A Study of LY3023414 Formulations and the Effect of Food

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3023414 Test Fasted; Drug: LY3023414 Test Fed; Drug: LY3023414 Reference Fasted

• Registration Number: NCT02818335
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-28
• Study First Submitted QC: 2016-06-28
• Study First Posted: 2016-06-29
• Study Start: 2016-07
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-03
• Last Update Posted: 2016-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LY3023414 Test Fasted	LY3023414 Test Fasted	Single oral dose of LY3023414 (Test) on day one fasting.
LY3023414 Test Fed	LY3023414 Test Fed	Single oral dose of LY3023414 (Test) on day one after a meal.
LY3023414 Reference Fasted	LY3023414 Reference Fasted	Single oral dose of LY3023414 (Reference) on day one fasting.

Primary Outcome Measures

Name	Time	Method
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): Observed time of maximum concentration (tmax)	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

Trial Locations

Locations (1)

Covance Clinical Research Inc; 🇺🇸 Daytona Beach, Florida, United States