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

NCT02116907 | Completed Phase 1

• 2 other identifiers: E2007-A001-0492010-018518-56
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Keywords

Healthy; Male Subjects

Outcome Measures

Primary Outcomes (7)

• 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

• 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)

  Area under the concentration x time curve from time 0 to 24 hours

  Approximately 14 Weeks

• 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

• Pharmacokinetics of total radioactivity and E2007: AUC(0-inf)

  Area under the concentration x time curve from time 0 to infinity

  Approximately 14 Weeks

• Pharmacokinetics of total radioactivity and E2007: terminal elimination half-life (t1/2)

  Approximately 14 Weeks

Study Arms (1)

Perampanel

EXPERIMENTAL

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

Drug: E2007

Interventions

E2007 DRUG

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

Perampanel

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male 18 to 55 years, inclusive, at the time of informed consent
• Body mass index (BMI) of 18 to 30 kg/m2, inclusive, at Screening
• 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.
• Provide written informed consent
• Willing and able to comply with all aspects of the protocol

You may not qualify if:

• 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)
• Exposure to clinically significant radiation within 12 months before Day-2
• Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical attention within 4 weeks of dosing

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

Covance Clinical Research Unit Inc.

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

perampanel

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: April 17, 2014
• Study Start: May 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 3, 2015

Record last verified: 2015-11

Locations

US (1)