Phase 1 Study of S-723595

A Phase 1, Randomized, Double-Blind, Single-Ascending-Dose, and Food Effect Study to Assess the Safety, Tolerability, and Pharmacokinetics of S-723595 in Healthy Adult Participants (Part 1); and A Phase 1, Randomized, Double-Blind, Multiple-Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of S-723595 and A Drug-Drug Interaction Study with the CYP3A Substrate, Midazolam, in Healthy Adult Participants (Part 2) - A Phase 1, Single-Dose, Multiple-Dose, Food Effect, and Midazolam Drug-Drug Interaction Study of S-723595

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2051200126

Enrollment

Registered

2021-01-29

Start date

2021-01-18

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

Healthy adult

Interventions

S-723595 tablet or placebo tablet for oral administration

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Japanese or Caucasian male >= 20 to =< 55 years of age, at the time of signing the informed consent form (ICF).

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.

Design outcomes

Primary

Measure	Time frame
-To evaluate the safety and tolerability of S-723595 after administration of a single oral dose of S-723595 in Japanese healthy adult participants. -To evaluate the safety and tolerability of S-723595 after administration of multiple oral doses of S-723595 in Japanese/Caucasian healthy adult participants. -To evaluate the effect of S-723595 after administration of multiple oral doses of S-723595 on the pharmacokinetics of midazolam, a substrate for cytochrome P450 (CYP) 3A in Caucasian healthy adult participants.	—

Measure

Time frame

-To evaluate the safety and tolerability of S-723595 after administration of a single oral dose of S-723595 in Japanese healthy adult participants. -To evaluate the safety and tolerability of S-723595 after administration of multiple oral doses of S-723595 in Japanese/Caucasian healthy adult participants. -To evaluate the effect of S-723595 after administration of multiple oral doses of S-723595 on the pharmacokinetics of midazolam, a substrate for cytochrome P450 (CYP) 3A in Caucasian healthy adult participants.

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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