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

NCT05621447 | Completed Phase 1

• 1 other identifier: 10060080
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Male Subjects

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (8)

• Adverse events

  Day 1 to Day 29

• 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

Study Arms (1)

TAS-303, [14C]TAS-303

EXPERIMENTAL

Drug: TAS-303, [14C]TAS-303

Interventions

TAS-303, [14C]TAS-303 DRUG

oral administration on day 1

TAS-303, [14C]TAS-303

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult male subjects who provided written informed consent to participate in the study
• Aged 18 years or older and younger than 40 years at the time of informed consent
• Capable of oral intake.
• Body weight of 50 kg or more and body mass index of 18.5 or more and less than 25.0
• 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

You may not qualify if:

• Had current or previous hypersensitivity or allergy to drugs
• Had current or previous drug abuse (including use of illicit drugs) or alcoholism
• 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)
• 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).
• 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).

Sponsors & Collaborators

• Taiho Pharmaceutical Co., Ltd.: lead

Study Sites (1)

A site selected by Taiho Pharmaceutical Co., Ltd.

Tokyo, Japan

Location

MeSH Terms

Interventions

TAS-303

Study Officials

• Taiho Pharmaceutical Co., Ltd.

  Taiho Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2022
• First Posted: November 18, 2022
• Study Start: September 7, 2022
• Primary Completion: November 3, 2022
• Study Completion: February 22, 2023
• Last Updated: August 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)