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Completed

NCT Number: NCT02779738

A Study of Merestinib (LY2801653) in Healthy Participants

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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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Inc

Daytona Beach, Florida, 32117, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • Have previously completed or withdrawn from this study or any other study investigating merestinib, and have previously received the investigational product

Treatment and study plan

Merestinib

Drug

Administered orally

Other names: LY2801653

Primary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) for Merestinib for High-Fat Meal and Fasted State

    Time frame: Predose through 120 hours after administration of study drug

  2. Pharmacokinetics: Maximum Concentration (Cmax) for Merestinib for Standard Meal and Fasted State

    Time frame: Predose through 120 hours after administration of study drug

  3. Pharmacokinetics: Area Under The Concentration Curve AUC(0-∞) for Merestinib for High-Fat Meal and Fasted State

    Time frame: Predose through 120 hours after administration of study drug

  4. Pharmacokinetics: Area Under The Concentration Curve AUC(0-∞) for Merestinib for Standard Meal and Fasted State

    Time frame: Predose through 120 hours after administration of study drug

Secondary outcomes

  1. Pharmacokinetics: Maximum Concentration (Cmax) for Metabolites (M1 and M2) for High-Fat Meal and Fasted State

    Time frame: Predose through 120 hours after administration of study drug

  2. Pharmacokinetics: Maximum Concentration (Cmax) for Metabolites (M1 and M2) for Standard Meal and Fasted State

    Time frame: Predose through 120 hours after administration of study drug

  3. Pharmacokinetics: Area Under the Concentration Curve AUC(0-∞) for Metabolites (M1 and M2) for High-Fat Meal and Fasted State

    Time frame: Predose through 120 hours after administration of study drug

  4. Pharmacokinetics: Area Under the Concentration Curve AUC(0-∞) for Metabolites (M1 and M2) for Standard Meal and Fasted State

    Time frame: Predose through 120 hours after administration of study drug

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 20, 2016
Registry last updated
Aug 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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