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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05621447
Other study ID # 10060080
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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