A Study of TAS3731 in Healthy Adults

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Description

To evaluate the safety of single and repeated administration of TAS3731.

Targeted Conditions

Study Overview

Start Date
January 17, 2023
Completion Date
June 1, 2024
Enrollment
250
Date Posted
January 20, 2023
Accepts Healthy Volunteers?
Yes
Gender
Male

Locations

Full Address
A site selected by Taiho Pharmaceutical Co., Ltd.
Tokyo, Japan

Eligibility

Minimum Age (years)
18
Maximum Age (years)
39
Eligibility Criteria
Key Inclusion Criteria:

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

Key Exclusion Criteria

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.
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 alcoholism
Had current or previous hypersensitivity or allergy to drugs
Suspected COVID-19 disease.

Study Contact Info

Study Contact Name
Ken Tsukamoto
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT05691660