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

Eisai

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: E2007

Study type: Interventional

Funder types: Industry

Identifiers

NCT02116907

2010-018518-56 (EudraCT Number)

E2007-A001-049

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Perampanel

Experimental group

Description:

14C-labeled perampanel dissolved in ethanol and administered using a capsule formulation in a single dose, one day

Treatment:

Drug: E2007