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

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

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

Conditions
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Healthy Male Subjects

Intervention / Treatment
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* Drug: TAS-303, [14C]TAS-303


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAS-303, [14C]TAS-303<br> | Drug: TAS-303, [14C]TAS-303<br>* oral administration on day 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentrations of total radioactivity in blood and plasma |  | Day1 to 8 and 10,12,14,16,18,20,22 | 
| Plasma TAS-303 concentrations |  | Day1 to 8 and 10,12,14,16,18,20,22 | 
| Maximum plasma concentration (Cmax) |  | Day1 to 8 and 10,12,14,16,18,20,22 | 
| Area under the plasma concentration versus time curve (AUC). |  | Day1 to 8 and 10,12,14,16,18,20,22 | 
| Elimination half life (T1/2) |  | Day1 to 8 and 10,12,14,16,18,20,22 | 
| Radioactivity cumulative excretion rate into urine |  | Day 1 to Day 22 | 
| Radioactivity cumulative excretion rate into feces. |  | Day 1 to Day 22 | 
| Radioactivity excretion and excretion rate，cumulative excretion, cumulative excretion rate in all excreta (urine and feces). |  | Day 1 to Day 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | The number and incidence of Adverse events. | Day 1 to Day 29 | 
| Treatment-related adverse events | The number and incidence of Treatment-related adverse events. | Day 1 to Day 29 | 
| Number of Participants With Abnormal Laboratory Values |  | Screening period and Day -2, 8, 15, 22, 29 | 
| Blood Pressure |  | Screening period and Day 1, 2, 8, 15, 22, 29 | 
| Pulse rate |  | Screening period and Day 1, 8, 15, 22, 29 | 
| Temperature |  | Screening period and Day 1, 2, 8, 15, 22, 29 | 
| QTc interval |  | Screening period and Day 1, 8, 15, 22, 29 | 
| Heart rate |  | Screening period and Day 1, 8, 15, 22, 29 |