A Study of Merestinib (LY2801653) in Healthy Participants

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of food on merestinib (standard meal and high-fat meal) compared to the fasted state. The study will also measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. In addition, the tolerability of the study drug will be evaluated. Information about any side effects that may occur will also be collected. The study will last approximately 28 days. Screening is required within 28 days prior to the start of the study.

Official Title
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The Effect of Food on the Bioavailability of Merestinib in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Merestinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Generally healthy sterile male and female participants Body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive Are willing and able to eat the protocol specified high-fat breakfast Exclusion Criteria: Have consumed grapefruits or grapefruit-containing products, Seville oranges or Seville orange juice, star fruit, star fruit juice, or star fruit-containing products, or commercial apple or orange juice within 14 days prior to first dosing Regularly use known drugs of abuse and/or show positive findings on urinary drug screening Have donated blood of more than 500 milliliters (mL) within the last month Cannot stop taking over-the-counter (OTC) or prescription medications that alter gastric pH, at least 14 days prior to first dosing Have previously completed or withdrawn from this study or any other study investigating merestinib, and have previously received the investigational product

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Merestinib Fasted<br>Single dose of merestinib administered in fasted state in one of three periods | Drug: Merestinib<br>* Administered orally<br>* Other names: LY2801653;|
| Experimental: Merestinib Standard Meal<br>Single dose of merestinib administered with a standard meal in one of three periods | Drug: Merestinib<br>* Administered orally<br>* Other names: LY2801653;|
| Experimental: Merestinib High-Fat Meal<br>Single dose of merestinib administered with a high-fat meal in one of three periods | Drug: Merestinib<br>* Administered orally<br>* Other names: LY2801653;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) for Merestinib for High-Fat Meal and Fasted State |  | Predose through 120 hours after administration of study drug | 
| Pharmacokinetics: Maximum Concentration (Cmax) for Merestinib for Standard Meal and Fasted State |  | Predose through 120 hours after administration of study drug | 
| Pharmacokinetics: Area Under The Concentration Curve AUC(0-∞) for Merestinib for High-Fat Meal and Fasted State |  | Predose through 120 hours after administration of study drug | 
| Pharmacokinetics: Area Under The Concentration Curve AUC(0-∞) for Merestinib for Standard Meal and Fasted State |  | Predose through 120 hours after administration of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Maximum Concentration (Cmax) for Metabolites (M1 and M2) for High-Fat Meal and Fasted State |  | Predose through 120 hours after administration of study drug | 
| Pharmacokinetics: Maximum Concentration (Cmax) for Metabolites (M1 and M2) for Standard Meal and Fasted State |  | Predose through 120 hours after administration of study drug | 
| Pharmacokinetics: Area Under the Concentration Curve AUC(0-∞) for Metabolites (M1 and M2) for High-Fat Meal and Fasted State |  | Predose through 120 hours after administration of study drug | 
| Pharmacokinetics: Area Under the Concentration Curve AUC(0-∞) for Metabolites (M1 and M2) for Standard Meal and Fasted State |  | Predose through 120 hours after administration of study drug |