A Mass Balance Study of [14C] TAS5315 in Healthy Adult Subjects

Completed

Recruitment & Eligibility

Inclusion Criteria

Aged 18 or older and younger than 40 years at the time of consent
Weigh at least 45.0 kg at the time of screening tests with a body mass index (BMI, weight [kg]/[height {m}]2) ranging from 18.0 to < 25.0 kg/m2
Blood pressure and body temperature obtained in screening tests within the following ranges
a Systolic blood pressure (in supine position), 90 to 139 mmHg
b Diastolic blood pressure (in supine position), 40 to 89 mmHg
c Body temperature ranging from 35.0 to 37.4
Judged to be healthy by the investigator based on the examination findings (subjective symptoms and objective findings), blood pressure, pulse rate, body temperature, 12-lead ECG, and laboratory tests (hematology test, biochemistry test, and urinalysis) at the time of screening tests

Exclusion Criteria

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)
Had any severe disease history that may recur during the study period.

Primary Outcome Measures

Name	Time	Method
Plasma and blood radioactivity concentrations		Plasma TAS5315 concentrations and their pharmacokinetic parameters, and blood/plasma radioactivity concentration ratio
Excretion and rate of radioactivity in urine and feces		Cumulative excretion and cumulative excretion rate
Total amount and rate of excretion of radioactivity in urine and feces		Total amount and rate of cumulative excretion
Metabolite profile and structural estimation of TAS5315		Metabolite profile and structural estimation of TAS5315 in plasma, urine and feces