Obesity Other
Conditions
Interventions
Each participant will receive a single oral dose of [14C]S-309309 Oral Capsule, 30 mg containing not more than (NMT) 1.5 megabecquerel (MBq) after an overnight fast of at least 10 hours on one occasio
Sponsors
Shionogi B.V.
Eligibility
Sex/Gender
Male
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Participant must be = 30 to = 65 years of age inclusive, at the time of signing the informed consent. 2. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, safety laboratory tests, vital sign measurements, and 12-lead electrocardiogram (ECG) at the screening visit or upon admission to the CRU. 3. Participants who have regular bowel movements (ie., average stool production of = 1 and = 3 stools per day). 4. Body weight = 50 kg and BMI within the range = 18.0 to = 32.0 kg/m2 (inclusive) at the screening visit. 5. Male 6. Contraceptive use by the male participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 7. Capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 8. Must be willing and able to communicate and participate in the whole study.
Exclusion criteria
Exclusion criteria: 1. Clinically significant history or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data. 2. History of GI surgery including, but not limited to, gastric resection and/or intestinal resection that may result in a clinically significant abnormality in GI function (except for an appendectomy for noncomplicated appendicitis unless it was performed within the previous 12 months). 3. Acute diarrhea, loose stools, or constipation within 14 days prior to the screening visit or upon admission to the CRU. 4. Systolic blood pressure is outside the range of 90 to 140 mmHg, diastolic blood pressure is outside the range of 50 to 90 mmHg, or pulse rate is outside the range of 40 to 100 beats per minute (bpm) or considered ineligible by the investigator or subinvestigator at the screening visit or upon admission to the CRU. 5. Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. 6. Breast cancer within the past 10 years. 7. ALT > the upper limit of normal (ULN) at the screening visit or upon admission to the CRU. 8. AST > the ULN at the screening visit or upon admission to the CRU. 9. Alkaline phosphatase > the ULN at the screening visit or upon admission to the CRU. 10. Bilirubin > the ULN (isolated bilirubin > the ULN is acceptable if bilirubin is fractionated and direct bilirubin 450 msec at the screening visit or upon admission to the CRU. 15. Any condition requiring medication and/or other treatment, such as dietary restriction and physical therapy including current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. 16. Evidence of current SARS-CoV-2 infection. 17. Past or intended use of over-the-counter or prescription medication including recreational drugs, herbal medications, Chinese medicines, vitamins, minerals, and/or dietary supplements (other than up to 4 g of paracetamol per day) within 14 days or 5 terminal half-lives (whichever is longer) prior to dosing (Day 1). COVID-19 vaccines are accepted concomitant medications up to 7 days (168 hours) before dosing. Exceptions may apply, as determined by the investigator in consultation with the medical monitor, if each of the following criteria are met: medication with a short half-life if the washout is such that no pharmacodynamic activity is expected by the time of dosing with study intervention; and if the use of medication does not jeopardize the safety of the trial participant; and if the use of medication is not considered to interfere wit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mass balance recovery of total radioactivity in urine, faeces and urine and faeces combined (Fe and CumFe) is measured by collection of all urine and faeces from participants from Day 1 until mass balance criteria has been met or discharge from the study. 2. Total radioactivity concentrations in whole blood and plasma are measured using collection of whole blood and plasma samples from Day 1 until mass balance criteria has been met or discharge from the study. 3. Pharmacokinetic parameters (Cmax, Tmax and AUC) for total radioactivity in whole blood and plasma and for S-309309 in plasma are measured using whole blood and plasma sample collections taken from Day 1 until discharge from clinical unit. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Chemical structure of each metabolite accounting for more than 5% of circulating total radioactivity in plasma by AUC and each metabolite in urine and faeces accounting for more than 10% of the administered radioactive dose is identified using all urine and faecal collections taken from participants from Day 1 until mass balance criteria has been met or discharge from the study. 2. Routes and rates of elimination of an oral [14C]S-309309 formulation by Ae, Fe, CumAe and CumFe by interval in urine, faeces, and urine and faeces combined, and appropriate pharmacokinetic parameters of total radioactivity in whole blood and plasma and S-309309 in plasma are measured all urine, faecal, whole blood and plasma samples from participants taken from Day 1 until mass balance criteria has been met or discharge from the study. 3. Ratio of whole blood to plasma total radioactivity concentrations and association of total radioactivity with red blood cells are measured using collection of whole blood and plasma samples from Day 1 until mass balance criteria has been met or discharge from the study. 4. Adverse events, vital signs, ECGs, physical examinations, and safety laboratory tests in study participants exposed to single administration of S-309309 will be measured using vital signs measures, safety blood samples and symptom focused physical examinations taken from baseline until discharge from the clinical unit. | — |
Countries
England, United Kingdom
Contacts
Public ContactRegulatory Affairs
Outcome results
None listed