A phase 1 study of TAS3731 in Healthy Adults

JRCT ID: jRCT2031220505

Registered date:12/12/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy adult males
• Date of first enrollment: 26/12/2022
• Target sample size: 250
• Study type: Interventional

Intervention(s)

[Single dose cohort]
TAS3731: Oral administration of 2 to 400 mg, QD
[Repeated dose cohort]
TAS3731: Oral administration of 2 to 400 mg, QD
TAS3731: Oral administration of 2 to 400 mg, BID

Outcome(s)

Primary Outcome

- Incidence rate of adverse events and adverse reactions
- Evaluation of vital signs, laboratory values and Electrocardiogram

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 40age old
• Gender: Male

Include criteria

(1)Healthy adult male subjects who provided written informed consent to participate in the study
(2)Aged 18 years or older and younger than 40 years at the time of informed consent
(3)Body weight of 50 kg or more at screening:
(4)Body mass index of 18.5 or more and less than 25.0(Japanese) or less than 30.0 kg/m2 (Caucasian)
(5)Capable of oral intake

Exclude criteria

(1)Complications 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.
(2)The 12-lead electrocardiogram at the time of the screening test was judged by the investigator to be inadequate for this study.
(3)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)
(4)The patient has the following complications or a history of the following.
a.Had current or previous drug abuse (including use of illicit drugs) or alcoholism
b.Had current or previous hypersensitivity or allergy to drugs
(5)Suspected COVID-19 disease.

Related Information

• Primary Sponsor: Sato Atsushi
• Secondary ID(s): NCT05691660