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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000822-50 | EudraCT Number |
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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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This study will assess absorption, metabolism, and excretion of Radioactively Labeled Etrumadenant in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-etrumadenant | Experimental | Participants will receive a single dose of [14C]-etrumadenant. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-etrumadenant | Drug | Administered as specified in the treatment arm. |
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| Measure | Description | Time Frame |
|---|---|---|
| Excretion of total radioactivity in urine | Up to 25 days | |
| Excretion of total radioactivity in feces | Up to 25 days | |
| Percentage of total radioactivity in urine at selected time points | Up to 25 days | |
| Percentage of total radioactivity in feces at selected time points | Up to 25 days | |
| Mass balance recovery of total radioactivity in urine | Up to 25 days | |
| Mass balance recovery of total radioactivy in feces | Up to 25 days | |
| Number of Participants with Treatment Emergent Adverse Events (TEAEs) | Up to 38 days | |
| Number of participants with abnormal electrocardiogram (ECG) readings, abnormal vital signs, abnormal physical examinations and abnormal clinical laboratory tests results | Up to 38 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of total radioactivity in blood | Up to 24 days | |
| Percentage of total radioactivity in plasma | Up to 24 days | |
| Maximum Observed Plasma Concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Arcus Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences (PRA) - Early Development Services (EDS) | Groningen | NZ | 9728 | Netherlands |
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| Label | URL |
|---|---|
| ARC-19 - Lay Summary (English Version) | View source |
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Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan [SAP], Clinical Study Report [CSR]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
For more information, please visit our website.
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| Up to 25 days |
| Time to Cmax (Tmax) | Up to 25 days |
| Area Under the Curve From 0 to Last Observed Non-zero Concentration (AUC [0-Last]) | Up to 25 days |
| Area Under the Curve From Time '0' Extrapolated to Infinity (AUC[0-inf]) | Up to 25 days |
| Elimination Half-life (t1/2) | Up to 25 days |