Clinical trial NCT02116907: An Open-Label, Single-Dose Study to Determine the Metabolism and Elimination of 14C-Perampanel in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Healthy
Male Subjects
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-17
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Approximately 14 Weeks
measure: Pharmacokinetics of total radioactivity and E2007: Maximum observed concentration (Cmax)
timeFrame: Approximately 14 Weeks
measure: Pharmacokinetics of total radioactivity and E2007: time to reach maximum (peak) concentration following drug administration (tmax)
timeFrame: Approximately 14 Weeks
measure: Pharmacokinetics of total radioactivity and E2007: AUC(0-24h)
timeFrame: Approximately 14 Weeks
measure: Pharmacokinetics of total radioactivity and E2007: AUC(0-t)
timeFrame: Approximately 14 Weeks
measure: Pharmacokinetics of total radioactivity and E2007: AUC(0-inf)
timeFrame: Approximately 14 Weeks
measure: Pharmacokinetics of total radioactivity and E2007: terminal elimination half-life (t1/2)
timeFrame: Approximately 14 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Clinical Research Unit Inc.
state: Wisconsin
Study officials:
References: