Influenza virus infection Respiratory Influenza, virus not identified
Conditions
Interventions
Volunteers will receive a single dose of 40 mg [14C]-S-033188 suspension for oral administration (20 mL) containing not more than 3.77 MBq (102 µCi) of 14C on day 1 and then will stay at the clinical
Sponsors
Shionogi Ltd
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male subjects who are able to understand the study and comply with all study procedures, and willing to provide written informed consent before screening 2. Male subjects aged from 30 years to 65 years inclusive at the time of signing informed consent 3. Male subjects who are considered healthy by the investigator (or subinvestigator) based on a medical evaluation including medical history, physical examination, laboratory tests, vital signs measurements and ECG. If any clinical abnormality is identified and/or a laboratory test value exceeds the site's standard value, subjects will be considered appropriate for the study only if the investigator judges the abnormality to be not clinically significant and not to increase the risk to the subject by participation in the study nor to compromise study endpoints 4. Male subjects whose body weight is = 50 kg and body mass index (BMI) is = 18.0 to = 32.0 kg/m2 5. Male subjects must agree to use appropriate contraception methods from the admission day (Day -1) until 3 months after discharge and agree not to donate sperm during this period
Exclusion criteria
Exclusion criteria: 1. Subjects who regularly have 1.2 × upper limit of normal (ULN) 9.2. Alanine aminotransferase (ALT) > 1.2 × ULN 9.3. Aspartate aminotransferase (AST) > 1.2 × ULN 9.4. Creatinine clearance 450 msec at screening 11. Subjects whose resting systolic pressure is outside the range of 90-140 mmHg (aged 30-45 years) or 90-160 mmHg (aged 46 to 65 years), resting diastolic pressure is outside the range of 40-90 mmHg, or a pulse rate is outside the range of 40-90 beats per minute at screening 12. Subjects with a history of surgical resection of the stomach, vagus nerve, intestines, etc (excluding appendectomy) 13. Subjects with a history of clinically significant allergic symptoms, including food allergies (excluding allergic rhinitis presenting no symptoms at the time of screening) 14. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients 15. Subjects who have a history or regular use of tobacco- or nicotine-containing products within 6 months before screening 16. Subjects with a history of drug and/or alcohol addiction within the past 2 years before screening or a positive test for drugs or alcohol at screening or admission visit 17. Regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine) 18. Subjects with a positive result on any of the tests for the serologic detection of HI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mass balance recovery after administration of a single 40-mg dose of carbon 14 labelled S-033188 ([14C] S 033188) as an oral suspension in the fasted state 2. Whole blood and plasma concentrations of total radioactivity 3. Metabolite profiling and structural identification from plasma, urine and faecal samples | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pharmacokinetics (PK) of the drug after administration of a single 40 mg dose of [14C]-S-033188 as an oral suspension in the fasted state 2. Metabolites of S-033188 identified in plasma, urine, and faeces 3. Safety and tolerability of S-033188 and S-033447 after administration of a single 40-mg dose of ([14C]-S-033188) | — |
Countries
United Kingdom
Contacts
Public ContactJon Wong
Outcome results
None listed