Healthy
Conditions
Brief summary
The purpose of this study is to evaluate how much of the LY2801653 drug is available in the body when given in 2 different formulations with and without a meal to healthy participants who are not able to have children. In addition, this study will measure how much of the drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected. The study will last about 27 days. Screening is required within 28 days prior to the start of the study.
Interventions
DRUGLY2801653
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Generally healthy sterile male and female participants * Body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m\^2), inclusive * Are willing and able to eat the protocol specified high-fat breakfast
Exclusion criteria
* Have consumed grapefruits or grapefruit-containing products, Seville oranges or Seville orange juice, star fruit, star fruit juice, or star fruit-containing products, or commercial apple or orange juice within 14 days prior to first dosing * Regularly use known drugs of abuse and/or show positive findings on urinary drug screening * Have donated blood of more than 500 milliliter (mL) within the last month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) for LY2801653 | Predose through 96 hours after administration of study drug in periods 1 and 2 and predose through 120 hours after administration of study drug in period 3 |
| Pharmacokinetics: Area Under the Concentration Curve (AUC 0-∞) for LY2801653 | Predose through 96 hours after administration of study drug in periods 1 and 2 and predose through 120 hours after administration of study drug in period 3 |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) of LY2801653 and Major Metabolites LSN2800870 and LSN2887652 | Predose through 96 hours after administration of study drug in periods 1 and 2 and predose through 120 hours after administration of study drug in period 3 |
| Pharmacokinetics: Area Under the Concentration Curve (AUC 0-∞) for LY2801653 and Major Metabolites LSN2800870 and LSN2887652 | Predose through 96 hours after administration of study drug in periods 1 and 2 and predose through 120 hours after administration of study drug in period 3 |
Countries
United States
Outcome results
None listed