A Study to Evaluate the Relative Bioavailability of AMG 510 Administered as Tablets and as a Water Dispersion 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 pharmacokinetics (PK) of AMG 510 administered as 8 x 120-mg tablets and as water dispersion in healthy participants.

Official Title
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An Open-label, Randomized, 2-Period, 2-Treatment Crossover Study to Evaluate the Relative Bioavailability of AMG 510 Administered as Tablets and as a Water Dispersion in Healthy Subjects

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: AMG 510


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects or healthy female between 18 and 55 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: 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. Inability to swallow oral medication or history of malabsorption syndrome. Poor peripheral venous access. History of significant 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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
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 in the following order: Period 1 (treatment A) - AMG 510 as oral tablets. Period 2 (treatment B) - AMG 510 as tablets dispersed in water. | Drug: AMG 510<br>* Tablets<br>|
| Experimental: Treatment Sequence BA<br>Participants will be administered AMG 510 in the following order: Period 1 (treatment B) - AMG 510 as tablets dispersed in water. Period 2 (treatment A) - AMG 510 as oral tablets. | Drug: AMG 510<br>* Tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) of AMG 510 |  | Day 1 and Day 4 | 
| Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to Time of 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) | An AE is any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. Any clinically significant changes in clinical laboratory tests, 12-lead electrocardiograms and vital signs will be recorded as AEs . | Day 1 to Day 6 | 

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