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

Healthy Male Participants Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03444818
• Other study ID #: E6007-CP3
• Secondary ID: 2017-004119-38
• Status: Completed
• Phase: Phase 1
• Start date: April 17, 2018
• Est. completion date: June 26, 2018

Study information

• Verified date: February 2018
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 26, 2018
• Est. primary completion date: June 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Male Participants

Intervention

Drug:
• [14C]-E6007
Oral administration

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit (CRU) Ltd.	Leeds	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
EA Pharma Co., Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Area under the concentration-time curve (AUC) from time zero to infinity (AUC[0-8]) postdose of E6007		Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose
Primary	Total radioactivity derived from whole blood		Up to 11 days
Primary	Total radioactivity in urine		Up to 11 days
Primary	Total radioactivity in feces		Up to 11 days
Secondary	Number of participants with any serious adverse event		Up to 11 days
Secondary	Number of participants with any non-serious adverse event		Up to 11 days