A Study of LY2605541 in Healthy Participants



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 65
Updated:10/21/2018
Start Date:June 2013
End Date:September 2013

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Assessment of the Impact of Monomethoxy Polyethylene Glycols on the Pharmacokinetics and Glucodynamics of Single Doses of LY2605541 in Healthy Subjects

This study looks at the amount of LY2605541 in the body after it is injected under the skin.
The study has 3 periods, each lasting 10 days. Each participant will receive one injection in
each period. At least 14 days will pass between each injection.


Inclusion Criteria:

- Are overtly healthy males or females, as determined by medical history and physical
examination

- A body mass index of 18.5 to 30 kilograms per meter square (kg/m^2)

Exclusion Criteria:

- 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; of
constituting a risk when taking the study medication; or of interfering with the
interpretation of data

- Are women with a positive pregnancy test or are women who are lactating

- Intend to use over-the-counter medication within 7 days prior to dosing or
prescription medication within 14 days prior to dosing (apart from contraceptive
medication, vitamin/mineral supplements, occasional acetaminophen, and/or hormone
replacement therapy)

- Have donated blood of more than 500 milliliters (mL) within the last month

- Have an average weekly alcohol intake that exceeds 21 units per week (for males) and
14 units per week (for females)

- Are excessive consumers of xanthines (more than 10 cups of tea, coffee, cola, or hot
chocolate per day)

- Have a fasting blood glucose (BG) >110 milligrams per deciliter (mg/dL) (6.1
millimoles per liter [mmol/L])

- Currently smoke more than 10 cigarettes per day, or are unwilling to refrain from
smoking for 72 hours prior to each dosing occasion and during confinement
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