Dose Response of 28 Days of Dosing of GSK962040 in Type I and II Diabetic Male and Female Subjects With Gastroparesis

Inclusion Criteria

• •Type I or II Diabetes Mellitus (HbA1C \< 10%)
• •Male or female between 18 and 80 years of age, inclusive.
• •Patient has gastroparesis at screening (gastric half-time of emptying \> upper limit of normal as determined by 13C-oral breath test)
• •Patient must have a \> or = 3 month history of relevant symptoms of gastroparesis (e.g., chronic post-prandial fullness, early satiety, postprandial nausea), patients will have a mean of the daily scores over a minimum of 7 days indicating \> or = mild (2) and \< or = severe (4) post-prandial fullness assessed using the GCSI-DD during the screening period prior to randomization.
• •A female patient is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) \> 40 MlU/mL, or a value consistent with the local laboratory standard value, is confirmatory. OR Child-bearing potential and agrees to use one of the contraception methods listed in Section 8.1 for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female patients must agree to use contraception for at least 5 days following the last dose of study medication.
• •Male patients must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication through at least 5 days after the last dose of study medication.
• •BMI \>18 and \< or = 35.0 kg/m2 (inclusive).
• •Patient has never had a gastrectomy, nor major gastric surgical procedure or any evidence of bowel obstruction or strictures within the previous 12 months
• •Dosage of any concomitant medications has been stable for at least 3 weeks, except for routine adjustments in daily insulin treatments.
• •Estimated (or measured) glomerular filtration rate \> or = 30 mL/min.
• •QTcB or QTcF \< 450 msec or QTc \< 480 msec in patients with Bundle Branch Block based on single or average QTc value of triplicate values obtained over a brief recording period.
• •Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
• •AST and ALT \< 2xULN; alkaline phosphatase and bilirubin \< or = 1.5xULN (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).