A Phase 1 study of S-217622

JRCT ID: jRCT2031210202

Registered date:16/07/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: COVID-19
• Date of first enrollment: 22/07/2021
• Target sample size: 201
• Study type: Interventional
• Intervention(s): Oral administration of S-217622 or placebo

Outcome(s)

Primary Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 55age old
• Gender: Both

Include 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)

Exclude 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

Related Information

• Primary Sponsor: Nagata Tsutae