A Study of Merestinib (LY2801653) in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Merestinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02779738

I3O-MC-JSBH (Other Identifier)

16439

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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• Have previously completed or withdrawn from this study or any other study investigating merestinib, and have previously received the investigational product

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Merestinib Fasted

Experimental group

Description:

Single dose of merestinib administered in fasted state in one of three periods

Treatment:

Drug: Merestinib

Merestinib Standard Meal

Experimental group

Description:

Single dose of merestinib administered with a standard meal in one of three periods

Treatment:

Drug: Merestinib

Merestinib High-Fat Meal

Experimental group

Description:

Single dose of merestinib administered with a high-fat meal in one of three periods

Treatment:

Drug: Merestinib