drugset / Trial / NCT01301092

A Study to Compare the Concentrations of LY2189265 After Different Methods of Administration to Healthy Volunteers.

NCT01301092

Phase 1 Completed 30 enrolled Eli Lilly and Company
RandomizedCrossoverOpen-labelTreatment

Summary

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.

Timeline

Start
2011-02
Primary completion
2011-08
Completion
2011-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Dulaglutide Peptide 0.05 mg Intravenous
Subject Dulaglutide Peptide 0.1 mg Intravenous
Subject Dulaglutide Peptide 0.2 mg Intravenous
Subject Dulaglutide Peptide 0.75 mg Intravenous
Subject Dulaglutide Peptide 1.5 mg Intravenous