A Study of LY2157299 in Healthy Participants

Healthy Volunteers Clinical Trial

Official title:

Effect of Food on the Pharmacokinetics of LY2157299 Monohydrate in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01965808
• Other study ID #: 15239
• Secondary ID: H9H-MC-JBAU
• Status: Completed
• Phase: Phase 1
• First received: October 16, 2013
• Last updated: December 3, 2013
• Start date: October 2013
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• LY2157299
Administered orally

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: Maximum Concentration (Cmax) of LY2157299		Pre-dose through 72 hours post-dose in each study period	No
Primary	Pharmacokinetics: Time of Maximum Observed Concentration (tmax) of LY2157299		Pre-dose through 72 hours post-dose in each study period	No
Primary	Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2157299		Pre-dose through 72 hours post-dose in each study period	No