Bioequivalence Study Between a 4-mg Dose of Fine Granules... | NCT03399734

Studies
Bioequivalence Study Between a 4-mg Dose of Fine Granules of Perampanel and a 4-mg Tablet of Perampanel in Healthy Japanese Subjects

NCT03399734

Sponsor

Eisai Co., Ltd.

Status

Completed

Last Update Posted

Oct 29, 2018Actual

Enrollment

24Actual

Phase

Phase 1

Conditions

Healthy Participants

Interventions

Perampanel
Perampanel

Countries

Japan

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

Jan 2018

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

Dec 18, 2017Actual

Primary Completion Date

Mar 9, 2018Actual

Completion Date

Mar 9, 2018Actual

First Submitted Date

Jan 8, 2018

First Submission Date that Met QC Criteria

Jan 9, 2018

First Posted Date

Jan 16, 2018Actual

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

Oct 26, 2018

Last Update Posted Date

Oct 29, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

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

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment A	Experimental	4 milligrams (mg) perampanel tablet	Drug: Perampanel
Treatment B	Experimental	4 mg perampanel fine granules	Drug: Perampanel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Perampanel	Drug	Single oral dose of 1 x 4-mg perampanel tablet	Treatment A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum observed concentration (Cmax)		0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Area under the concentration-time curve from zero time to 168 hours (AUC[0-168h])		0-168 hours postdose of Treatment Period 1 and Treatment Period 2

Secondary Outcomes

Measure	Description	Time Frame
Time at which the highest drug concentration occurs (tmax)		0-168 hours postdose of Treatment Period 1 and Treatment Period 2
Lag time (tlag)	tlag is the time delay between drug administration and the onset of drug absorption.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Participants must meet all of the following criteria to be included in this study:

Non-smoking, male or female age ≥20 years and ≤45 years old at the time of obtaining written informed consent. To be considered non-smokers, participants must have discontinued smoking from Screening before first dosing.
Body Mass Index ≥18.5 and <25.0 kilograms per meters squared at Screening

Exclusion Criteria

Participants who meet any of the following criteria will be excluded from this study:

Females who are breastfeeding or pregnant at Screening or Baseline
Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks before first dosing
Evidence of disease that may influence the outcome of the study within 4 weeks before first dosing
Any history of gastrointestinal surgery that may affect pharmacokinetic profiles of perampanel at Screening
Any clinically abnormal symptom or organ impairment found by medical history at Screening, and physical examinations, vital signs, electrocardiogram (ECG) finding, or laboratory test results that require medical treatment at Screening
A prolonged QT/QT corrected interval (QT interval, Fridericia correction >450 milliseconds) as demonstrated by a repeated ECG at Screening or Baseline

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided