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Completed

NCT Number: NCT03444818

A Study to Determine the Absorption, Metabolism, and Excretion of [14C]-E6007 After a Single Oral Administration in Healthy Male Participants

This study will be conducted to evaluate the absorption, metabolism, and excretion of a single oral dose of [14C]-E6007 in healthy male participants.

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Key information

Age range

30 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit (CRU) Ltd.

Leeds, West Yorkshire, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 30 to 55 years of age
  • Body mass index between 18.5 and 30.0 kilograms per meters squared (kg/m^2), and a total body weight between 50 and 100 kilograms (kg)
  • In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead electrocardiogram, vital sign measurements, and clinical laboratory evaluations
  • Males will agree to use contraception
  • Able to comprehend and willing to sign an informed consent form and to abide by the study restrictions

Exclusion criteria

  • Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
  • History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
  • History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, and hernia repair will be allowed)
  • Significant history or clinical manifestation of hemorrhoids
  • History of alcoholism or drug/chemical abuse within 2 years prior to Check-in
  • Positive hepatitis panel and/or positive human immunodeficiency virus test
  • Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to Check-in
  • Use or intend to use any prescription medications/products within 14 days prior to Check-in
  • Participants in receipt of a live vaccine within 30 days prior to the first dose administration or who plan to receive a live vaccine during the study and for 14 days after the dose of study drug
  • Use of tobacco or nicotine containing products within 3 months prior to Check-in
  • Receipt of blood products within 2 months prior to Check-in
  • Donation of blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening
  • Participants with exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in
  • Participants who have participated in any clinical trial involving a radiolabelled investigational product within 12 months prior to Check-in

Treatment and study plan

[14C]-E6007

Drug

Oral administration

Primary outcomes

  1. Maximum concentration (Cmax) of E6007 derived from whole blood

    Time frame: Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose

  2. Area under the concentration-time curve (AUC) from time zero to infinity (AUC[0-∞]) postdose of E6007

    Time frame: Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose

  3. Total radioactivity derived from whole blood

    Time frame: Up to 11 days

  4. Total radioactivity in urine

    Time frame: Up to 11 days

  5. Total radioactivity in feces

    Time frame: Up to 11 days

Secondary outcomes

  1. Number of participants with any serious adverse event

    Time frame: Up to 11 days

  2. Number of participants with any non-serious adverse event

    Time frame: Up to 11 days

Sponsors and collaborators

Lead sponsor

EA Pharma Co., Ltd.

Industry

Registry information

Official study title

A Phase I, Open-label, Study to Determine the Absorption, Metabolism, and Excretion of [14C]-E6007 After a Single Oral Administration in Healthy Male Subjects

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 23, 2018
Registry last updated
Aug 29, 2018

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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