Healthy Volunteers
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Healthy Japanese adult males 2) The subject is aged 18 to 45 years, inclusive, at the time of signing the informed consent form 3) The subject has a BMI of 18.5 kg/m2 or more and less than 25.0 kg/m2 (rounded down to 2 decimal places) at screening 4) The subject whose body weight at screening is at least 50 kg and no more than 100 kg
Exclusion criteria
Exclusion criteria: 1) Subjects who are on a treatment for or with a history of respiratory, cardiovascular, psychiatric, neurologic, gastrointestinal, immunologic, hepatic, renal, hematopoietic or endocrine and/or other disease 2) Subjects with current or with a history of severe allergy to drugs or foods 3) The subject who is judged by the investigator or subinvestigator to be inappropriate as a subject of this study based on the results of screening tests
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Urinary and fecal excretion rates of radioactivity and cumulative excretion rates of radioactivity | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events that occurred after administration of investigational product until the end of final examination | — |
Contacts
Ono Pharmaceutical Co.,LTD.