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

Primary Purpose

Alzheimer's Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

E2609

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

30 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria

Caucasian males defined as persons of a European or Latin American descent
Healthy male 30 to 55 years inclusive at the time of informed consent
Body mass index (BMI) of 18 to 32 kg/m2 at Screening
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

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
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
Any history of cerebrovascular disease (stroke or transient ischemic attack)
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
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
Hypersensitivity to the study drugs or any of their excipients

Sites / Locations

California Clinical Trials/Parexel

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

50 mg E2609 capsule formulation in fasted state

50 mg E2609 tablet formulation in fasted state

50 mg tablet formulation in fed state

Arm Description

50 mg E2609 capsule formulation

50 mg E2609 tablet formulation in fasted state

50 mg E2609 tablet formulation in fed state

Outcomes

Primary Outcome Measures

AUC(0-inf) ratio, new tablet vs. capsule

AUC(0-inf) ratio, fed state vs. fasted state, both after administration of new tablet

Cmax ratio, new tablet vs. capsule

Cmax ratio, fed state vs. fasted state, both after administration of new tablet

Secondary Outcome Measures

incidence of Adverse events

Full Information

NCT ID

NCT01716897

First Posted

October 23, 2012

Last Updated

May 20, 2013

Sponsor

Eisai Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01716897

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eisai Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

50 mg E2609 capsule formulation in fasted state

Arm Type

Other

Arm Description

50 mg E2609 capsule formulation

Arm Title

50 mg E2609 tablet formulation in fasted state

Arm Type

Other

Arm Description

50 mg E2609 tablet formulation in fasted state

Arm Title

50 mg tablet formulation in fed state

Arm Type

Other

Arm Description

50 mg E2609 tablet formulation in fed state

Intervention Type

Drug

Intervention Name(s)

E2609

Primary Outcome Measure Information:

Title

AUC(0-inf) ratio, new tablet vs. capsule

Time Frame

0 -144 hours

Title

AUC(0-inf) ratio, fed state vs. fasted state, both after administration of new tablet

Time Frame

0 - 144 hours

Title

Cmax ratio, new tablet vs. capsule

Time Frame

0 - 144 hours

Title

Cmax ratio, fed state vs. fasted state, both after administration of new tablet

Time Frame

0 - 144 hours

Secondary Outcome Measure Information:

Title

incidence of Adverse events

Time Frame

5.5 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Caucasian males defined as persons of a European or Latin American descent Healthy male 30 to 55 years inclusive at the time of informed consent Body mass index (BMI) of 18 to 32 kg/m2 at Screening 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 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 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 Any history of cerebrovascular disease (stroke or transient ischemic attack) 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 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 Hypersensitivity to the study drugs or any of their excipients

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Haykop Gevorkyan

Organizational Affiliation

California Clinical Trials Medical Group/Parexel

Official's Role

Principal Investigator

Facility Information:

Facility Name

California Clinical Trials/Parexel

City

Glendale

State/Province

California

ZIP/Postal Code

91206

Country

United States

12. IPD Sharing Statement

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

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