Phase 2 Study to Evaluate the Preliminary Performance of the C13-URA Breath Test Kit in Dyspeptic Subjects

Approximately equal numbers of subjects will be enrolled in each of the 2 groups (with normal gastric emptying, and with delayed gastric emptying (gastroparesis)) to complete at least 10 subjects per group.

The subjects will first have their gastric emptying rates investigated by scintigraphy using the Solid Test Meal containing 500 uCi 99mTc sulfur colloid at Visit 1. Second, the subjects will have their gastric emptying rates investigated by scintigraphy and 13C-uracil GEBT simultaneously using the Semi solid Test Meal containing 500 uCi 99mTc sulfur colloid and 100 mg of 13C-uracil, respectively, at Visit 2. A comparison will be made between the results obtained at Visits 1 and 2 along with a comparison of the data obtained during Visit 2 for evaluation of the 13C-uracil GEBT.

• 13C-uracil (Drug), also known as C13-URA: PO, the Semi-solid Test Meal containing 100 mg of 13C-uracil . Perform the Breath Test.
• 99mTc sulfur colloid (Drug), also known as Technetium Tc 99m Sulfur Colloid Injection: PO, the Solid Test Meal containing 500 uCi 99mTc sulfur colloid. Perform the Scintigraphy.

Primary outcomes

• Expired 13CO2 concentrations [6 hours]: Expired 13CO2 concentrations are obtained from breath test. The values will be calculated to Re(t)\[B\] semi-solid: remaining (%) of semi-solid test meal in stomach at t, t1/2\[B\] semi solid: half emptying time of semi-solid test meal , and tlag\[B\] semi-solid: lag time of semi-solid test meal.

Secondary outcomes

• Concentrations of 13C-uracil and its major metabolites in plasma and urine [6 hours]: PK parameters of 13C-uracil and its major metabolites, DHU and UPA, including AUCt, AUC∞, Cmax, tmax, λz, and t1/2,z, will be calculated based on plasma and urine concentration for 13C-uracil and its metabolites, and expired 13CO2-excretion, which calculated based on expired 13CO2 concentrations

Sex: All, ages: 21 Years to 65 Years

Inclusion Criteria:

* Body mass index \[range is 18.0 to 33.0 kg/m2
* Subjects with any upper GI symptoms
* Stable creatinine

Exclusion Criteria:

* History of known peptic ulcers or stomach cancer.
* History of stomach surgery or resection
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food or other substance, unless approved by the investigator
* History of alcoholism or drug abuse
* History or presence of clinically significant GI, cardiovascular, central nervous system, hepatic, or renal disease; or other conditions
* History of eating disorders
* History or presence of an abnormal ECG, which, in the opinion of the investigator, is clinically significant

• Kimiyoshi Sudoh, Study director, Otsuka Pharmaceutical Co., Ltd.