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This is an open-label, single-center study to evaluate the mass-balance and pharmacokinetics of GB491 in 4-8 healthy male subjects receiving a single oral 150mg dose of GB491 containing approximately 50 uCi of [14C]GB491. This study will help understand how the drug appears in the blood, urine, and feces after it is administered.
In addition, this study will also evaluate the safety of a single dose of [14C]GB491 when given to healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]GB491 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]GB491 | Drug | A single 150mg dose of GB491 containing approximately 50 uCi of [14C]GB491. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total radioactivity in plasma PK | To investigate the distribution ratio of total radioactivity in whole blood to plasma and pharmacokinetic characteristics of total radioactivity in plasma in healthy subjects after a single dose of [14C]GB491. | Up to 168 hours post dose |
| Total radioactivity in urine and fecal samples | Quantitative analysis of total radioactivity in urine or feces in healthy subjects after a single dose of [14C]GB491. | Up to 360 hours post dose |
| Metabolite G1T30 and other major matabolites (if applicable) | Identify the main metabolites in healthy subjects after oral administration of [14C]GB491 to determine the main biotransformation pathway | Up to 168 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative analysis of drug concentrations of GB491, metabolite G1T30 and other major metabolites (if applicable) in plasma | Up to 168 hours post dose | |
| Adverse events | The safety of healthy subjects after a single dose of [14C]GB491 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fang HOU, Master | Beijing GoBroad Boren Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing GoBroad Boren Hospital | Beijing | Beijing Municipality | 100070 | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Up to 360 hours post dose |
| D017437 |
| Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |