A Phase 2 interventional study of 13C-uracil and 99mTc sulfur colloid in Dyspeptic Subjects, sponsored by Otsuka Pharmaceutical Co., Ltd.. Completed at 2 sites in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-04-08.
Sponsored by Otsuka Pharmaceutical Co., Ltd. · Phase 2, Interventional, and Diagnostic
This study is a multi-center, open-label comparison study and aimed to evaluate the preliminary performance of this 13C-uracil GEBT to examine its abilities of identifying abnormal (delayed) gastric emptying rates in 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.
Otsuka Pharmaceutical Co., Ltd. is the lead sponsor of 140 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Subjects will consume the Semi-solid Test Meal containing 500 uCi 99mTc sulfur colloid and 100 mg of 13C-uracil.
Drug: 13C-uracil · Drug: 99mTc sulfur colloid
Subjects will consume the Solid Test Meal containing 500 uCi 99mTc sulfur colloid.
Drug: 99mTc sulfur colloid
PO, the Semi-solid Test Meal containing 100 mg of 13C-uracil . Perform the Breath Test.
Also known as: C13-URA
PO, the Solid Test Meal containing 500 uCi 99mTc sulfur colloid. Perform the Scintigraphy.
Also known as: Technetium Tc 99m Sulfur Colloid Injection
Expired 13CO2 concentrations
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.
Time frame: 6 hours
Concentrations of 13C-uracil and its major metabolites in plasma and urine
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
Time frame: 6 hours
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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Otsuka Pharmaceutical Co., Ltd.