Clinical trial NCT02779738: A Study of Merestinib (LY2801653) in Healthy Participants
Official title: The Effect of Food on the Bioavailability of Merestinib in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2016-05-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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* Have previously completed or withdrawn from this study or any other study investigating merestinib, and have previously received the investigational product

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) for Merestinib for High-Fat Meal and Fasted State
timeFrame: Predose through 120 hours after administration of study drug
measure: Pharmacokinetics: Maximum Concentration (Cmax) for Merestinib for Standard Meal and Fasted State
timeFrame: Predose through 120 hours after administration of study drug
measure: Pharmacokinetics: Area Under The Concentration Curve AUC(0-∞) for Merestinib for High-Fat Meal and Fasted State
timeFrame: Predose through 120 hours after administration of study drug
measure: Pharmacokinetics: Area Under The Concentration Curve AUC(0-∞) for Merestinib for Standard Meal and Fasted State
timeFrame: Predose through 120 hours after administration of study drug
Secondary outcomes:
measure: Pharmacokinetics: Maximum Concentration (Cmax) for Metabolites (M1 and M2) for High-Fat Meal and Fasted State
timeFrame: Predose through 120 hours after administration of study drug
measure: Pharmacokinetics: Maximum Concentration (Cmax) for Metabolites (M1 and M2) for Standard Meal and Fasted State
timeFrame: Predose through 120 hours after administration of study drug
measure: Pharmacokinetics: Area Under the Concentration Curve AUC(0-∞) for Metabolites (M1 and M2) for High-Fat Meal and Fasted State
timeFrame: Predose through 120 hours after administration of study drug
measure: Pharmacokinetics: Area Under the Concentration Curve AUC(0-∞) for Metabolites (M1 and M2) for Standard Meal and Fasted State
timeFrame: Predose through 120 hours after administration of study drug
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Covance Clinical Research Inc
state: Florida
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: