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To assess absorption, metabolism and excretion of [14C]-LXI-15028 in Chinese healthy male Subjects following a single oral dose of [14C]LXI-15028 suspension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]LXI-15028(n=6-8) | Experimental | Subjects will receive a single oral dose of [14C]LXI-15028 suspension under the fasted state . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]LXI-15028 | Drug | [14C]LXI-15028 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mass balance | Mass balance recovery of total radioactivity in urine and fecal samples | approximately 11 days |
| Metabolite Profiling | To provide plasma, urine and faecal samples for metabolite profiling and structural identification | approximately 11 days |
| Total radioactivity in plasma PK:Tmax | Time for Cmax | approximately 11 days |
| Total radioactivity in plasma PK:AUC0-t | Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration. | approximately 11 days |
| Total radioactivity in plasma PK:t1/2 | Elimination half-life. | approximately 11 days |
| Total radioactivity in plasma PK:CL/F | Drug clearance | approximately 11 days |
| Total radioactivity in plasma PK:Vd/F | Apparent volume of distribution following oral administration | approximately 11 days |
| LXI-15028 and metabolite PK:Cmax | Maximum plasma concentration | approximately 11 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Number of adverse events, which are any untoward medical occurrence regardless of attribution to study drug in a participant who received study drug | approximately 11 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liyan Miu | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40349123 | Derived | Bian Y, Yuan J, Ma S, Nan J, Gu Z, Feng H, Yu Z, Liu Z, Xie F, Wang Y, Liu C, Zhang H, Miao L. Mass balance and metabolite profiles in humans of tegoprazan, a novel potassium-competitive acid blocker, using 14C-radiolabelled techniques. Expert Opin Drug Metab Toxicol. 2025 Jul;21(7):897-907. doi: 10.1080/17425255.2025.2505637. Epub 2025 May 13. |
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| LXI-15028 and metabolite PK:Tmax | Time for Cmax | approximately 11 days |
| LXI-15028 and metabolite PK:AUC0-t | Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration. | approximately 11 days |
| LXI-15028 and metabolite PK:AUC0-inf | Area under the plasma concentration time profile from time 0 to infinity. | approximately 11 days |
| LXI-15028 and metabolite PK:t1/2 | Elimination half-life. | approximately 11 days |
| LXI-15028 and metabolite PK:CL/F | Drug clearance | approximately 11 days |
| LXI-15028 and metabolite PK:Vd/F | Apparent volume of distribution following oral administration | approximately 11 days |