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
35 participants
INTERVENTIONAL
2016-02-29
2016-07-31
Brief Summary
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* The effect of single increasing doses of the study drug, abemaciclib, on healthy participants.
* The relationship between the amount of abemaciclib and the electrical tracing of the heart rhythm when abemaciclib is given.
* How much abemaciclib is found in the bloodstream and how long the body takes to get rid of it.
Information about any side effects that occur will be collected. The study will enroll two groups (cohorts) of participants. Each group will complete 4 study periods. This study is expected to last about 3 months. Screening may occur up to 28 days prior to enrollment. All participants will undergo a follow-up assessment approximately 21 days after administration of their final dose of study drug.
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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
SINGLE
Study Groups
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Abemaciclib
200 - 600 mg single increasing oral dose of abemaciclib on Day 1 of up to 3 study periods.
Abemaciclib
Administered orally
Placebo
Single oral dose of placebo on Day 1 of 1 study period.
Placebo
Administered orally
Loperamide
Cohort 2, only. 8 mg Loperamide given orally once in 1 of 4 study periods.
Loperamide
Administered orally
Loperamide + Abemaciclib
Cohort 2, only. 8 mg Loperamide co-administered with abemaciclib given orally once in up to 1 of 4 study periods.
Abemaciclib
Administered orally
Loperamide
Administered orally
Loperamide + Placebo
Cohort 2, only. 8 mg Loperamide co-administered with placebo given orally once in up to 1 of 4 study periods.
Placebo
Administered orally
Loperamide
Administered orally
Interventions
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Abemaciclib
Administered orally
Placebo
Administered orally
Loperamide
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male participants will be sterile
* Female participants must not be of childbearing potential
Exclusion Criteria
* Have an abnormality in the 12-lead electrocardiogram (ECG) including a Fridericia's corrected QT interval (QTcF) greater than 450 milliseconds (ms) (males) or greater than 470 ms (females)
* Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
* Have a gastrointestinal disorder causing clinically significant symptoms such as nausea, vomiting, and diarrhea, or malabsorption syndromes, or constipation
Additional Exclusion Criterion for Participants Enrolled in Cohort 2:
* Have a known hypersensitivity to loperamide hydrochloride or to any of the excipients
18 Years
70 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 Unit
Daytona Beach, Florida, United States
Covance Clinical Research Unit
Evansville, Indiana, United States
Countries
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Other Identifiers
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I3Y-MC-JPCA
Identifier Type: OTHER
Identifier Source: secondary_id
16080
Identifier Type: -
Identifier Source: org_study_id
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