Phase 1 Study of S-723595

JRCT ID: jRCT2051200126

Registered date:29/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy adult
• Date of first enrollment: 18/01/2021
• Target sample size: 94
• Study type: Interventional
• Intervention(s): S-723595 tablet or placebo tablet for oral administration

Outcome(s)

Primary Outcome

-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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 55age old
• Gender: Male
• Include criteria: Japanese or Caucasian male >= 20 to =< 55 years of age, at the time of signing the informed consent form (ICF).
• Exclude 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.

Related Information

• Primary Sponsor: Nagata Tsutae