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Completed

NCT Number: NCT02217618

A Study of LY2409021 in Healthy Participants

The study involves a single dose of LY2409021 taken by mouth. The purpose of this study is to determine how much LY2409021 enters the bloodstream and how long the body takes to get rid of the drug after the dose. This study will last approximately 28 days, not including screening. Screening can occur within 30 days prior to the start of the study.

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Key information

Conditions

Healthy Participants

Age range

18 year–85 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, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy males or females as determined by medical history
  • Satisfactory clinical laboratory and physical examination tests
  • Have a body mass index (BMI) of 18 to 32.0 kilograms per meter squared (kg/m^2)

Exclusion criteria

  • Abnormal electrocardiograms (ECGs)

Treatment and study plan

LY2409021

Drug

Primary outcomes

  1. Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021

    Time frame: Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose

    Area under the concentration versus time curve from zero to infinity (AUC[0-inf]) of LY2409021 is presented.

  2. Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021

    Time frame: Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose

  3. Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax) of LY2409021

    Time frame: Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Single Dose Pharmacokinetic Study of LY2409021 Tablet Administered in Healthy Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 15, 2014
Registry last updated
Oct 29, 2018

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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