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

NCT ID: NCT03444818

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-17
• Study Completion Date: 2018-06-26

Brief Summary

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

Conditions

Healthy Male Participants

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

[14C]-E6007

Participants will receive a single oral dose of 60 milligrams (mg) of \[14C\]-E6007.

Group Type: EXPERIMENTAL

[14C]-E6007

Intervention Type: DRUG

Oral administration

Interventions

[14C]-E6007

Oral administration

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

EA Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Covance Clinical Research Unit (CRU) Ltd.

Leeds, West Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

2017-004119-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

E6007-CP3

Identifier Type: -

Identifier Source: org_study_id