Healthy
Conditions
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.
Interventions
DRUGLY3023414 Reference Fasted
Administered Orally
DRUGLY3023414 Test Fasted
Administered Orally
DRUGLY3023414 Test Fed
Administered Orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Maximum observed drug concentration (Cmax) of LY3023414 | Pre-dose through 2 days post-dose in each period |
| 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): Observed time of maximum concentration (tmax) | Pre-dose through 2 days post-dose in each period |
Countries
United States
Outcome results
None listed