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This is an open-label, single center, 1-period study in healthy adult male subjects to assess absorption, metabolism, and excretion of HMS5552 after a single oral administration of 50 mg (90 μCi) of [14C]-HMS5552.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [C14]-labelled HMS5552 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HMS5552 | Drug | [14C]-labelled HMS5552 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total radioactivity in blood, plasma urine and feces | Peak plasma concentration (Cmax) | Up to 168 hours |
| Total radioactivity in blood, plasma urine and feces | Area under the plasma concentration versus time curve (AUC) | Up to 168 hours |
| Total radioactivity in blood, plasma urine and feces | Time to reach Cmax (Tmax) | Up to 168 hours |
| Total radioactivity in blood, plasma urine and feces | Total radioactivity in urine and faeces at each time interval and cumulative radioactivity (mass balance) | Up to 168 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of HMS5552 and its metabolites in plasma, urine and feces | Peak plasma concentration (Cmax) | Up to 168 hours |
| Number of participants with adverse events as a measure of safety and tolerability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Tomek, MD | Celerion | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | United States |
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| ID | Term |
|---|---|
| C000629807 | Dorzagliatin |
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Adverse events; Laboratory parameters; Vital signs, clinical signs and symptoms and physical examination, including changes from baseline; ECG evaluation
| Up to 168 hours |
| Concentrations of HMS5552 and its metabolites in plasma, urine and feces | Area under the plasma concentration versus time curve (AUC) | Up to 168 hours |
| Concentrations of HMS5552 and its metabolites in plasma, urine and feces | Time to reach Cmax (Tmax) | Up to 168 hours |