A mass balance study of [14C] TAS-303 in healthy adult male subjects

JRCT ID: jRCT2071220056

Registered date:07/10/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Healthy adult male volunteer
• Date of first enrollment: 12/09/2022
• Target sample size: 6
• Study type: Interventional
• Intervention(s): Orally administer 40 mL of the liquid containing [14C]TAS-303 (approximately 1 MB) and 18 mg of TAS-303 on day 1.

Outcome(s)

Primary Outcome

- Concentrations of total radioactivity in blood and plasma, plasma TAS-303 concentrations and the pharmacokinetics parameters of TAS-303
- Radioactivity excretion and excretion rate, cumulative excretion, cumulative excretion rate into urine and feces.
- 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, and structural estimation.

Key inclusion & exclusion criteria

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

Include criteria

(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

Exclude criteria

(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).

Related Information

• Primary Sponsor: Jinhong Huang