NCT02020486

A Multiple Dose Pharmacokinetic Study of Perampanel in Korean Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: Male
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Perampanel	2 mg up to 4 mg
DRUG	Perampanel	2 mg up to 6 mg

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2013-12-25
• Last updated: 2015-03-03

Locations

1 site across 1 country: South Korea