A Study of TAS3731 in Healthy Adults

Phase 1CompletedNCT05691660

Taiho Pharmaceutical Co., Ltd.238 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

238

Conditions

Healthy Adult Males

Interventions

TAS3731 Dose1DRUG

Oral administration,1 day,QD

TAS3731 Dose2DRUG

Oral administration,7 days,QD

TAS3731 Dose3DRUG

Oral administration,7 days,BID

Placebo

Eligibility

Sex: MALEMin age: 18 YearsMax age: 39 YearsHealthy volunteers:

Medical Language ↔ Plain English

Key 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. Key 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

Outcomes

Primary Outcomes

The number and incidence rate of adverse events

Time frame: Single dose cohort：Day 1 to 7, Repeated dose cohort：Day 1 to 16

The number and incidence rate of adverse drug reactions

Time frame: Single dose cohort：Day 1 to 7, Repeated dose cohort：Day 1 to 16

Evaluation of Systolic and Diastolic blood pressure

Time frame: Single dose cohort：Change from Baseline Systolic and Diastolic Blood Pressure at 7 days, Repeated dose cohort：Change from Baseline Systolic and Diastolic Blood Pressure at 16 days

Evaluation of pulse rate

Time frame: Single dose cohort：Change from Baseline pulse rate at 7 days, Repeated dose cohort：Change from Baseline pulse rate at 16 days

Evaluation of body temperature

Time frame: Single dose cohort：Change from Baseline body temperature at 7 days, Repeated dose cohort：Change from Baseline body temperature at 16 days

Number of participants with abnormal laboratory values

Time frame: Single dose cohort：Change in number of participants with abnormal laboratory values between baseline and 7 days, Repeated dose cohort：Change in number of participants with abnormal laboratory values between baseline and 16 days

Evaluation of QT interval corrected for heart rate using Fridericia's formula(QTcF) interval

Time frame: Single dose cohort：Change from Baseline QTcF interval at 7 days, Repeated dose cohort：Change from Baseline QTcF interval at 16 days

Evaluation of RR-interval

Time frame: Single dose cohort：Change from Baseline Evaluation of RR-interval at 7 days, Repeated dose cohort：Change from Baseline Evaluation of RR-interval at 16 days

Data from ClinicalTrials.gov

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