Phase 1 Study of S-723595

Phase 1

• Conditions: Healthy adult

• Registration Number: JPRN-jRCT2051200126
• Lead Sponsor: agata Tsutae

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 94

Inclusion Criteria

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-To evaluate the safety and tolerability of S-723595 after administration of a single oral dose of S-723595 in Japanese healthy adult participants.<br>-To evaluate the safety and tolerability of S-723595 after administration of multiple oral doses of S-723595 in Japanese/Caucasian healthy adult participants.<br>-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.