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The primary objectives of this study are to evaluate the effect of AMG 510 on the pharmacokinetics (PK) of metformin in healthy participants and to evaluate the effect of metformin on the PK of AMG 510 in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 510 + Metformin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 510 | Drug | Oral tablet |
| |
| Metformin |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of Metformin | Day 1 and Day 8 | |
| Area Under the Plasma Concentration Time Curve (AUC) from Time Zero to the Last Quantifiable Concentration (AUClast) of Metformin | Day 1 and Day 8 | |
| AUC from Time Zero to Infinity (AUCinf) of Metformin | Day 1 and Day 8 | |
| Cmax of AMG 510 | Day 4 and Day 8 | |
| AUClast of AMG 510 | Day 4 and Day 8 | |
| AUCinf of AMG 510 | Day 4 and Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with an Adverse Event (AE) | Any clinically significant changes in clinical laboratory tests, 12-lead electrocardiograms and vital signs will be recorded as AEs. | Day 1 to Day 10 |
| Plasma Concentration of AMG 510 Metabolite M24 |
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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 | 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 |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Drug |
Oral tablet |
|
| Day 4 and Day 8 |
| Urine Concentration of Metformin | Day 1 and Day 8 |
| Cmax of Metformin | Day 4 and Day 8 |
| AUClast of Metformin | Day 4 and Day 8 |
| AUCinf of Metformin | Day 4 and Day 8 |
| Rate of Renal Clearance of Metformin | Day 4 and Day 8 |
| Area Under the Glucose Concentration-time Curve from Time 0 to 2 Hours After Glucose Administration (AUC0-2) | Day 1, Day 4 and Day 8 |