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

Phase 1

Completed

• Conditions: Healthy Male Subjects
• Interventions: Drug: TAS-303, [14C]TAS-303

• Registration Number: NCT05621447
• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-07
• Study First Submitted: 2022-10-30
• Primary Completion: 2022-11-03
• Study First Submitted QC: 2022-11-17
• Study First Posted: 2022-11-18
• Study Completion: 2023-02-22
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-04
• Last Update Posted: 2023-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAS-303, [14C]TAS-303	TAS-303, [14C]TAS-303	-

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

A site selected by Taiho Pharmaceutical Co., Ltd.; 🇯🇵 Tokyo, Japan