A Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets

Study Overview
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Brief Summary
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The primary objective of the study is to compare the pharmacokinetics (PK) of sotorasib administered orally as 1 tablet under fasted conditions to sotorasib administered orally as 2 tablets under fasted conditions.

Official Title
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An Open-label, Randomized, Crossover Study in Healthy Volunteers to Compare the Pharmacokinetics of Sotorasib Administered as 1 or 2 Tablets

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: Sotorasib


Participation Criteria
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Eligibility Criteria
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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/m^2 (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, including history of myolysis, not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to participants 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Sequence ABC<br>Participants will be administered sotorasib orally in the following order: Period 1 - as 1 tablet (test 1) Period 2 - as 2 tablets (reference) Period 3 - as 1 tablet (test 2) | Drug: Sotorasib<br>* Oral Tablet<br>* Other names: AMG 510;|
| Experimental: Treatment Sequence BAC<br>Participants will be administered sotorasib orally in the following order: Period 1 - as 2 tablets (reference) Period 2 - as 1 tablet (test 1) Period 3 - as 1 tablet (test 2) | Drug: Sotorasib<br>* Oral Tablet<br>* Other names: AMG 510;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Period 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Sotorasib |  | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on the 1st day of each period (Days 1 and 4) | 
| Period 1 and 2: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast) of Sotorasib |  | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on the 1st day of each period (Days 1 and 4) | 
| Period 1 and 2: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) of Sotorasib |  | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on on the 1st day of each period (Days 1 and 4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE) | A TEAE was defined as an adverse event (AE) that started during or after dosing, or started prior to dosing and increased in severity after dosing within each period. Clinically significant laboratory tests, 12-lead electrocardiogram (ECG), or vital sign results as assessed by the Investigator were also recorded as adverse events. | Day 1 to Day 9 | 
| Period 3: Cmax of Sotorasib |  | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on the 1st day of Period 3 (Day 7) | 
| Period 3: AUClast of Sotorasib |  | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on on the 1st day of Period 3 (Day 7) | 
| Period 3: AUCinf of Sotorasib |  | Predose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on the 1st day of Period 3 (Day 7) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sotorasib, AMG 510