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This study is a single-center, open-label, single-dose clinical pharmacokinetic study. The purpose of this study is to investigate the absorption characteristics, as well as to evaluate the metabolism and elimination pathways after a single oral dose of 150mg, 100μCi [14C]LP-168 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]LP-168 | Experimental | Using 14C-labeled LP-168 as a marker to investigate the absorption characteristic, as well as to evaluate the metabolism and elimination pathways in healthy subjects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]LP-168 | Drug | single dose of 150 mg/100 μCi [14C] LP-168, orally suspension at fasted state |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radioactivity concentration of blood and plasma sample | Use liquid scintillation counter to evaluate Radioactivity concentration of each sample | Day 1- Day 8 |
| Radioactivity concentration of urine and feces sample | Use liquid scintillation counter to evaluate Radioactivity concentration of each sample | Day 1- Day 15 |
| Number of metabolites and its proportion in plasma, urine and feces. | To study the metabolite profiling | Day 1- Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma LP-168/Major Metabolic concentrations | To determine the plasma concentrations of LP-168/Major Metabolic using LC-MS/MS. | Day 1- Day 8 |
| Treatment emergent adverse events as assessed by CTCAE 5.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liyan Miao, MD | 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 | 215000 | China |
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To evaluate the safety after the study intervention
| Day 1- Day 15 |