Open-Label Study of Bioavailability of E2006 Tablet Versu... | NCT01673880

Studies
Open-Label Study of Bioavailability of E2006 Tablet Versus Capsule Formulations

NCT01673880

Sponsor

Eisai Inc.

Status

Completed

Last Update Posted

May 22, 2013Estimated

Enrollment

40Actual

Phase

Phase 1

Conditions

Insomnia

Interventions

E2006

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

Mar 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

Aug 2012

Primary Completion Date

Oct 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Aug 22, 2012

First Submission Date that Met QC Criteria

Aug 27, 2012

First Posted Date

Aug 28, 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

Description Module

Brief Summary

This is a single-center, open-label, randomized crossover study being conducted in three cohorts of healthy adult subjects. Approximately 36 subjects will be randomized to one of three cohorts (approximately 12 subjects per cohort) and they will receive both a single dose of E2006 in capsule formulation and a single dose of E2006 in tablet formulation, in random sequence, at a 1:1 ratio. The doses to be tested will be 2.5 mg, 10 mg, and 25 mg.

Detailed Description

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

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
E2006 2.5 mg	Other	Drug: E2006
E2006 10mg	Other	Drug: E2006
E2006 25 mg	Other	Drug: E2006

Interventions

Name	Type	Description	Arm Group Labels	Other Names
E2006	Drug	2.5 mg, 10 mg, and 25 mg E2006 tablets	E2006 10mg E2006 2.5 mg E2006 25 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Plasma concentrations of E2006 of tablet vs. capsule formulations		up to 336 hours post-dose

Secondary Outcomes

Measure	Description	Time Frame
Incidence of adverse events (AEs)		36 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion:

Healthy males or females,
ages 18 to 55 years
Body mass index (BMI) >
18 and 32 kg/m2 at Screening

Exclusion:

Female subjects who are nursing
Subjects with a history of gastrointestinal surgery (hepatectomy, nephrectomy, digestive organ resection, etc.) that may affect PK profiles of E2006
Subjects with a known history of clinically significant drug or food allergies
Subjects with a known allergy or hypersensitivity to capsule or tablet ingredients

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aziz Laurent	PPD Development, LP	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PPD Development, LLC		Austin	Texas	78704	United States

Condition Browse Module

MeSH Terms

ID	Term
D007319	Sleep Initiation and Maintenance Disorders

Ancestor Terms

ID	Term
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided