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

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
• Capable of oral intake.
• Body weight of 50 kg or more and body mass index of 18.5 or more and less than 25.0
• 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

• Had current or previous hypersensitivity or allergy to drugs
• Had current or previous drug abuse (including use of illicit drugs) or alcoholism
• 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)
• 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).
• 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).