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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003371-35 | EudraCT Number |
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The purpose of the study is to determine the absorption, metabolism, and excretion of [14C]-evobrutinib in healthy participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evobrutinib | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evobrutinib | Drug | Participants will receive a single, oral dose of evobrutinib under fasting conditions as a solution, which will contain [14C]-evobrutinib. |
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| Measure | Description | Time Frame |
|---|---|---|
| Total Radioactivity Recovery Rate of Evobrutinib, Total Radioactivity and its Metabolites | Pre-dose up to Day 35 post-dose | |
| Percentage Excretion of Evobrutinib, Total Radioactivity and its Metabolites in Urine and Feces | Pre-dose up to Day 35 post-dose | |
| Renal Clearance of Evobrutinib, Total Radioactivity and its Metabolites | Pre-dose up to Day 35 post-dose | |
| Maximum Observed Plasma Concentration (Cmax) of Total [14C] Radioactivity (Evobrutinib and Metabolites) | Pre-dose up to Day 35 post-dose | |
| Time to Reach Maximum Plasma Concentration (Tmax) of Total [14C] Radioactivity (Evobrutinib and Metabolites) | Pre-dose up to Day 35 post-dose | |
| Terminal Elimination Half-Life (t1/2) of Total [14C] Radioactivity (Evobrutinib and Metabolites) | Pre-dose up to Day 35 post-dose | |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Total [14C] Radioactivity (Evobrutinib and Metabolites) | Pre-dose up to Day 35 post-dose | |
| Maximum Observed Plasma Concentration (Cmax) of Evobrutinib | Pre-dose up to Day 35 post-dose | |
| Time to Reach Maximum Plasma Concentration (Tmax) of Evobrutinib | Pre-dose up to Day 35 post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and Electrocardiogram Findings | Number of participants with clinically significant abnormalities will be reported. | From time of first dose to end of study participation approximately at Day 37 |
| Occurrence of Treatment -emergent Adverse Events (TEAEs) and Serious TEAEs |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences | Groningen | 9728 NZ | Netherlands |
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| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| Medical Information Location Map - Med Info Contacts | View source |
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| ID | Term |
|---|---|
| C000632111 | evobrutinib |
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| Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Evobrutinib | Pre-dose up to Day 35 post-dose |
| Terminal Elimination Half-Life (t1/2) of Evobrutinib | Pre-dose up to Day 35 post-dose |
| Apparent Volume of Distribution During Terminal Phase (Vz/f) of Evobrutinib | Pre-dose up to Day 35 post-dose |
| Apparent Clearance (CL/f) of Evobrutinib | Pre-dose up to Day 35 post-dose |
| From time of first dose to end of study participation approximately at Day 37 |
| Occurrence of Treatment -emergent Adverse Events (TEAEs) and Serious TEAEs by Severity | From time of first dose to end of study participation approximately at Day 37 |