Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2014-11-30
2015-04-30
Brief Summary
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The second purpose of the study is to evaluate the effect of LY2623091 on the amount of simvastatin (and possibly tadalafil) in the blood stream and how long the body takes to get rid of it.
The safety and tolerability of LY2623091 when given with itraconazole, simvastatin and diltiazem or tadalafil will be evaluated.
There will be three groups of participants in this study. Results from Groups 1 and 2 will be analyzed during the study to determine whether to enroll participants in Group 3 or 4. The study is expected to last up to 40 days from the first dose to follow-up (inclusive). Screening may occur up to 28 days prior to enrollment.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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LY2623091 (Group 1)
LY2623091 administered orally once on Day 1 of Period 1.
LY2623091
Administered orally
Itraconazole + LY2623091 (Group 1)
200 mg itraconazole administered orally twice daily on Day 1 of Period 2 and once daily on Days 2 - 20 of Period 2. Single oral dose of LY2623091 coadministered on Day 6 of Period 2.
LY2623091
Administered orally
Itraconazole
Administered orally
Simvastatin (Group 2)
20 mg simvastatin administered orally once daily on Day 1.
Simvastatin
Administered orally
LY2623091 + Simvastatin (Group 2)
LY2623091 administered orally once daily on Days 3 - 13. Single oral dose of 20 mg simvastatin coadministered on Day 12.
LY2623091
Administered orally
Simvastatin
Administered orally
Tadalafil (Group 3)
5 mg tadalafil administered on Day 1 of Period 1. Arm is contingent on interim results from Groups 1 and 2.
Tadalafil
Administered orally
Tadalafil + LY2623091 (Group 3)
LY2623091 administered orally once daily on Day 1 up to Day 15 of Period 2. 5 mg tadalafil co-administered once daily on Day 10 of Period 2. Arm is contingent on interim results from Groups 1 and 2.
LY2623091
Administered orally
Tadalafil
Administered orally
LY2623091 (Group 4)
LY2623091 administered orally once on Day 1 of Period 1. Arm is contingent on interim results from Groups 1 and 2.
LY2623091
Administered orally
Diltiazem + LY2623091 (Group 4)
240 mg diltiazem administered once daily on Days 1 to 13 of Period 2. Single oral dose of LY2623091 coadministered on Day 4 of Period 2. Arm is contingent on interim results from Groups 1 and 2.
LY2623091
Administered orally
Diltiazem
Administered orally
Interventions
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LY2623091
Administered orally
Itraconazole
Administered orally
Simvastatin
Administered orally
Tadalafil
Administered orally
Diltiazem
Administered orally
Eligibility Criteria
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Inclusion Criteria
* Have a body mass index (BMI) between 18 and 32.0 kilograms per square meter (kg/m\^2) inclusive, at screening
* Female participants must be of non-childbearing potential
Exclusion Criteria
18 Years
65 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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Covance Clinical Research Inc
Daytona Beach, Florida, United States
Countries
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Other Identifiers
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I7T-MC-RMAG
Identifier Type: OTHER
Identifier Source: secondary_id
15523
Identifier Type: -
Identifier Source: org_study_id
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