A Study to Demonstrate Bioequivalence Between 6 x 2 mg Tablets of Perampanel and a Single 12 mg Tablet of Perampanel in Healthy Subjects

NCT01240187 | Completed Phase 1

• 1 other identifier: E2007-E044-037
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the bioequivalence between 6 x 2 mg tablets and one 12 mg tablet of perampanel in healthy subjects.

Conditions

Partial Onset Epilepsy

Keywords

epilepsy

Outcome Measures

Primary Outcomes (1)

• To evaluate and compare the pharmacokinetic (PK) profile, safety, and tolerability of 6 x 2-mg tablets of perampanel with a single 12-mg tablet.

  12 weeks

Study Arms (2)

Experimental 1

EXPERIMENTAL

Drug: perampanel

Experimental 2

EXPERIMENTAL

Drug: perampanel

Interventions

perampanel DRUG

Single dose of 6 tablets 2 mg orally

Experimental 1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subjects aged between 18-55 years.
• BMI of 18-32 kg/m \^2.
• Willing and able to provide written informed consent.

You may not qualify if:

• Subjects taking prescribed or over the counter (OTC) medications in 2 weeks prior to screening.
• Subjects on special diets or dietary aids known to modulate drug metabolizing enzymes.
• Subjects who have taken inhibitor of CYP450 within 2 weeks of first dose.
• Subjects who have received any experimental drug in the 12 weeks prior to study drug treatment.
• Subjects with a history of alcohol abuse or who drink more than the recommended number of alcohol units per week.
• Subjects who consume more than five caffeinated beverages per day.
• Subjects who smoke more than 5 cigarettes per day.
• Subjects with a history of drug abuse or who have a positive urine drug screening test.
• Women who do not agree to use two methods of contraception.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

Quotient Clinical

Edinburgh, United Kingdom

Location

MeSH Terms

Conditions

Epilepsy

Interventions

perampanel

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Dr Joanne Collier

  Quotient Clinical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2010
• First Posted: November 15, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: May 14, 2013

Record last verified: 2011-05

Locations

GB (1)