A Study of LY3023414 Formulations and the Effect of Food
Completed · Phase 1
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT02818335
- Run by
- Eli Lilly and Company
- People needed
- 30
- Starts
- 2016-07-01
- Expected to finish
- 2016-10-01
- Last updated by the study team
- 2016-11-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Covance Clinical Research Inc — Daytona Beach, Florida, United States
Full record on ClinicalTrials.gov
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