COVID-19
Conditions
Interventions
Oral administration of S-217622 or placebo
Sponsors
Nagata Tsutae
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Japanese healthy adult male participants (SAD Part, DDI with dexamethasone and prednisolone Part) Japanese healthy adult male, white healthy adult male or Japanese healthy adult female participants (MAD Part) Japanese healthy adult male and female participants (FE Part, DDI with midazolam Part) White healthy adult male and female participants (W-MAD Part) Participants must be 20 to 55 years of age inclusive, at the time of signing the informed consent form (SAD Part, MAD Part, DDI Part, FE Part, W-MAD Part) Participants must be 65 years of age or older inclusive, at the time of signing the informed consent form (Elderly Part)
Exclusion criteria
Exclusion criteria: History of cardiovascular, respiratory, hepatic, renal, gastrointestinal, 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 Positive SARS-CoV-2 RT-PCR test at admission
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events, physical examination, laboratory tests, vital signs, 12-lead ECG, holter ECG Pharmacokinetics (SAD Part, MAD Part, W-MAD Part, Elderly Part) Dexamethasone, prednisolone, and midazolam: Cmax, Tmax, AUC0-last, AUC0-inf, t1/2,z, lambdaz, MRT, CL/F, Vz/F (DDI Part) S-217622: Cmax, Tmax, AUC0-last, AUC0-inf, t1/2,z, lambdaz, MRT, CL/F, Vz/F (FE Part) | — |
Contacts
Public ContactCorporate Communications Department
Shionogi & Co., Ltd.
Outcome results
None listed