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

Healthy Male Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05621447
• Other study ID #: 10060080
• Status: Completed
• Phase: Phase 1
• Start date: September 7, 2022
• Est. completion date: February 22, 2023

Study information

• Verified date: August 2023
• Source: Taiho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 22, 2023
• Est. primary completion date: November 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy Male Subjects

Intervention

Drug:
• TAS-303, [14C]TAS-303
oral administration on day 1

Locations

Country	Name	City	State
Japan	A site selected by Taiho Pharmaceutical Co., Ltd.	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentrations of total radioactivity in blood and plasma		Day1 to 8 and 10,12,14,16,18,20,22
Primary	Plasma TAS-303 concentrations		Day1 to 8 and 10,12,14,16,18,20,22
Primary	Maximum plasma concentration (Cmax)		Day1 to 8 and 10,12,14,16,18,20,22
Primary	Area under the plasma concentration versus time curve (AUC).		Day1 to 8 and 10,12,14,16,18,20,22
Primary	Elimination half life (T1/2)		Day1 to 8 and 10,12,14,16,18,20,22
Primary	Radioactivity cumulative excretion rate into urine		Day 1 to Day 22
Primary	Radioactivity cumulative excretion rate into feces.		Day 1 to Day 22
Primary	Radioactivity excretion and excretion rate,cumulative excretion, cumulative excretion rate in all excreta (urine and feces).		Day 1 to Day 22
Secondary	Adverse events	The number and incidence of Adverse events.	Day 1 to Day 29
Secondary	Treatment-related adverse events	The number and incidence of Treatment-related adverse events.	Day 1 to Day 29
Secondary	Number of Participants With Abnormal Laboratory Values		Screening period and Day -2, 8, 15, 22, 29
Secondary	Blood Pressure		Screening period and Day 1, 2, 8, 15, 22, 29
Secondary	Pulse rate		Screening period and Day 1, 8, 15, 22, 29
Secondary	Temperature		Screening period and Day 1, 2, 8, 15, 22, 29
Secondary	QTc interval		Screening period and Day 1, 8, 15, 22, 29
Secondary	Heart rate		Screening period and Day 1, 8, 15, 22, 29