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

Healthy Subjects Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02116907
• Other study ID #: E2007-A001-049
• Secondary ID: 2010-018518-56
• Status: Completed
• Phase: Phase 1
• First received: April 14, 2014
• Last updated: November 2, 2015
• Start date: May 2014
• Est. completion date: September 2014

Study information

• Verified date: November 2015
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: September 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• E2007
14C-labeled perampanel dissolved in ethanol and administered using a capsule formulation in a single dose, one day

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit Inc.	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	These will be guided by analysis of 14C-perampanel, perampanel, and metabolites in the biological matrices.	Approximately 14 Weeks	No
Primary	Pharmacokinetics of total radioactivity and E2007: Maximum observed concentration (Cmax)		Approximately 14 Weeks	No
Primary	Pharmacokinetics of total radioactivity and E2007: time to reach maximum (peak) concentration following drug administration (tmax)		Approximately 14 Weeks	No
Primary	Pharmacokinetics of total radioactivity and E2007: AUC(0-24h)	Area under the concentration x time curve from time 0 to 24 hours	Approximately 14 Weeks	No
Primary	Pharmacokinetics of total radioactivity and E2007: AUC(0-t)	Area under the concentration x time curve from time 0 to time of last measurable concentration	Approximately 14 Weeks	No
Primary	Pharmacokinetics of total radioactivity and E2007: AUC(0-inf)	Area under the concentration x time curve from time 0 to infinity	Approximately 14 Weeks	No
Primary	Pharmacokinetics of total radioactivity and E2007: terminal elimination half-life (t1/2)		Approximately 14 Weeks	No