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

Relative Bioavailability and the Effect of Food on the Bioavailability of LY2801653 in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LY2801653

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Covance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

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 milliliter (mL) within the last month

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY2801653 Reference - Fasted; Single oral dose of LY2801653 (Reference Formulation) administered in fasted state in one of three study periods.	Drug: LY2801653; Administered orally
Experimental: LY2801653 Test - Fasted; Single oral dose of LY2801653 (Test Formulation) administered in fasted state in one of three study periods.	Drug: LY2801653; Administered orally
Experimental: LY2801653 Test - Fed; Single oral dose of LY2801653 (Test Formulation) administered with a high fat meal in one of three study periods.	Drug: LY2801653; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: February 23, 2015
• First Submitted That Met QC Criteria: February 23, 2015
• First Posted (Estimate): February 25, 2015

Study Record Updates

• Last Update Posted (Estimate): June 19, 2015
• Last Update Submitted That Met QC Criteria: June 18, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 15778; I3O-EW-JSBD (Other Identifier: Eli Lilly and Company)