A Study of LY3023414 Formulations and the Effect of Food

Relative Bioavailability and the Effect of Food on the Bioavailability of LY3023414 in Healthy Subjects

The purpose of this study is to measure how much LY3023414 (a test formulation and a reference formulation) gets into the blood stream and how long it takes the body to get rid of it.

The study will also evaluate the effects of a high fat meal on LY3023414 compared to taking LY3023414 on an empty stomach. In addition, the tolerability of the study drug formulations will be evaluated. Information about any side effects that may occur will be collected.

This study includes 3 periods. Participants will be admitted to the clinical research unit (CRU) one day before dosing in each period. Total study duration is about 21 days, including follow-up. Screening may occur up to 30 days before the first dose of study drug.

This study is for research purposes only and is not intended to treat any medical conditions.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LY3023414 Reference Fasted; Drug: LY3023414 Test Fasted; Drug: LY3023414 Test Fed

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Covance Clinical Research Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy surgically sterile or postmenopausal females and sterile males
• Have a body mass index (BMI) between 18.5 and 32.0 kilograms per meter squared (kg/m²), inclusive at screening

Exclusion Criteria:

• Cannot be investigative site personnel directly affiliated with this study or their immediate families. Immediate family is defined as a spouse, biological or legal guardian, child, or sibling
• Cannot be Lilly employees
• Have known allergies to LY3023414, related compounds, or any components of the formulation
• Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
• Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
• Show evidence of hepatitis C and/or positive hepatitis C antibody
• Show evidence of hepatitis B and/or positive hepatitis B surface antigen

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY3023414 Reference Fasted; Single oral dose of LY3023414 (Reference) on day one fasting.	Drug: LY3023414 Reference Fasted; Administered Orally
Experimental: LY3023414 Test Fasted; Single oral dose of LY3023414 (Test) on day one fasting.	Drug: LY3023414 Test Fasted; Administered Orally
Experimental: LY3023414 Test Fed; Single oral dose of LY3023414 (Test) on day one after a meal.	Drug: LY3023414 Test Fed; Administered Orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics (PK): Area under the concentration versus time curve (AUC) from time zero to infinity (AUC[0-inf]) of LY3023414	Pre-dose through 2 days post-dose in each period
Pharmacokinetics (PK): Area under the concentration from time zero to time t, where t is the last time point with a measurable concentration (AUC [0-tlast]) of LY3023414	Pre-dose through 2 days post-dose in each period
Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of LY3023414	Pre-dose through 2 days post-dose in each period
Pharmacokinetics (PK): Observed time of maximum concentration (tmax)	Pre-dose through 2 days post-dose in each period

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: June 28, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (Estimate): June 29, 2016

Study Record Updates

• Last Update Posted (Estimate): November 4, 2016
• Last Update Submitted That Met QC Criteria: November 3, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 15696; I6A-EW-CBBB (Other Identifier: Eli Lilly and Company)