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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: E2007

• Registration Number: NCT02116907
• Lead Sponsor: Eisai Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-14
• Study First Submitted QC: 2014-04-15
• Study First Posted: 2014-04-17
• Study Start: 2014-05
• Primary Completion: 2014-07
• Study Completion: 2014-09
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Perampanel	E2007	14C-labeled perampanel dissolved in ethanol and administered using a capsule formulation in a single dose, one day

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of total radioactivity and E2007: Maximum observed concentration (Cmax)	Approximately 14 Weeks
Pharmacokinetics of total radioactivity and E2007: AUC(0-24h)	Approximately 14 Weeks	Area under the concentration x time curve from time 0 to 24 hours
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.	Approximately 14 Weeks	These will be guided by analysis of 14C-perampanel, perampanel, and metabolites in the biological matrices.
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-inf)	Approximately 14 Weeks	Area under the concentration x time curve from time 0 to infinity
Pharmacokinetics of total radioactivity and E2007: AUC(0-t)	Approximately 14 Weeks	Area under the concentration x time curve from time 0 to time of last measurable concentration
Pharmacokinetics of total radioactivity and E2007: terminal elimination half-life (t1/2)	Approximately 14 Weeks

Trial Locations

Locations (1)

Covance Clinical Research Unit Inc.; 🇺🇸 Madison, Wisconsin, United States