Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
26 participants
INTERVENTIONAL
2017-01-15
2017-04-04
Brief Summary
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* If there are any differences in the way LY3202626 is handled by the body when taken in two different forms
* Whether a high fat meal affects the way the body handles LY3202626
* How well tolerated LY3202626 is
There are three (3) study periods for all participants. Participants will be admitted to the clinical research unit (CRU) each period and will be discharged from the CRU following the completion of 2 overnight stays and up to 36 hours after dosing with LY3202626.
The study will last about 50 days, not including screening.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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LY3202626 (R-Fasting)
Single oral dose of LY3202626 (R) capsule under fasting conditions.
LY3202626 (R-Fasting)
Administered orally
LY3202626 (T1-Fasting)
Single oral dose of LY3202626 (T1) tablet under fasting conditions.
LY3202626 (T1-Fasting)
Administered orally
LY3202626 (T1-Fed)
Single oral dose of LY3202626 (T1) following a high fat breakfast.
LY3202626 (T1-Fed)
Administered orally
Interventions
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LY3202626 (R-Fasting)
Administered orally
LY3202626 (T1-Fasting)
Administered orally
LY3202626 (T1-Fed)
Administered orally
Eligibility Criteria
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Inclusion Criteria
* Female participants must be of non-childbearing potential confirmed by medical history or menopause
* Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m²) inclusive, at screening
Exclusion Criteria
* Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
* Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed
* Have previously completed or withdrawn from this study or any other study investigating LY3202626, and have previously received the investigational product
* Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
* Have a history of head trauma with loss of consciousness within the last 5 years
* Have known or ongoing psychiatric disorders
21 Years
ALL
Yes
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Singapore, , Singapore
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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I7X-MC-LLCE
Identifier Type: OTHER
Identifier Source: secondary_id
15567
Identifier Type: -
Identifier Source: org_study_id
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