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The purpose of this study is to determine the excretion kinetics and mass balance of fenebrutinib in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Oral Solution Dose | Experimental | Single 200-mg (approximately 100-µCi) oral solution dose of [14C/12C]-fenebrutinib under fasted conditions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fenebrutinib | Drug | 200-mg (100 µCi) oral solution 14C/12C]-fenebrutinib |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Percentage of the Total Radioactive Dose Administered Excreted from Urine and Feces"; TimeFrame: "Day 1 to end of study (approximately 35 days post-dose) | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any AE that can be fatal, life threatening, prolongs inpatient hospitalization, significant disability, congenital anamoly, is a significant medical event in the Investigator's judgment. | Screening to end of study (approximately 35 days post-dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of Fenebrutinib and its Metabolites | Day 1 pre-dose to end of study (approximately 35 days post-dose) | |
| Time to Observed Maximum Concentration (Tmax) of Fenebrutinib and its Metabolites | Day 1 pre-dose to end of study (approximately 35 days post-dose) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit, Inc | Madison | Wisconsin | 53704 | United States |
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| ID | Term |
|---|---|
| C000619415 | fenebrutinib |
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| Area Under the Concentration-Time Curve From Hour 0 to the Last Measurable Concentration (AUC0-t) of Fenebrutinib and its Metabolites | Day 1 pre-dose to end of study (approximately 35 days post-dose) |
| Area under the Concentration-Time Curve Extrapolated to Infinity (AUC0-infinity) of Fenebrutinib and its Metabolites | Day 1 pre-dose to end of study (approximately 35 days post-dose) |
| Cumulative Percent of Total Radioactivity Excreted in Urine Over the Sampling Interval (Total % Feu) | Day 1 pre-dose to end of study (approximately 35 days post-dose) |
| Cumulative Percent of Total Radioactivity Excreted in Feces Over the Sampling Interval (Total % Fef) | Day 1 pre-dose to end of study (approximately 35 days post-dose) |
| Number of Participants With Clinical Significant Changes in Vital Signs | Vital signs incudes oral temperature, respiratory rate, supine blood pressure and pulse. | Screening up to Day 31 |
| Number of Participants With Clinical Significant Changes in Physical Examination Findings | Physical examination will consist of an assessment of general appearance, skin, thorax/lungs, abdomen, lymph nodes, head, ears, eyes, nose, throat, neck (including thyroid); and cardiovascular, musculoskeletal, and neurological systems. | Day -1, 28 |
| Number of Participants With Clinical Significant Changes in Clinical Laboratory Results | Laboratory analysis include chemistry panel, complete blood count and urinalysis. | Screnning, Day -1, 2, 4, 28 |
| Number of Participants With Clinical Significant Changes in Electrocardiograms (ECGs) | Screening, Day-1, 1 (Pre-dose; 1, 3 hours [h] post-dose), 28, 31 |