Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection Infections and Infestations
Conditions
Interventions
Each participant will receive a single oral dose of 375 mg [14C]-S-217622 Oral Suspension (12.2 mg/g [active pharmaceutical ingredient/total oral suspension]), containing NMT 3.5 MBq on one occasion.
Sponsors
Shionogi B.V.
Eligibility
Sex/Gender
Male
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 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 body mass index (BMI) within the range =18.0 to =32.0 kg/m2 (inclusive) at the screening visit or upon admission to the CRU. 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. Participants should also not donate sperm for the duration of the study and for 100 days after the study intervention administration. 7. Capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol. 8. Must be willing and able to communicate and participate in the whole study (with the exception of pharmacogenomics (PGx) testing, which is optional).
Exclusion criteria
Exclusion criteria: 1. History or presence of/significant history of or 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. Alanine aminotransaminase (ALT) > the upper limit of normal (ULN) at the screening visit or upon admission to the CRU. 8. Aspartate aminotransaminase (AST) > the ULN at the screening visit or upon admission to the CRU. 9. Bilirubin > the ULN (isolated bilirubin > the ULN is acceptable if bilirubin is fractionated and direct bilirubin 7.0 mmol/L), hematology or urinalysis result as judged by the investigator. 13. QT interval corrected for heart rate according to Fridericia’s formula (QTcF) > 450 msec at the screening visit or upon admission to the CRU. 14. Any condition requiring medication and/or other treatment, such as dietary restriction and physical therapy including current SARS-CoV-2 infection. 15. Evidence of current SARS-CoV-2 infection. 16. 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 72 hours before dosing. 17. Participants who have had a COVID-19 vaccine within 72 hours before dosing. 18. Live vaccine(s) within 1 month prior to screening, or plans to receive such vaccines during the study. 19. Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood. 20. Participants who report exposure to more than 4 new chemical entities within 12 months prior to dosing. 21. Participants who have received any investigational study intervention/IMP in a clinical research study within the 90 days prior to the plan
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mass balance recovery of total radioactivity in urine, feces and urine and feces combined: Fe and CumFe at multiple timepoints up to 456 h post-dose 2. Whole blood and plasma concentrations of total radioactivity at multiple timepoints up to 456 h post-dose 3. PK parameters for total radioactivity in whole blood and plasma and for S 217622 in plasma including but not limited to: Cmax, Tmax and AUC at multiple timepoints up to 456 h post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Identification of the chemical structure of each metabolite accounting for more than 5% (in plasma) by AUC of circulating total radioactivity and identification of each metabolite in urine and feces that account for more than 10% of the administered radioactive dose at multiple timepoints up to 456 h post-dose 2. Routes and rates of elimination of an oral [14C]-S-217622 formulation by Ae, Fe, CumAe and CumFe by interval in urine, feces, and urine and feces combined, and appropriate PK parameters of total radioactivity in whole blood and plasma and S 217622 in plasma at multiple timepoints up to 456 h post-dose 3. The ratio of whole blood to plasma total radioactivity concentrations and the association of total radioactivity with red blood cells at multiple timepoints up to 456 h post-dose 4. AEs, vital signs, ECGs, physical examinations and safety laboratory tests in study participants exposed to a single administration of S 217622, from the time of signing the informed consent form up until discharge from the study | — |
Countries
England, United Kingdom
Contacts
Public ContactRegulatory Affairs
Outcome results
None listed