A Study of LY2157299 in Healthy Participants

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: LY2157299

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 31227
      • 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.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: October 16, 2013
• First Submitted That Met QC Criteria: October 16, 2013
• First Posted (Estimate): October 18, 2013

Study Record Updates

• Last Update Posted (Estimate): December 4, 2013
• Last Update Submitted That Met QC Criteria: December 3, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 15239; H9H-MC-JBAU (Other Identifier: Eli Lilly and Company)