A Study of LY2157299 in Healthy Participants
Effect of Food on the Pharmacokinetics of LY2157299 Monohydrate in Healthy Subjects
2 other identifiers
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy-volunteers
Started Oct 2013
Shorter than P25 for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 16, 2013
CompletedFirst Posted
Study publicly available on registry
October 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedDecember 4, 2013
December 1, 2013
1 month
October 16, 2013
December 3, 2013
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
LY2157299 (Fasted)
EXPERIMENTALSingle dose of 150 mg LY2157299 administered orally in fasted state in one of two study periods.
LY2157299 (Fed)
EXPERIMENTALSingle dose of 150 mg LY2157299 administered orally in fed state in one of two study periods.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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, 31227, United States
MeSH Terms
Interventions
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2013
First Posted
October 18, 2013
Study Start
October 1, 2013
Primary Completion
November 1, 2013
Study Completion
December 1, 2013
Last Updated
December 4, 2013
Record last verified: 2013-12