Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of the study is to evaluate the PK of digoxin administered alone and in combination with AMG 510 in healthy participants.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 510 + Digoxin | Experimental | Participants will receive digoxin on Day 1 and both AMG 510 + digoxin on Day 7. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 510 | Drug | Oral tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of Digoxin Administered Alone | Day 1 | |
| Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of Last Quantifiable Concentration (AUClast) of Digoxin Administered Alone | Day 1 | |
| AUC from Time Zero to Infinity (AUCinf) of Digoxin Administered Alone | Day 1 | |
| Maximum Plasma Concentration (Cmax) of Digoxin Administered in Combination with AMG 510 | Day 7 | |
| AUClast of Digoxin Administered in Combination with AMG 510 | Day 7 | |
| AUCinf of Digoxin Administered in Combination with AMG 510 | Day 7 |
| 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 13 |
| Cmax of AMG 510 Administered in Combination with Digoxin |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit, Inc | Daytona Beach | Florida | 32117 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39777405 | Derived | Cardona P, Houk B. Impact of Sotorasib, a KRAS G12C Inhibitor, on the Pharmacokinetics and Therapeutic Window of Digoxin, a P-Glycoprotein Substrate. Clin Pharmacol Drug Dev. 2025 Apr;14(4):298-303. doi: 10.1002/cpdd.1501. Epub 2025 Jan 7. |
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
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.
Not provided
| ID | Term |
|---|---|
| C000706028 | sotorasib |
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Digoxin | Drug | Oral tablet |
|
| Day 7 |
| AUClast of AMG 510 Administered in Combination with Digoxin | Day 7 |
| AUCinf of AMG 510 Administered in Combination with Digoxin | Day 7 |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |