Phase 1 Study of S-723595
Phase 1
Completed
- Conditions
- Healthy adult
- Registration Number
- JPRN-jRCT2051200126
- Lead Sponsor
- agata Tsutae
- Brief Summary
Not available
- Detailed Description
Not available
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.
- Secondary Outcome Measures
Name Time Method