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

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

Official Title
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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

Conditions
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Healthy Male Participants

Intervention / Treatment
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* Drug: [14C]-E6007


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [14C]-E6007<br>Participants will receive a single oral dose of 60 milligrams (mg) of [14C]-E6007. | Drug: [14C]-E6007<br>* Oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radioactivity, E6007, Pharmacokinetics