Study to Evaluate the Effect of AMG 510 on the Pharmacokinetics (PK) of Digoxin in Healthy Participants

Study Overview
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Brief Summary
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The primary objective of the study is to evaluate the PK of digoxin administered alone and in combination with AMG 510 in healthy participants.

Official Title
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An Open-label, Drug-drug Interaction Study to Evaluate the Effect of AMG 510 on the Pharmacokinetics of Digoxin, a P-glycoprotein Substrate, in Healthy Subjects

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: AMG 510
* Drug: Digoxin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects or female subjects, between 18 and 60 years of age (inclusive), at the time of Screening. Body mass index, between 18 and 30 kg/m2 (inclusive), at the time of Screening. Females of nonchildbearing potential. Exclusion Criteria: Inability to swallow oral medication or history of malabsorption syndrome. History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor. Poor peripheral venous access. History or evidence, at Screening or Check in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMG 510 + Digoxin<br>Participants will receive digoxin on Day 1 and both AMG 510 + digoxin on Day 7. | Drug: AMG 510<br>* Oral tablet<br>* Other names: Sotorasib;Drug: Digoxin<br>* Oral tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | Day 7 | 
| AUClast of AMG 510 Administered in Combination with Digoxin |  | Day 7 | 
| AUCinf of AMG 510 Administered in Combination with Digoxin |  | Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMG 510, Healthy Participants, Digoxin