Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open-label, single dose, mass balance and biotransformation study conducted at 1 study center in China. This study will evaluate the absorption, distribution, metabolism, and elimination (ADME), mass balance, safety, and tolerability of a single dose of intravenously administered [14C]Iruplinalkib (WX-0593) in Chinese healthy male volunteers.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14]Iruplinalkib(WX-0593) 120 mg(orla solution) | Experimental | Volunteer will receive a single oral dose of 120 mg [14C]Iruplinalkib (WX-0593) administered by mouth, as a solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]Iruplinalkib (WX-0593) | Drug | Volunteer will receive a single oral dose of 120 mg [14C]Iruplinalkib (WX-0593) as a solution on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic profiling for iruplinalkib(WX-0593) will be determined in plasma samples. | Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces. | Assessments will be made up to 3 days post dose. |
| Metabolic profiling for iruplinalkib(WX-0593) will be determined in urine samples. | Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in urine. | Assessments will be made up to 3 days post dose. |
| metabolic profiling for iruplinalkib(WX-0593) will be determined in fecal samples. | Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in feces. | Assessments will be made up to 3 days post dose. |
| Total Radioactivity in Feces | Cumulative amount was calculated as sum of feces drug concentration in sample volume for each collection interval. | Assessments will be made up to 14 days post dose. |
| Total Radioactivity in Urine | Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. | Assessments will be made up to 14 days post dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) | Assessments will be made up to 28 days post dose. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided