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

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

Study Overview

• Status: Completed
• Conditions: Healthy Male Subjects
• Intervention / Treatment: Drug: TAS-303, [14C]TAS-303

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • A site selected by Taiho Pharmaceutical Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAS-303, [14C]TAS-303	Drug: TAS-303, [14C]TAS-303; oral administration on day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Taiho Pharmaceutical Co., Ltd.
• Investigators: Study Director: Taiho Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2022
• Primary Completion (Actual): November 3, 2022
• Study Completion (Actual): February 22, 2023

Study Registration Dates

• First Submitted: October 30, 2022
• First Submitted That Met QC Criteria: November 17, 2022
• First Posted (Actual): November 18, 2022

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 10060080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be shared according to the Sponsor policy on data sharing. Taiho policy on data sharing may be found at https://www.taiho.co.jp/en/science/policy/clinical_trial_information_disclosure_policy/index.html.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No