A Study of TAS3731 in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-17

Study Completion Date

2024-05-21

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Adult Males

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Single dose cohort

Group Type EXPERIMENTAL

TAS3731 Dose1

Intervention Type DRUG

Oral administration,1 day,QD

Placebo

Intervention Type DRUG

Oral administration, 1 day,QD

Repeated dose cohort Once daily (QD)

Group Type EXPERIMENTAL

TAS3731 Dose2

Intervention Type DRUG

Oral administration,7 days,QD

Placebo

Intervention Type DRUG

Oral administration, 7 days,QD

Repeated dose cohort Twice daily (BID)

Group Type EXPERIMENTAL

TAS3731 Dose3

Intervention Type DRUG

Oral administration,7 days,BID

Placebo

Intervention Type DRUG

Oral administration, 7 days,BID

Interventions

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TAS3731 Dose1

Oral administration,1 day,QD

Intervention Type DRUG

TAS3731 Dose2

Oral administration,7 days,QD

Intervention Type DRUG

TAS3731 Dose3

Oral administration,7 days,BID

Intervention Type DRUG

Placebo

Oral administration, 1 day,QD

Intervention Type DRUG

Placebo

Oral administration, 7 days,QD

Intervention Type DRUG

Placebo

Oral administration, 7 days,BID

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes