Healthy Male Participants
Conditions
Keywords
E6007, Pharmacokinetics, Radioactivity
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.
Interventions
DRUG[14C]-E6007
Oral administration
Sponsors
EA Pharma Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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 |
| 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United Kingdom
Outcome results
None listed