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Recruiting
NCT05691660
A Study of TAS3731 in Healthy Adults
Conditions: Healthy Adult Males
Sex: Male
Ages: 18 Years – 39 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 250
Sponsor: Taiho Pharmaceutical Co., Ltd.
Location: Japan
Summary
To evaluate the safety of single and repeated administration of TAS3731.
Eligibility Criteria
Key Inclusion Criteria:Healthy adult male subjects who provided written informed consent to participate in the studyAged 18 years or older and younger than 40 years at the time of informed consentBody weight of 50 kg or more at screening:Body mass index of 18.5 or more and less than 25.0Capable of oral intake.Key Exclusion CriteriaComplications or history of diseases that may affect absorption, distribution, metabolism, or excretion of the investigational drug, such as hepatic/biliary tract disease, renal/urologic disease, or gastrointestinal disease.
The stomach or small intestine has been resected.The 12-lead electrocardiogram at the time of the screening test was judged by the investigator to be inadequate for this study.Had any concurrent disease (including symptoms and signs; however, diseases that do not affect evaluations in the study such as asymptomatic pollinosis and wart are excluded)The patient has the following complications or a history of the following.Had current or previous drug abuse (including use of illicit drugs) or alcoholismHad current or previous hypersensitivity or allergy to drugsSuspected COVID-19 disease.
Source: ClinicalTrials.gov (NCT05691660). StuddyBuddy aggregates publicly available trial information.