NCT02779738

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 29, 2016

Status Verified

August 1, 2016

Enrollment Period

3 months

First QC Date

May 19, 2016

Last Update Submit

August 25, 2016

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

Secondary Outcomes (4)

  • 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

Study Arms (3)

Merestinib Fasted

EXPERIMENTAL

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

Drug: Merestinib

Merestinib Standard Meal

EXPERIMENTAL

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

Drug: Merestinib

Merestinib High-Fat Meal

EXPERIMENTAL

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

Drug: Merestinib

Interventions

MerestinibDRUG

Administered orally

Also known as: LY2801653
Merestinib FastedMerestinib High-Fat MealMerestinib Standard Meal

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Inc

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Interventions

merestinib

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2016

First Posted

May 20, 2016

Study Start

May 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 29, 2016

Record last verified: 2016-08

Locations

US(1)