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A phase 1 study to evaluate the relative bioavailability of and food effect on pharmacokinetics of S-337395 tablets in Japanese healthy adults, and the safety of multiple doses of S-337395 in Japanese healthy elderly participants

A phase 1 study to evaluate the BA/FE of S-337395 tablets in adults, and safety in elderly participants

Gomez Juan Carlos

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

shionogiclintrials-admin@shionogi.co.jp

Corporate Communications Department

Shionogi & Co., Ltd.

1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Osaka

+81-6-6209-7885

shionogiclintrials-admin@shionogi.co.jp

Recruiting

Oct. 21, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

Part 1,3,4,5 6,7 (Group1) :
-Those who aged >=18 to =<55 years, at the time of signing the ICF.
-Those who have BMI of >=18.5 to =<30.0
Part 2,5 (Group2) :
-Those who aged >= 65 years, at the time of signing the ICF
-Those who have BMI of >=18.5 to =< 30.0, and body weight of >= 40 kg

Considered by the investigator or subinvestigator (suitably qualified) to be ineligible for the study due to a history of or current condition of significant metabolic or endocrine, hepatic, renal, hematological, cardiovascular, gastrointestinal or neurological disorders that are considered by the investigator to constitute a safety risk upon the study drug administration or to interfere with the interpretation of data.
If abnormalities in liver or kidney function values were detected at screening or on admission

Both

RS virus infection

S-337395 or placebo by oral administration

Part 1,3,4,6,7
Cmax, C24, Tmax, AUC0-last, AUC0-inf, t1/2,z, MRT, CL/F, and Vz/F
Part 2,5
Adverse events, physical examination, laboratory tests (hematology, blood chemistry, and urinalysis), vital signs (systolic and diastolic blood pressure, pulse rate, respiratory rate, and temperature), and 12 lead ECG

+81-42-625-5216

Oct. 16, 2024

No

none