MedTrace Logo

A Multiple Dose Pharmacokinetic Study of Perampanel in Korean Healthy Subjects

NCT02020486 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-03-03

No results posted yet for this study

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

DRUG

Perampanel

2 mg up to 4 mg

DRUG

Perampanel

2 mg up to 6 mg

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02020486 on ClinicalTrials.gov