The purpose of this study is to assess the pharmacodynamic effects (gastric emptying), safety, tolerability, and pharmacokinetics of single doses of GSK962040 in Type 1 diabetic patients with gastroparesis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
11
GSK Investigational Site
Leuven, Belgium
GSK Investigational Site
Stockholm, Sweden
Gastric emptying, as measured by the 13C octanoic acid breath test (Gastric half emptying time (t1/2b), Duration of the lag time (tlag), Gastric evacuation coefficient (GEC))
Time frame: 1.5 h post dose to 5.5 h post dose
Safety and tolerability of GSK962040 (Change from baseline and number of patients outside the normal range for blood pressure, heart rate, 12-lead ECG parameters)
Time frame: 2 h post dose
Pharmacokinetic parameters of GSK962040: Cmax, Tmax, AUC(0-t), AUC(0-inf) for single-dose, CL/F, V/F, and, if possible, half-life
Time frame: 24 h post dose
Safety and tolerability of GSK962040 (Adverse events)
Time frame: 6 weeks
Safety and tolerability of GSK962040 (Change from baseline in clinical chemistry and hematology parameters)
Time frame: 24 h post dose
Bowel movement parameters (Time to first bowel movement after first dose, Bowel movement count, Stool consistency (Bristol Stool Form scale))
Time frame: 24 h post dose
PK/PD relationship of PP, plasma glucagon, GLP-1, and ghrelin after a single dose of GSK962040.
Time frame: 0-6 h post dose
Plasma glucose
Time frame: 24 h post dose
Food intake
Time frame: 24 h post dose
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125 mg