An Open-Label, Single-Dose Study to Determine the Metabolism and Elimination of 14C-Perampanel in Healthy Male Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Eisai Inc.
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics of total radioactivity and E2007: Maximum observed concentration (Cmax)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Perampanel
14C-labeled perampanel dissolved in ethanol and administered using a capsule formulation in a single dose, one day
Intervention: E2007 (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics of total radioactivity and E2007: Maximum observed concentration (Cmax)
Time Frame: Approximately 14 Weeks
Pharmacokinetics of total radioactivity and E2007: AUC(0-24h)
Time Frame: 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.
Time Frame: 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)
Time Frame: Approximately 14 Weeks
Pharmacokinetics of total radioactivity and E2007: AUC(0-inf)
Time Frame: Approximately 14 Weeks
Area under the concentration x time curve from time 0 to infinity
Pharmacokinetics of total radioactivity and E2007: AUC(0-t)
Time Frame: 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)
Time Frame: Approximately 14 Weeks
Secondary Outcomes
No secondary outcomes reported