A Study to Demonstrate Bioequivalence Between 6 x 2 mg Ta... | NCT01240187

Studies
A Study to Demonstrate Bioequivalence Between 6 x 2 mg Tablets of Perampanel and a Single 12 mg Tablet of Perampanel in Healthy Subjects

NCT01240187

Sponsor

Eisai Inc.

Status

Completed

Last Update Posted

May 14, 2013Estimated

Enrollment

22Actual

Phase

Phase 1

Conditions

Partial Onset Epilepsy

Interventions

perampanel
perampanel

Countries

United Kingdom

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

May 2011

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

Jun 2010

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Sep 23, 2010

First Submission Date that Met QC Criteria

Nov 10, 2010

First Posted Date

Nov 15, 2010Estimated

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 13, 2013

Last Update Posted Date

May 14, 2013Estimated

Description Module

Brief Summary

The purpose of this study is to investigate the bioequivalence between 6 x 2 mg tablets and one 12 mg tablet of perampanel in healthy subjects.

Detailed Description

A Single Centre, open label, 2-period, 2-sequence crossover bioequivalence study in one group of 28 subjects.

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

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental 1	Experimental		Drug: perampanel
Experimental 2	Experimental		Drug: perampanel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
perampanel	Drug	Single dose of 6 tablets 2 mg orally	Experimental 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate and compare the pharmacokinetic (PK) profile, safety, and tolerability of 6 x 2-mg tablets of perampanel with a single 12-mg tablet.		12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male or female subjects aged between 18-55 years.
BMI of 18-32 kg/m ^2.
Willing and able to provide written informed consent.

Exclusion criteria:

Subjects taking prescribed or over the counter (OTC) medications in 2 weeks prior to screening.
Subjects on special diets or dietary aids known to modulate drug metabolizing enzymes.
Subjects who have taken inhibitor of CYP450 within 2 weeks of first dose.
Subjects who have received any experimental drug in the 12 weeks prior to study drug treatment.
Subjects with a history of alcohol abuse or who drink more than the recommended number of alcohol units per week.
Subjects who consume more than five caffeinated beverages per day.
Subjects who smoke more than 5 cigarettes per day.
Subjects with a history of drug abuse or who have a positive urine drug screening test.
Women who do not agree to use two methods of contraception.

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
Dr Joanne Collier	Quotient Clinical	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Quotient Clinical		Edinburgh			United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C551441	perampanel

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided