This study is an open-label study in healthy volunteers and in patients with Type 2 Diabetes Mellitus to assess safety and tolerability parameters, the levels of GSK716155 in the bloodstream after a single dose given at different injection sites, and the impact this medication has on various substances in the blood. Assessments include ECGs, vital signs, repeat blood sampling and monitoring of any side effects.
An Open-Label, Randomized, Multi-Site Study to Assess the Pharmacokinetics of Single Subcutaneous Injections of 16mg and 64mg of GSK716155 Administered at Three Different Injection Sites in Adult Male and Female Subjects with Type 2 Diabetes and of Single Subcutaneous Injections of 16mg and 64mg of GSK716155 Administered in the Abdomen of Healthy, Normal Volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
GSK716155 will be available as lyophilize uniform cake in 10 milliliter (mL) clear glass vials with 20 millimeter (mm) closure. Subjects will administer dose of either 16mg or 64mg of GSK716155 via subcutaneous injection(s). For dose of 16 mg 1 injection of 0.62 mL will be administered and for dose of 64 mg 3 injections of 0.82 mL each will be administered.
GSK Investigational Site
Long Beach, California, United States
GSK Investigational Site
Walnut Creek, California, United States
GSK Investigational Site
Miramar, Florida, United States
GSK Investigational Site
Orlando, Florida, United States
Pharmacokinetic measurements for different injection sites after one dose.
Time frame: Pre-dose, 6, 24, 48, 96, 216, 312, 480, 672 and 984 hours
Pharmacodynamic measurements at three different times after one dose.
Time frame: Up to Day 29
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GSK Investigational Site
Morrisville, North Carolina, United States
GSK Investigational Site
San Antonio, Texas, United States