Healthy Volunteers
Conditions
Brief summary
Participants in this study will receive two oral doses of 150 milligram (mg) LY2157299 taken at least 4 days apart. One dose will be given without food. One dose will be given with a high fat meal. The study will evaluate the effect of a high fat meal on how much of the drug gets into the blood stream. Side effects will be documented. This study will last approximately 15 days not including screening. Screening is required within 30 days prior to the start of the study.
Interventions
DRUGLY2157299
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
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy sterile males or females * Are able to eat a high fat meal * No abnormal heart function or high blood pressure * No participation in a clinical trial within 30 days * No evidence of human deficiency virus (HIV), hepatitis C or hepatitis B
Exclusion criteria
* Have a clinically significant abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: Maximum Concentration (Cmax) of LY2157299 | Pre-dose through 72 hours post-dose in each study period |
| Pharmacokinetics: Time of Maximum Observed Concentration (tmax) of LY2157299 | Pre-dose through 72 hours post-dose in each study period |
| Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2157299 | Pre-dose through 72 hours post-dose in each study period |
Countries
United States
Outcome results
None listed