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The main objective of this study is to determine the mass balance, routes of elimination, and pharmacokinetics of [14C]-BGB-11417 in healthy male participants along with determining the concentrations of radioactivity in plasma, fecal and urinary elimination of total radioactivity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C] radiolabeled BGB-11417 | Experimental | Participants will receive a single dose of [14C]-BGB-11417 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-BGB-11417 | Drug | A single oral dose of liquid formulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of BGB-11417 | From 0 to 168 hours after study drug administration | |
| Maximum concentration (Cmax) of BGB-11417 in Plasma | From 0 to 168 hours after study drug administration | |
| Time to Cmax (Tmax) of BGB-11417 in Plasma | From 0 to 168 hours after study drug administration | |
| Amount of BGB-11417-106 excreted (Ae) and Cumulative amount of BGB-11417-106 (Cum Ae) excreted in urine and feces | From 0 to 168 hours after study drug administration | |
| Percentage (%Fe) and cumulative percentage (Cum %Fe) of BGB-11417 or radioactive dose excreted in urine and feces | From 0 to 168 hours after study drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From the day of screening until end of study (approximately 1 month) |
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Inclusion Criteria:
Exclusion Criteria: -
Note: Other inclusion/exclusion criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ppd Development, Lp | Austin | Texas | 78744-1645 | United States |
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