Healthy
Conditions
Brief summary
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.
Interventions
DRUGMerestinib
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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prescription medications that alter gastric pH, at least 14 days prior to first dosing * Have previously completed or withdrawn from this study or any other study investigating merestinib, and have previously received the investigational product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed