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This is a single-center, open label and single-dose clinical trail, to explore the body mass balance and identify the major metabolites in Chinese adult male healthy volunteers after a single oral dose of [14C]Sulfatinib, to obtain the pharmacokinetic parameters of plasma and observe the safety of healthy volunteers after a single oral dose of [14C]Sulfatinib.
In order to determine the optimal time point for sample collection, this study will be divided into two stages: the first stage, two volunteers will be enrolled, the volunteers should stop collecting the corresponding samples by the investigators based on radioactive test results, safety results combined with the actual comprehensive situation. And in the second stage sample collection time for another four volunteers will be determined and adjusted according to the results of the first stage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]Sulfatinib | Other | This is a single center and single dose in 6 volunteers. Subject would take a suspension containing 300 mg of Sulfatinib (containing about 100 μCi of radioactivity) within 1 hour after standard breakfast. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]Sulfatinib | Drug | 300 mg Sulfatinib with 100 µCi [14C] |
|
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration (AUCt) of total radioactivity of [14C] Sulfatinib | The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration. | Measured from the 0 hour to 216 hours |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the Maximum observed plasma concentration (Cmax) of total radioactivity of [14C] Sulfatinib | Maximum observed concentration, occurring at Tmax. | Measured from the 0 hour to 216 hours |
| To investigate the time to Cmax (peak time, Tmax) of total radioactivity of [14C] Sulfatinib |
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Inclusion Criteria:
Exclusion Criteria:
Age of 18-50 (inclusive), Male
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| Name | Affiliation | Role |
|---|---|---|
| Ke LI, PhD | Hutchison Medipharma Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hutchison Medipharma Ltd. | Shanghai | Shanghai Municipality | 201203 | China |
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| ID | Term |
|---|---|
| C000717729 | surufatinib |
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This is single centre, open label, single dose study
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open label
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The time at which maximum plasma concentration (Cmax) is observed. |
| Measured from the 0 hour to 216 hours |
| To investigate Half-life (t1/2) of total radioactivity of [14C] Sulfatinib | The time at which Half-life (t1/2) is observed. | Measured from the 0 hour to 216 hours |
| To obtain mass balance data after a single oral dose of [14C] Sulfatinib | Quantitative analysis of total radioactivity in the excretion of Sulfatinib | Measured on the Day1 to Day15 |
| To observe the safety of healthy volunteers after a single oral dose of [14C]Sulfatinib. | Adverse Event (AE) monitoring of [14C] Sulfatinib | Measured from the date signed ICF to within 15 days after the single dose |