An Open-Label, Single-Dose Study to Determine the Metabolism and Elimination of 14C-Perampanel in Healthy Male Subjects

Eisai Inc.7 enrolled

Overview

This is an open-label, single-dose study in healthy male subjects. The study will have 2 phases: Pretreatment and Treatment. The Pretreatment Phase will last up to 21 days and will consist of a Screening Period and a Baseline Period, during which each subject's study eligibility will be determined and baseline assessments will be conducted.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Subjects

Interventions

E2007DRUG

14C-labeled perampanel dissolved in ethanol and administered using a capsule formulation in a single dose, one day

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria 1. Healthy male 18 to 55 years, inclusive, at the time of informed consent 2. Body mass index (BMI) of 18 to 30 kg/m2, inclusive, at Screening 3. Must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must not be of childbearing potential or must be practicing highly effective contraception throughout the study period and for 90 days after study drug discontinuation. No sperm donation is allowed during the study period and for 90 days after study drug discontinuation. 4. Provide written informed consent 5. Willing and able to comply with all aspects of the protocol Exclusion Criteria 1. Participated in a 14C research study within the 6 months before Day-2. The total exposure from this and any previous study must be within the recommended levels considered safe (per 21 Code of Federal Regulations \[CFR\] 361.1) 2. Exposure to clinically significant radiation within 12 months before Day-2 3. Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical attention within 4 weeks of dosing

Locations (1)

Covance Clinical Research Unit Inc.

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

Mass balance recovery of 14C as a cumulative percent of the radiolabeled dose and the identification and quantification of metabolites in humans in vivo after administration of a single dose of radiolabeled 14C-perampanel in healthy male subjects.

These will be guided by analysis of 14C-perampanel, perampanel, and metabolites in the biological matrices.