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A Mass Balance Study of [14C] TAS-303 in Healthy Adult Male Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Mass Balance Study of [14C] TAS-303 in Healthy Adult Male Subjects

NCT05621447•Taiho Pharmaceutical Co., Ltd.

Summary

To evaluate the pharmacokinetics, mass balance recovery, metabolite profile and metabolite identification of \[14C\]TAS-303 following oral single dose

Eligibility

Age

18 - 40 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. Capable of oral intake.
•4. Body weight of 50 kg or more and body mass index of 18.5 or more and less than 25.0
•5. Had blood pressure, pulse rate, and body temperature meeting any of the following at screening:
•Systolic blood pressure: ≧90 mmHg and ≦139 mmHg, Diastolic blood pressure: ≧40 mmHg and ≦89 mmHg, Pulse rate: ≧40 beats per minute (bpm) and ≦99 bpm, Body temperature: ≧35.0°C and ≦37.4°C

Exclusion Criteria

•1. Had current or previous hypersensitivity or allergy to drugs
•2. Had current or previous drug abuse (including use of illicit drugs) or alcoholism
•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. Received a radioisotope-labeled substance or subject to a large quantity of radiation exposure\* within 12 months before the first dose of TAS-303.
•\* A large quantity of radiation exposure includes continuous X-ray irradiation, computed tomography (CT) scan, gastric barium test, and positron emission tomography (PET) scan, excluding tests with low radiation exposure (e.g., chest, bone, or dental X-ray examination, or X-ray examination before boarding an airplane).
•5. Occupationally exposed to radiation within a year before the first dose of TAS-303 (such as operators who are involved in nuclear power or radiation operations).

Locations (1)

A site selected by Taiho Pharmaceutical Co., Ltd.

Tokyo, Japan

Key Dates

Start Date

September 7, 2022

Primary Completion Date

November 3, 2022

Completion Date

February 22, 2023

Last Updated

August 7, 2023

Enrollment

ACTUAL participants

Conditions

Healthy Male Subjects

Interventions

TAS-303, [14C]TAS-303

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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 7, 2023Data 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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A Mass Balance Study of [14C] TAS-303 in Healthy Adult Male Subjects

Inclusion Criteria

Exclusion Criteria

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