trials/Parexel; 🇺🇸 Glendale, California, United States