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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031240405

Enrollment

130

Registered

2024-10-15

Start date

2024-10-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

RS virus infection

Interventions

S-337395 or placebo by oral administration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Part 1,3,4,5 (Group1) : -Those who aged >=18 to ==18.5 to == 65 years, at the time of signing the ICF -Those who have BMI of >=18.5 to == 40 kg

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Part 1,3,4 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	—

Contacts

Public ContactCorporate Communications Department

Shionogi & Co., Ltd.

shionogiclintrials-admin@shionogi.co.jp+81-6-6209-7885

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026