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

A Randomized, Open-label, 3-treatment Crossover Study to Determine the Bioavailability of E2609 Tablets Compared to Capsules and the Effect of Food on Absorption in Healthy Caucasian Male Adults

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: E2609

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • California Clinical Trials/Parexel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria

1. Caucasian males defined as persons of a European or Latin American descent
2. Healthy male 30 to 55 years inclusive at the time of informed consent
3. Body mass index (BMI) of 18 to 32 kg/m2 at Screening
4. Subjects must have had a successful vasectomy (confirmed azoospermia), or they and their female partners must not be of childbearing potential or must be practicing highly effective contraception throughout the study period and for 30 days after study drug discontinuation. No sperm donation is allowed during the study period and for 30 days after study drug discontinuation.

Exclusion Criteria

1. Any history of seizures or epilepsy (not including a history of simple febrile seizures in childhood) or disturbance of consciousness likely to be due to seizures
2. Any medical condition which, in the opinion of the investigator has high risk of seizures (e.g., history of traumatic brain injury associated with loss of consciousness or amnesia, alcohol abuse, substance abuse) at Screening or within past 5 years
3. Any history of cerebrovascular disease (stroke or transient ischemic attack)
4. A history of prolonged QT/QTc interval or prolonged period from the beginning of the QRS complex to the end of the T wave on an ECG (QT)/ QT corrected for heart rate using Fridericia?s formula (QTcF) interval (QTcF > 450 ms) as demonstrated by the mean of triplicate electrocardiogram (ECGs) (recorded at least 1 min apart) at Screening or Baseline Period
5. Any other clinically significant ECG abnormalities at Screening or Baseline Periods, e.g. component of the ECG cycle from onset of atrial depolarization to onset of ventricular depolarization (PR)>220 ms, component of ECG wave representing ventricular depolarization (QRS)>110 ms
6. Hypersensitivity to the study drugs or any of their excipients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 50 mg E2609 capsule formulation in fasted state; 50 mg E2609 capsule formulation	Drug: E2609
OTHER: 50 mg E2609 tablet formulation in fasted state	Drug: E2609
OTHER: 50 mg tablet formulation in fed state; 50 mg E2609 tablet formulation in fed state	Drug: E2609

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
incidence of Adverse events	5.5 weeks

Collaborators and Investigators

• Sponsor: Eisai Inc.
• Investigators: Principal Investigator: Haykop Gevorkyan, California Clinical trials medical group/PAREXEL

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): February 1, 2013

Study Registration Dates

• First Submitted: October 23, 2012
• First Submitted That Met QC Criteria: October 29, 2012
• First Posted (ESTIMATE): October 30, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): May 22, 2013
• Last Update Submitted That Met QC Criteria: May 20, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: E2609-A001-007