A Drug-Drug Interaction Study of Lanabecestat (LY3314814) in Healthy Participants



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 65
Updated:3/24/2019
Start Date:April 2015
End Date:August 2015

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A Study to Characterize LY3314814 Pharmacokinetics as a Function of Dosing Duration and to Determine the Effect of LY3314814 on the Pharmacokinetics of CYP3A Substrates in Healthy Subjects

The purpose of this study is to study the effect of lanabecestat on how the body absorbs and
processes 3 other medications, midazolam, simvastatin and donepezil and how these 3
medications affect lanabecestat when they are taken together. This study is in 2 cohorts,
Cohort A is approximately 44 days long and Cohort B about 70 days only. The screening visit
is required within 30 days prior to the start on the study

Astra Zeneca (AZ) registered this trial as sponsor. In July, 2015, sponsorship changed to Eli
Lilly and Company (Lilly). In August, 2015, AZ transferred this trial to Lilly's
ClinicalTrials.gov account and Lilly updated the record. This trial is not an applicable
trial under the Food and Drug Administration Amendments Act of 2007 (FDAAA).

Inclusion Criteria:

- Overtly healthy and either sterile or, male and prepared to use an approved method of
contraception

- Have a body mass index (BMI) at screening of 19.0 to 32.0 kilogram per square meter
(kg/m^2)

Exclusion Criteria:

- History of any clinically significant disease or disorder which, in the opinion of the
Investigator, may put the subject at risk because of participation in the study, may
influence the results, or may limit the subject's ability to participate in the study

- History or presence of gastrointestinal, hepatic or renal disease or any other
condition known to interfere with absorption, distribution, metabolism or excretion of
drugs

- History of previous or ongoing psychiatric disease/condition
We found this trial at
2
sites
Daytona Beach, Florida 32117
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Daytona Beach, FL
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Dallas, Texas 75247
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Dallas, TX
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