A Study to Demonstrate Bioequivalence Between a 12-mg Dose of an Oral Suspension Formulation of Perampanel and a 12-mg Tablet Formulation of Perampanel Under Fasted and Fed Conditions in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: Perampanel

• Registration Number: NCT02279485
• Lead Sponsor: Eisai Inc.

Brief Summary

This is an open-label, 2-arm, single-dose, randomized crossover study. The study will enroll a total of 100 subjects (2 arms with 50 subjects in each arm). In Arm 1, bioequivalence between the oral suspension and tablet formulations of perampanel will be evaluated under fasted conditions; in Arm 2, bioequivalence between the oral suspension and tablet formulations will be evaluated under fed conditions. In both study arms, subjects will be randomized on Study Day 1 for Treatment Period 1 to receive a single 12-mg dose for perampanel as either oral suspension or a tablet, and will then receive the alternative treatment on Study Day 43 of Treatment Period 2. Drug administration will be separated by a washout of at least 6 weeks between the two treatment periods.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-10-15
• Study First Submitted QC: 2014-10-29
• Study First Posted: 2014-10-31
• Primary Completion: 2014-12
• Study Completion: 2015-01
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Perampanel - Group 1	Perampanel	Treatment A: Single oral dose of a 12-mg perampanel tablet under fasted condition. Treatment B: Single 12 mg dose of perampanel oral suspension under fasted condition. Subjects will be randomized on Study Day 1 for Treatment Period 1 to Treatment A or Treatment B. On Study Day 43 the subject will then receive the alternate Treatment for Treatment Period 2.
Perampanel - Group 2	Perampanel	Treatment C: Single oral dose of a 12-mg perampanel tablet co-administered with high fat meal. Treatment D: Single 12 mg dose of perampanel oral suspension co-administered with high fat meal. Subjects will be randomized on Study Day 1 for Treatment Period 1 to Treatment C or Treatment D. On Study Day 43 the subject will then receive the alternate Treatment for Treatment Period 2.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of Perampanel: AUC(0-t)	Up to 504 hours postdose in each treatment period
Pharmacokinetics of Perampanel: AUC(0-inf)	Up to 504 hours postdose in each treatment period
Pharmacokinetics of Perampanel: Cmax	Up to 504 hours postdose in each treatment period

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of Perampanel: AUC(0-72h)	Up to 504 hours postdose in each treatment period
Pharmacokinetics of Perampanel: tmax	Up to 504 hours postdose in each treatment period
Pharmacokinetics of Perampanel: tlag	Up to 504 hours postdose in each treatment period
Pharmacokinetics of Perampanel: Lambda-z	Up to 504 hours postdose in each treatment period
Pharmacokinetics of Perampanel: t1/2	Up to 504 hours postdose in each treatment period