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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:4/21/2016
Start Date:May 2014
End Date:September 2014

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Trial Summary
Trial Overview
Inclusion Criteria

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.


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
We found this trial at
1
site
Covance Clinical Research Unit
Madison, Wisconsin 53718
?
mi
from
Madison, WI
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