A Study of LY2409021 Formulations in Healthy Participants



Status:Terminated
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 85
Updated:10/31/2018
Start Date:March 2015
End Date:May 2015

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Trial Summary
Trial Overview
Inclusion Criteria

A Single Dose Pharmacokinetic Study of LY2409021 in Healthy Subjects to Bridge Formulations From Capsules to Commercial Tablets

The purpose of this study is to measure how much of the new LY2409021 tablet formulations get
into the blood stream and how long it takes the body to get rid of them, compared to the
current LY2409021 capsule formulation. In addition, the safety and tolerability of both the
new and current formulations will be evaluated. Information about any side effects that may
occur will also be collected. The study has two parts. Each participant may enroll in one
part only. The study will last up to 8 weeks for each participant. Screening is required
prior to the start of the study.


Inclusion Criteria:

- Overtly healthy males or surgically sterile or postmenopausal females, as determined
by medical history and physical examination

- Have a body mass index (BMI) of 18.0 to 32.0 kilogram per square meter (kg/m^2)

- Have clinical laboratory test results within normal reference range for the population
or investigator site, or results with acceptable deviations that are judged to be not
clinically significant by the investigator

Exclusion Criteria:

- Have known allergies to LY2409021, related compounds or any components of the
formulation, or history of significant atopy

- Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the
investigator, increases the risks associated with participating in the study

- Have known or ongoing psychiatric disorders
We found this trial at
1
site
Covance Cru Inc
Daytona Beach, Florida 32117
?
mi
from
Daytona Beach, FL
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