A Study of LY2409021 in Healthy Participants

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: LY2409021

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

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY2409021; Single oral dose of 20 milligrams (mg) LY2409021.	Drug: LY2409021

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021	Area under the concentration versus time curve from zero to infinity (AUC[0-inf]) of LY2409021 is presented.	Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose
Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021		Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose
Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax) of LY2409021		Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: August 13, 2014
• First Submitted That Met QC Criteria: August 13, 2014
• First Posted (Estimate): August 15, 2014

Study Record Updates

• Last Update Posted (Actual): October 29, 2018
• Last Update Submitted That Met QC Criteria: March 24, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 14580; I1R-MC-GLDL (Other Identifier: Eli Lilly and Company)