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To evaluate the pharmacokinetics, mass balance recovery, metabolite profile and metabolite identification of [14C]TAS-303 following oral single dose
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAS-303, [14C]TAS-303 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAS-303, [14C]TAS-303 | Drug | oral administration on day 1 |
|
| Measure | Description | 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 |
| 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. |
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Inclusion Criteria:
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:
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).
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| Name | Affiliation | Role |
|---|---|---|
| Taiho Pharmaceutical Co., Ltd. | Taiho Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A site selected by Taiho Pharmaceutical Co., Ltd. | Tokyo | Japan |
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.
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| ID | Term |
|---|---|
| C000718062 | TAS-303 |
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| 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 |