A Study to Assess the Effect of Food on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to evaluate the PK of AMG 510 administered in the fasted and fed state in healthy participants.

Official Title
-----------------
An Open-label, Randomized, 2-period, 2-treatment Crossover Study to Assess the Effect of Food on the Pharmacokinetics of AMG 510 in Healthy Subjects

Conditions
-----------------
Healthy Participants

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male participants or female participants, 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
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Sequence AB<br>Participants will be administered AMG 510 orally in the following order: Period 1 (treatment A) - AMG 510 under fasted conditions. Period 2 (treatment B) - AMG 510 under fed conditions. | Drug: AMG 510<br>* Oral Tablet<br>* Other names: Sotorasib;|
| Experimental: Treatment Sequence BA<br>Participants will be administered AMG 510 orally in the following order: Period 1 (treatment B) - AMG 510 under fed conditions. Period 2 (treatment A) - AMG 510 under fasted conditions. | Drug: AMG 510<br>* Oral Tablet<br>* Other names: Sotorasib;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration (Cmax) of AMG 510 |  | Day 1 and Day 4 | 
| Area Under the Plasma Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of AMG 510 |  | Day 1 and Day 4 | 
| Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of AMG 510 |  | Day 1 and Day 4 | 

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 6 | 
| Cmax of AMG 510 Metabolite M24 |  | Day 1 and Day 4 | 
| AUClast of AMG 510 Metabolite M24 |  | Day 1 and Day 4 | 
| AUCinf of AMG 510 Metabolite M24 |  | Day 1 and Day 4 | 

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