An Study to Determine the Bioavailability of E2609 Tablet... | NCT01716897

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

NCT01716897

Sponsor

Eisai Inc.

Status

Completed

Last Update Posted

May 22, 2013Estimated

Enrollment

18Actual

Phase

Phase 1

Conditions

Alzheimer's Disease

Interventions

E2609

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Dec 2012Actual

Completion Date

Feb 2013Actual

First Submitted Date

Oct 23, 2012

First Submission Date that Met QC Criteria

Oct 29, 2012

First Posted Date

Oct 30, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 20, 2013

Last Update Posted Date

May 22, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
50 mg E2609 capsule formulation in fasted state	Other	50 mg E2609 capsule formulation	Drug: E2609
50 mg E2609 tablet formulation in fasted state	Other	50 mg E2609 tablet formulation in fasted state	Drug: E2609
50 mg tablet formulation in fed state	Other	50 mg E2609 tablet formulation in fed state	Drug: E2609

Interventions

Name	Type	Description	Arm Group Labels	Other Names
E2609	Drug		50 mg E2609 capsule formulation in fasted state 50 mg E2609 tablet formulation in fasted state 50 mg tablet formulation in fed state

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	Time Frame
incidence of Adverse events		5.5 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases