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

Study Overview
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Brief Summary
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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.

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: E2007


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Healthy male 18 to 55 years, inclusive, at the time of informed consent Body mass index (BMI) of 18 to 30 kg/m2, inclusive, at Screening 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. Provide written informed consent Willing and able to comply with all aspects of the protocol Exclusion Criteria 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) Exposure to clinically significant radiation within 12 months before Day-2 Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical attention within 4 weeks of dosing

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Perampanel<br>14C-labeled perampanel dissolved in ethanol and administered using a capsule formulation in a single dose, one day | Drug: E2007<br>* 14C-labeled perampanel dissolved in ethanol and administered using a capsule formulation in a single dose, one day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Approximately 14 Weeks | 
| Pharmacokinetics of total radioactivity and E2007: Maximum observed concentration (Cmax) |  | Approximately 14 Weeks | 
| Pharmacokinetics of total radioactivity and E2007: time to reach maximum (peak) concentration following drug administration (tmax) |  | Approximately 14 Weeks | 
| Pharmacokinetics of total radioactivity and E2007: AUC(0-24h) | Area under the concentration x time curve from time 0 to 24 hours | Approximately 14 Weeks | 
| Pharmacokinetics of total radioactivity and E2007: AUC(0-t) | Area under the concentration x time curve from time 0 to time of last measurable concentration | Approximately 14 Weeks | 
| Pharmacokinetics of total radioactivity and E2007: AUC(0-inf) | Area under the concentration x time curve from time 0 to infinity | Approximately 14 Weeks | 
| Pharmacokinetics of total radioactivity and E2007: terminal elimination half-life (t1/2) |  | Approximately 14 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy, Male Subjects