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The primary objectives of the study are: to characterize the primary route(s) of elimination of [14C]-AMG 510 and drug-related material, and estimate the overall recovery of radiolabeled material in healthy male participants after oral administration of [14C]-AMG 510, and to characterize the pharmacokinetic (PK) of total radioactivity and AMG 510 following a single oral dose of [14C]-AMG 510 in healthy male participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG510 | Experimental | Each participant will receive a single oral dose of AMG510 on Day 1 after an overnight fast. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 510 | Drug | Single oral dose of AMG510. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve (AUC) from time zero to infinity (AUCinf) | Day 1 to Day 14 | |
| AUC from time zero to the last quantifiable concentration (AUClast) | Day 1 to Day 14 | |
| Maximum observed concentration (Cmax) | Day 1 to Day 14 | |
| Time of Cmax (tmax) | Day 1 to Day 14 | |
| Apparent terminal elimination half-life (t1/2) | Day 1 to Day 14 | |
| Total clearance (AMG 510 only; CL/F) | Day 1 to Day 14 | |
| Volume of distribution (AMG 510 only; Vz/F) | Day 1 to Day 14 | |
| Plasma AMG 510 to total radioactivity ratio | Day 1 to Day 14 | |
| Whole blood to plasma total radioactivity ratio | Day 1 to Day 14 | |
| Amount (Aeu) of AMG510 excreted in urine | Day 1 to Day 14 | |
| Percentage (feu) of AMG510 excreted in urine | Day 1 to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolite profile of AMG 510 | Day 1 to Day 14 | |
| Identification of AMG 510 metabolites | Day 1 to Day 14 | |
| Incidence of adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit, Inc | Madison | Wisconsin | 53704 | United States |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
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| ID | Term |
|---|---|
| C000706028 | sotorasib |
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| Renal clearance (CLR) of AMG510 | Day 1 to Day 14 |
| Amount (Aef) of AMG510 excreted in feces | Day 1 to Day 14 |
| Percentage (fef) of AMG510 excreted in feces | Day 1 to Day 14 |
Adverse events will be graded by severity. Laboratory abnormalities (hematology, clinical chemistry, and urinalysis test results) will be recorded as adverse events, in addition to abnormalities in vital signs and physical examinations. |
| Up to approximately 6 weeks |
| QTc interval measured by 12-lead electrocardiogram (ECG) | Up to approximately 6 weeks |