Effect of Coadministration of Sotorasib on the Pharmacokinetics of Rosuvastatin in Healthy Participants

Study Overview
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Brief Summary
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A study to determine the effect of sotorasib on the pharmacokinetics (PK) of rosuvastatin, and to assess the PK of rosuvastatin when administered alone, in healthy participants.

Official Title
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A Phase I, Open-label, Fixed Sequence Crossover Study to Investigate the Effect of Coadministration of Sotorasib on the Pharmacokinetics of Rosuvastatin, a Breast Cancer Resistance Protein Substrate, in Healthy Subjects

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: Rosuvastatin
* Drug: Sotorasib


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, including history of myolysis, 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
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosuvastatin alone<br> | Drug: Rosuvastatin<br>* Oral dose<br>|
| Experimental: Rosuvastatin + sotorasib<br> | Drug: Rosuvastatin<br>* Oral dose<br>Drug: Sotorasib<br>* Oral dose<br>* Other names: AMG 510;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) of Rosuvastatin | The pharmacokinetic (PK) parameters were determined using standard non-compartmental methods. | Predose (Hour 0), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours postdose following administration of rosuvastatin on Days 1 and 6 | 
| Area Under the Plasma Concentration-Time Curve (AUC) From Time Zero to Time of Last Quantifiable Concentration (AUClast) of Rosuvastatin | The PK parameters were determined using standard non-compartmental methods. | Predose (Hour 0), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours postdose following administration of rosuvastatin on Days 1 and 6 | 
| AUC From Time Zero to Infinity (AUCinf) of Rosuvastatin | The PK parameters were determined using standard non-compartmental methods. | Predose (Hour 0), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 120 hours postdose following administration of rosuvastatin on Days 1 and 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting Any Treatment-Emergent Adverse Events (TEAEs) | Any clinically significant changes in clinical laboratory tests, 12-lead electrocardiograms (ECGs), and vital signs results were recorded as AEs. | Day 1 to Day 41 | 
| Cmax of Sotorasib | The PK parameters were determined using standard non-compartmental methods. | Predose (Hour 0), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 6 | 
| AUClast of Sotorasib | The PK parameters were determined using standard non-compartmental methods. | Predose (Hour 0), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 6 | 
| AUCinf of Sotorasib | The PK parameters were determined using standard non-compartmental methods. | Predose (Hour 0), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours postdose following administration of sotorasib on Day 6 | 

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