LY2189265 is an investigational drug being developed for the treatment of type 2 diabetes mellitus. This study will compare the concentrations of LY2189265 using different methods of administration: subcutaneous (or SC- an injection just under the skin), intravenous (or IV - into a vein in the arm) and intramuscular (IM - into the muscle of the left thigh). The purpose of this study is to look at how much of the drug gets into the blood stream and how long it takes the body to get rid of it when given by the methods above. The study is divided into three parts, Part A, B and C. Volunteers will only be able to participate in one part. All Participants in Part A will receive a single IV dose of up to 0.1 milligram (mg). Participants in Part B will be given drug twice by IV and an SC injection (1.5 mg). Part B of the study will occur after Part A because the dose of IV drug will depend on the results of Part A. Part B of the study may not occur if the volunteers in Part A do not tolerate the drug. Participants in Part C will also be given drug twice by an SC injection and an IM injection, both doses will be 0.75 mg.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
administered intravenous, subcutaneous or intramuscular
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Evansville, Indiana, United States
Dose Normalized Area Under the Concentration Time Curve (AUC) of LY2189265: Subcutaneous (SC) to Intravenous (IV)
AUC is AUC from time zero to infinity. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.
Time frame: Predose up to 336 hours postdose
Maximum Concentration (Cmax) of LY2189265: Subcutaneous (SC) to Intravenous (IV)
The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.
Time frame: Predose up to 336 hours postdose
Area Under the Concentration Time Curve (AUC) of LY2189265: Intramuscular (IM) to Subcutaneous (SC)
AUC is AUC from time zero to infinity. The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.
Time frame: Predose up to 336 hours postdose
)Maximum Concentration (Cmax) of LY2189265: Intramuscular (IM) to Subcutaneous (SC)
The results presented are Geometric Least Squares (LS) Mean. LS Mean values were controlled for participants, sequence, treatment, period and random error.
Time frame: Predose up to 336 hours postdose
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