A Multiple Dose Pharmacokinetic Study of Perampanel in Korean Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Perampanel

• Registration Number: NCT02020486
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

This study will consist of 2 phases: Pretreatment Phase and Treatment Phase. The Pretreatment Phase will have 2 time points: Screening and Baseline. Subjects will be admitted to the clinical study ward the day before starting the study drug administration (Day -1) for PK and safety assessments during Treatment Phase, and discharged at Day 33 (group A) and Day 47 (group B). Post-test will be done at Day 37 (+/-1), Day 42 (+3) (group A) and Day 51 (+/-1), Day 56 (+3) (group B). Study medication will be administered with 240 mL of room temperature water

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-04
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-25
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-09
• Last Update Submitted: 2015-02-27
• Last Update Posted: 2015-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Perampanel	Experimental
Group B	Perampanel	Days 1-14: Multiple oral dose of 2 mg perampanel (one 2 mg tablet) Days 15-28: Multiple oral dose of 4 mg perampanel (two 2 mg tablets) Days 29-42: Multiple oral dose of 6 mg perampanel (three 2 mg tablets)

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) of perampanel in Korean healthy male subjects	Approximately 56 days	PK analysis will be performed on PK Analysis Set using plasma concentrations of perampanel. Plasma concentrations will be tabulated by nominal sampling time and summarized using summary statistics.

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of perampanel	Approximately 56 days	Safety will be assessed by monitoring and recording all adverse events (AEs) and serious adverse events (SAEs), regular monitoring of hematology, blood chemistry and urine values, regular measurement of vital signs, weight, physical examinations and electrocardiograms (ECGs).

Trial Locations

Locations (1)

Inje University Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of