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Study to Evaluate the Mass Balance and Biotransformation of Single Dose [14C]SHR4640 in Chinese healthy adult male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]SHR4640 | Experimental | Patients will receive single dose of [14C]SHR4640 (Suspension, 10mg/80μCi). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]SHR4640 | Drug | Patients will receive single dose of orally [14C]SHR4640 on Day 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Quantitive analysis of whole radioactivity of excrement of orally administered [14C]SHR4640 in Chinese healthy adult male volunteers to obtain the mass balance data and the main excretion pathway in human body by liquid scintillation counter. | The percentage of radioactive dose of [14C] radiolabelled SHR4640 recovered in urine, faeces and in total, up to Day 10 (approx). | Up to 10 days (approx) from the start of administration. |
| Quantitive analysis of the concentrations of SHR4640 in plasma using the validated LC-MS/MS to obtain pharmacokinetic data. | The concentrations of SHR4640 in plasma up to Day 10. | Up to 10 days (approx) from the start of administration. |
| Identification of the main metabolite and biotransformation pathway of SHR4640 and investigation of metabolite in plasma by LC-HR MS. | Proportion of different metabolites. | Up to 10 days (approx) from the start of administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events. | Laboratory indicators, 12-lead electrocardiogram (ECG), physical examination,vital signs, adverse events (NCI-CTC AE 5.0), etc. | Up to 10 days (approx) from the start of administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital, Soochow University | Suzhou | Jiangsu | 215006 | China |
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