Status:
COMPLETED
A Study to Determine the Absorption, Metabolism, and Excretion of [14C]-E6007 After a Single Oral Administration in Healthy Male Participants
Lead Sponsor:
EA Pharma Co., Ltd.
Conditions:
Healthy Male Participants
Eligibility:
MALE
30-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2018
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03444818
Start Date
April 17 2018
End Date
June 26 2018
Last Update
August 29 2018
Active Locations (1)
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1
Covance Clinical Research Unit (CRU) Ltd.
Leeds, West Yorkshire, United Kingdom