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Completed

NCT Number: NCT02116907

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

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.

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Key information

Conditions

Healthy Subjects

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit Inc.

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

E2007

Drug

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

Primary outcomes

  1. 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.

    Time frame: Approximately 14 Weeks

    These will be guided by analysis of 14C-perampanel, perampanel, and metabolites in the biological matrices.

  2. Pharmacokinetics of total radioactivity and E2007: Maximum observed concentration (Cmax)

    Time frame: Approximately 14 Weeks

  3. Pharmacokinetics of total radioactivity and E2007: time to reach maximum (peak) concentration following drug administration (tmax)

    Time frame: Approximately 14 Weeks

  4. Pharmacokinetics of total radioactivity and E2007: AUC(0-24h)

    Time frame: Approximately 14 Weeks

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

  5. Pharmacokinetics of total radioactivity and E2007: AUC(0-t)

    Time frame: Approximately 14 Weeks

    Area under the concentration x time curve from time 0 to time of last measurable concentration

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

    Time frame: Approximately 14 Weeks

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

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

    Time frame: Approximately 14 Weeks

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 17, 2014
Registry last updated
Nov 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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