A Study to Determine the Absorption, Metabolism, and Excretion of [14C]-E6007 After a Single Oral Administration in Healthy Male Participants
Phase 1
Completed
- Conditions
- Healthy Male Participants
- Interventions
- Drug: [14C]-E6007
- Registration Number
- NCT03444818
- Lead Sponsor
- EA Pharma Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description [14C]-E6007 [14C]-E6007 Participants will receive a single oral dose of 60 milligrams (mg) of \[14C\]-E6007.
- Primary Outcome Measures
Name Time Method Total radioactivity in urine Up to 11 days 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 Total radioactivity in feces Up to 11 days 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
- Secondary Outcome Measures
Name Time Method Number of participants with any non-serious adverse event Up to 11 days Number of participants with any serious adverse event Up to 11 days
Trial Locations
- Locations (1)
Covance Clinical Research Unit (CRU) Ltd.
🇬🇧Leeds, West Yorkshire, United Kingdom