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

JRCT ID: jRCT2071230061

Registered date:12/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: healthy adult males
• Date of first enrollment: 30/10/2023
• Target sample size: 6
• Study type: Interventional
• Intervention(s): Orally administration of 8 mL (containing 4 mg of TAS5315 and about 1 MBq of administered radioactivity) of the prepared solution

Outcome(s)

Primary Outcome

-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 in plasma, urine and feces

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 40age old
• Gender: Male

Include criteria

1) Aged 18 or older and younger than 40 years at the time of consent
2) 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
3) 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
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

Exclude criteria

1) 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)
2) Had any severe disease history that may recur during the study period.

Related Information

• Primary Sponsor: Ali Nasermoaddeli
• Secondary ID(s): Nil known