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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Male Participants
• Intervention / Treatment: Drug: [14C]-E6007

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom
      • Covance Clinical Research Unit (CRU) Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: [14C]-E6007; Participants will receive a single oral dose of 60 milligrams (mg) of [14C]-E6007.	Drug: [14C]-E6007; Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum concentration (Cmax) of E6007 derived from whole blood	Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose
Area under the concentration-time curve (AUC) from time zero to infinity (AUC[0-∞]) postdose of E6007	Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose
Total radioactivity derived from whole blood	Up to 11 days
Total radioactivity in urine	Up to 11 days
Total radioactivity in feces	Up to 11 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with any serious adverse event	Up to 11 days
Number of participants with any non-serious adverse event	Up to 11 days

Collaborators and Investigators

• Sponsor: EA Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 17, 2018
• Primary Completion (ACTUAL): June 26, 2018
• Study Completion (ACTUAL): June 26, 2018

Study Registration Dates

• First Submitted: February 19, 2018
• First Submitted That Met QC Criteria: February 19, 2018
• First Posted (ACTUAL): February 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 29, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Pharmacokinetics; E6007; Radioactivity
• Other Study ID Numbers: E6007-CP3; 2017-004119-38 (EUDRACT_NUMBER)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No