Clinical trial NCT05621447: A Mass Balance Study of [14C] TAS-303 in Healthy Adult Male Subjects
Official title: A Mass Balance Study of [14C] TAS-303 in Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Male Subjects
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-11-18
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion 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°C and ≦37.4°C

Exclusion 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).

Primary outcomes:
measure: Concentrations of total radioactivity in blood and plasma
timeFrame: Day1 to 8 and 10,12,14,16,18,20,22
measure: Plasma TAS-303 concentrations
timeFrame: Day1 to 8 and 10,12,14,16,18,20,22
measure: Maximum plasma concentration (Cmax)
timeFrame: Day1 to 8 and 10,12,14,16,18,20,22
measure: Area under the plasma concentration versus time curve (AUC).
timeFrame: Day1 to 8 and 10,12,14,16,18,20,22
measure: Elimination half life (T1/2)
timeFrame: Day1 to 8 and 10,12,14,16,18,20,22
measure: Radioactivity cumulative excretion rate into urine
timeFrame: Day 1 to Day 22
measure: Radioactivity cumulative excretion rate into feces.
timeFrame: Day 1 to Day 22
measure: Radioactivity excretion and excretion rate，cumulative excretion, cumulative excretion rate in all excreta (urine and feces).
timeFrame: Day 1 to Day 22
Secondary outcomes:
measure: Adverse events
timeFrame: Day 1 to Day 29
measure: Treatment-related adverse events
timeFrame: Day 1 to Day 29
measure: Number of Participants With Abnormal Laboratory Values
timeFrame: Screening period and Day -2, 8, 15, 22, 29
measure: Blood Pressure
timeFrame: Screening period and Day 1, 2, 8, 15, 22, 29
measure: Pulse rate
timeFrame: Screening period and Day 1, 8, 15, 22, 29
measure: Temperature
timeFrame: Screening period and Day 1, 2, 8, 15, 22, 29
measure: QTc interval
timeFrame: Screening period and Day 1, 8, 15, 22, 29
measure: Heart rate
timeFrame: Screening period and Day 1, 8, 15, 22, 29
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: A site selected by Taiho Pharmaceutical Co., Ltd.
Study officials:
affiliation: Taiho Pharmaceutical Co., Ltd.
name: Taiho Pharmaceutical Co., Ltd.
role: STUDY_DIRECTOR
References: