A Study of LY3023414 Formulations and the Effect of Food

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY3023414 Reference Fasted; Drug: LY3023414 Test Fasted; Drug: LY3023414 Test Fed

Study type: Interventional

Funder types: Industry

Identifiers

NCT02818335

15696

I6A-EW-CBBB (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

LY3023414 Reference Fasted

Experimental group

Description:

Single oral dose of LY3023414 (Reference) on day one fasting.

Treatment:

Drug: LY3023414 Reference Fasted

LY3023414 Test Fasted

Experimental group

Description:

Single oral dose of LY3023414 (Test) on day one fasting.

Treatment:

Drug: LY3023414 Test Fasted

LY3023414 Test Fed

Experimental group

Description:

Single oral dose of LY3023414 (Test) on day one after a meal.

Treatment:

Drug: LY3023414 Test Fed