A mass balance study of [14C] TAS-303 in healthy adult male subjects
- Conditions
- Healthy adult male volunteer
- Registration Number
- jRCT2071220056
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 6
(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 and =<37.4
(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).
Study & Design
- Study Type
- Interventional
- Study Design
- single assignment
- Primary Outcome Measures
Name Time Method Concentrations of total radioactivity in blood and plasma Concentrations of total radioactivity in blood and plasma, plasma TAS-303 concentrations and the pharmacokinetics parameters of TAS-303
Radioactivity excretion and excretion rate into urine and feces Radioactivity excretion and excretion rate, cumulative excretion, cumulative excretion rate into urine and feces
Radioactivity excretion and excretion rate in all excreta Radioactivity excretion and excretion rate, cumulative excretion, cumulative excretion rate in all excreta (urine and faeces)
Plasma, urinary, and fecal metabolite profiles of TAS-303 Plasma, urinary, and fecal metabolite profiles of TAS-303, and structural estimation
- Secondary Outcome Measures
Name Time Method