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

EA Pharma

Status and phase

Completed

Phase 1

Conditions

Healthy Male Participants

Treatments

Drug: [14C]-E6007

Study type

Interventional

Funder types

Industry

Identifiers

NCT03444818

2017-004119-38 (EudraCT Number)

E6007-CP3

Details and patient eligibility

About

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

Enrollment

6 patients

Sex

Male

Ages

30 to 55 years old

Volunteers

Accepts Healthy Volunteers

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