A Study of LY2409021 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: LY2409021

• Registration Number: NCT02217618
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-13
• Study First Submitted QC: 2014-08-13
• Study First Posted: 2014-08-15
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2018-03
• Results First Submitted: 2018-03-24
• Results First Submitted QC: 2018-03-24
• Last Update Submitted: 2018-03-24
• Results First Posted: 2018-10-29
• Last Update Posted: 2018-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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)

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Exclusion Criteria

• Abnormal electrocardiograms (ECGs)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LY2409021	LY2409021	Single oral dose of 20 milligrams (mg) LY2409021.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021	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.
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

Trial Locations

Locations (1)

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