A Study of LY2801653 in Healthy Participants Who Are Not Able to Have Children

NCT02370485 | Completed Phase 1

• 2 other identifiers: 15778I3O-EW-JSBD
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate how much of the LY2801653 drug is available in the body when given in 2 different formulations with and without a meal to healthy participants who are not able to have children. In addition, this study will measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected. The study will last about 27 days. Screening is required within 28 days prior to the start of the study.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics: Maximum Concentration (Cmax) for LY2801653

  Predose through 96 hours after administration of study drug in periods 1 and 2 and predose through 120 hours after administration of study drug in period 3

• Pharmacokinetics: Area Under the Concentration Curve (AUC 0-∞) for LY2801653

  Predose through 96 hours after administration of study drug in periods 1 and 2 and predose through 120 hours after administration of study drug in period 3

Secondary Outcomes (2)

• Pharmacokinetics: Maximum Concentration (Cmax) of LY2801653 and Major Metabolites LSN2800870 and LSN2887652

  Predose through 96 hours after administration of study drug in periods 1 and 2 and predose through 120 hours after administration of study drug in period 3

• Pharmacokinetics: Area Under the Concentration Curve (AUC 0-∞) for LY2801653 and Major Metabolites LSN2800870 and LSN2887652

  Predose through 96 hours after administration of study drug in periods 1 and 2 and predose through 120 hours after administration of study drug in period 3

Study Arms (3)

LY2801653 Reference - Fasted

EXPERIMENTAL

Single oral dose of LY2801653 (Reference Formulation) administered in fasted state in one of three study periods.

Drug: LY2801653

LY2801653 Test - Fasted

EXPERIMENTAL

Single oral dose of LY2801653 (Test Formulation) administered in fasted state in one of three study periods.

Drug: LY2801653

LY2801653 Test - Fed

EXPERIMENTAL

Single oral dose of LY2801653 (Test Formulation) administered with a high fat meal in one of three study periods.

Drug: LY2801653

Interventions

LY2801653 DRUG

Administered orally

LY2801653 Reference - Fasted; LY2801653 Test - Fasted; LY2801653 Test - Fed

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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/m\^2), 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 milliliter (mL) within the last month

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Covance

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
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: February 25, 2015
• Study Start: February 1, 2015
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 19, 2015

Record last verified: 2015-06

Locations

US (1)