A Study to Evaluate the Drug-drug Interaction Effect of Itraconazole on the Pharmacokinetics (PK) of AMG 510 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 pharmacokinetic (PK) profile of AMG 510 administered alone and in combination with itraconazole in healthy participants.

Official Title
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An Open-label Study to Evaluate the Drug-drug Interaction Effect of Itraconazole, a CYP3A4 Inhibitor, on the Pharmacokinetics of AMG 510 in Healthy Subjects

Conditions
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Healthy Participants

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


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 + Itraconazole<br> | Drug: AMG 510<br>* Oral tablet<br>Drug: Itraconazole<br>* Oral capsule<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 6 | 
| 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 6 | 
| AUC from Time Zero to Infinity (AUCinf) of AMG 510 |  | Day 1 and Day 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with an Adverse Event (AE) | An adverse event 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 8 | 
| Cmax of AMG 510 Metabolite M24 |  | Day 1 and Day 6 | 
| AUClast of AMG 510 Metabolite M24 |  | Day 1 and Day 6 | 
| AUCinf of AMG 510 Metabolite M24 |  | Day 1 and 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, Itraconazole