A Study of TAS3731 in Healthy Adults

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Dose Escalating Study of TAS3731 in Healthy Adults

NCT05691660•Taiho Pharmaceutical Co., Ltd.

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Summary

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

Eligibility

Age

18 - 39 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion 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.

Exclusion 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.
•1. Had current or previous drug abuse (including use of illicit drugs) or alcoholism
•2. Had current or previous hypersensitivity or allergy to drugs
•5. Suspected COVID-19 disease.

Locations (1)

A site selected by Taiho Pharmaceutical Co., Ltd.

Tokyo, Japan

Key Dates

Start Date

January 17, 2023

Primary Completion Date

May 21, 2024

Completion Date

May 21, 2024

Last Updated

August 14, 2024

Enrollment

238

ACTUAL participants

Conditions

Healthy Adult Males

Interventions

TAS3731 Dose1

DRUG

TAS3731 Dose2

DRUG

TAS3731 Dose3

DRUG

Placebo

DRUG

Placebo

DRUG

Placebo

DRUG

Drug-Drug Interaction Study Between TAK-272 and Itraconazole, Digoxin or Midazolam

NCT02370615

Japanese Healthy Adult Males

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 14, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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