A Study of Merestinib (LY2801653) in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-08-31

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Merestinib Fasted

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

Group Type EXPERIMENTAL

Merestinib

Intervention Type DRUG

Administered orally

Merestinib Standard Meal

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

Group Type EXPERIMENTAL

Merestinib

Intervention Type DRUG

Administered orally

Merestinib High-Fat Meal

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

Group Type EXPERIMENTAL

Merestinib

Intervention Type DRUG

Administered orally

Interventions

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Merestinib

Administered orally

Intervention Type DRUG

Other Intervention Names

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LY2801653

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes