A Study of LY2157299 in Healthy Participants
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: LY2157299 (Fasted) Single dose of 150 mg LY2157299 administered orally in fasted state in one of two study periods. |
Drug: LY2157299
Administered orally
|
Experimental: LY2157299 (Fed) Single dose of 150 mg LY2157299 administered orally in fed state in one of two study periods. |
Drug: LY2157299
Administered orally
|
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Daytona Beach | Florida | United States | 31227 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 15239
- H9H-MC-JBAU