Healthy Subjects
Conditions
Keywords
Healthy, Male Subjects
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.
Interventions
DRUGE2007
14C-labeled perampanel dissolved in ethanol and administered using a capsule formulation in a single dose, one day
Sponsors
Eisai Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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: 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) | Approximately 14 Weeks | Area under the concentration x time curve from time 0 to 24 hours |
| 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: AUC(0-inf) | Approximately 14 Weeks | Area under the concentration x time curve from time 0 to infinity |
| Pharmacokinetics of total radioactivity and E2007: terminal elimination half-life (t1/2) | Approximately 14 Weeks | — |
Countries
United States
Outcome results
None listed