A Study of LY2409021 in Healthy Participants
A Single Dose Pharmacokinetic Study of LY2409021 Tablet Administered in Healthy Subjects
2 other identifiers
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2014
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 13, 2014
CompletedFirst Posted
Study publicly available on registry
August 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedResults Posted
Study results publicly available
October 29, 2018
CompletedOctober 29, 2018
March 1, 2018
1 month
August 13, 2014
March 24, 2018
March 24, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (1)
LY2409021
EXPERIMENTALSingle oral dose of 20 milligrams (mg) LY2409021.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- \- Abnormal electrocardiograms (ECGs)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
MeSH Terms
Interventions
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2014
First Posted
August 15, 2014
Study Start
August 1, 2014
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
October 29, 2018
Results First Posted
October 29, 2018
Record last verified: 2018-03