A Phase 1 study of S-217622

Phase 1

• Conditions: COVID-19

• Registration Number: JPRN-jRCT2031210202
• Lead Sponsor: agata Tsutae

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 201

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events, physical examination, laboratory tests, vital signs, 12-lead ECG, holter ECG<br>Pharmacokinetics (SAD Part, MAD Part, W-MAD Part, Elderly Part)<br>Dexamethasone, prednisolone, and midazolam: Cmax, Tmax, AUC0-last, AUC0-inf, t1/2,z, lambdaz, MRT, CL/F, Vz/F (DDI Part)<br>S-217622: Cmax, Tmax, AUC0-last, AUC0-inf, t1/2,z, lambdaz, MRT, CL/F, Vz/F (FE Part)