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A Study of LY2409021 in Healthy Participants

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ClinicalTrials.gov Identifier: NCT02217618
Recruitment Status : Completed
First Posted : August 15, 2014
Results First Posted : October 29, 2018
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Participants Drug: LY2409021 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Single Dose Pharmacokinetic Study of LY2409021 Tablet Administered in Healthy Subjects
Study Start Date : August 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: LY2409021
Single oral dose of 20 milligrams (mg) LY2409021.
 Drug: LY2409021


Outcome Measures
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Primary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02217618


Locations
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United States, Florida
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
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02217618    
Other Study ID Numbers: 14580
I1R-MC-GLDL ( Other Identifier: Eli Lilly and Company )
First Posted: August 15, 2014    Key Record Dates
Results First Posted: October 29, 2018
Last Update Posted: October 29, 2018
Last Verified: March 2018