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

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 Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: E2007

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Covance Clinical Research Unit Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Perampanel; 14C-labeled perampanel dissolved in ethanol and administered using a capsule formulation in a single dose, one day	Drug: E2007; 14C-labeled perampanel dissolved in ethanol and administered using a capsule formulation in a single dose, one day

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Eisai Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (ACTUAL): July 1, 2014
• Study Completion (ACTUAL): September 1, 2014

Study Registration Dates

• First Submitted: April 14, 2014
• First Submitted That Met QC Criteria: April 15, 2014
• First Posted (ESTIMATE): April 17, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): November 3, 2015
• Last Update Submitted That Met QC Criteria: November 2, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Healthy; Male Subjects
• Other Study ID Numbers: E2007-A001-049; 2010-018518-56 (EUDRACT_NUMBER)