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To evaluate the pharmacokinetics, mass balance recovery, metabolite profile and metabolite identification of [14C]TAS-205 following oral single doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAS-205, [14C]TAS-205 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAS-205, [14C]TAS-205 | Drug | single oral administration under fasted conditions on day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of total radioactivity in blood and plasma, plasma TAS-205 concentrations and the pharmacokinetics parameters of TAS-205 | Day 1 to Day 8 | |
| Radioactivity excretion and excretion rate,cumulative excretion, cumulative excretion rate into urine and feces. | Day 1 to Day 8 | |
| Radioactivity excretion and excretion rate,cumulative excretion, cumulative excretion rate in all excreta (urine and feces). | Day 1 to Day 8 | |
| Plasma, urinary, and fecal metabolite profiles of TAS-205 , and structural estimation. | Day 1 to Day 8 |
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Key Inclusion Criteria:
Key Exclusion Criteria
Systolic blood pressure: <90 mmHg or ≥140 mmHg, Diastolic blood pressure: <40 mmHg or ≥90 mmHg, Pulse rate: <40 beats per minute (bpm) or ≥100 bp, Body temperature: 35.0°C or ≥37.1°C
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39840517 | Derived | Hanada R, Takenaka T. Phase 1 Mass Balance Study of Pizuglanstat: An Investigational Hematopoietic Prostaglandin D Synthase Inhibitor. Clin Pharmacol Drug Dev. 2025 Mar;14(3):200-208. doi: 10.1002/cpdd.1504. Epub 2025 Jan 22. |
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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 |
|---|---|
| C000712251 | TAS-205 |
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