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This is a phase 1, single-center, single-dose, open-label mass-balance study to evaluate radioactive recovery rate, radioactive PK characteristics, metabolite identification, and to observe the safety in healthy male subjects of [14C] LPM3770164.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C] LPM3770164 | Experimental | 20 mg/150 µCi [14C] LPM3770164 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C] LPM3770164 | Drug | The subjects are required to take 20 mg/150 µCi [14C] LPM3770164 tablet (s) in the fasted state with a total of approximately 240 mL of water to ensure completion within 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery of total radioactivity in excreta (urine and feces) per collection period; | within up to 40 days after dosing | |
| Cumulative recovery of total radioactivity in excreta (urine and feces) | within up to 40 days after dosing | |
| Percentage of parent drug and its metabolites in plasma to total radioactivity exposure (% AUC) in human plasma | within up to 40 days after dosing | |
| Percentage of parent drug and its metabolites in urine and feces to administered dose (% administered dose) | within up to 40 days after dosing | |
| Identification of major metabolites in human plasma, urine and feces | within up to 40 days after dosing | |
| Peak concentration (Cmax) of total radioactivity in human plasma | within up to 40 days after dosing | |
| Area Under the Curve from time 0 extrapolated to infinity (AUC0-inf) of total radioactivity in human plasma. | within up to 40 days after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent adverse event | From baseline to 40 days after doing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yiqing Zhao, Doctor | Contact | +8613358100007 | 13358100007@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Jiangnan University | Wuxi | Jiangsu | China |
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| ID | Term |
|---|---|
| D006816 | Huntington Disease |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| D003704 | Dementia |
| D002819 | Chorea |
| D020820 | Dyskinesias |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |