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OpenTrials
Completed

NCT Number: NCT01965808

A Study of LY2157299 in Healthy Participants

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.

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Key information

Conditions

Healthy Volunteers

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY2157299

Drug

Administered orally

Primary outcomes

  1. Pharmacokinetics: Maximum Concentration (Cmax) of LY2157299

    Time frame: Pre-dose through 72 hours post-dose in each study period

  2. Pharmacokinetics: Time of Maximum Observed Concentration (tmax) of LY2157299

    Time frame: Pre-dose through 72 hours post-dose in each study period

  3. Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2157299

    Time frame: Pre-dose through 72 hours post-dose in each study period

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 18, 2013
Registry last updated
Dec 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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