This study is the first study in humans to assess the safety and tolerability of various doses of GSK1292263 alone, and taken with sitigliptan.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
76
GSK investigational product or placebo
Ascending dose based on target exposures or placebo
An ascending dose based on target exposure
GSK Investigational Site
Minneapolis, Minnesota, United States
Safety and tolerability parameters including adverse events, clinical laboratory, electrocardiogram, and vital signs assessments.
Time frame: Up to 4 days
Pharmacokinetic parameters, maximum observed plasma drug concentration, time to maximum observe.
Time frame: Up to 4 days
Pharmacodynamic endpoints
Time frame: Up to four days.
• Pharmacokinetic parameters following a dose, with and without food, and bioavailability
Time frame: Up to four days.
Relationships betwen drug exposures and pharmacodynamic parameters, safety, and tolerability, as appropriate.
Time frame: Up to four days.
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An ascending dose based on target exposures.
An ascending dose based on target exposure