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

Otsuka Pharmaceutical Co., Ltd.20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Dyspeptic Subjects

Interventions

13C-uracilDRUG

PO, the Semi-solid Test Meal containing 100 mg of 13C-uracil . Perform the Breath Test.

99mTc sulfur colloidDRUG

PO, the Solid Test Meal containing 500 uCi 99mTc sulfur colloid. Perform the Scintigraphy.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (2)

Compass Research

Orlando, Florida, United States

Dartmouth-Hitchcock Medical Center, Gastroenterology and Hepatology

Lebanon, New Hampshire, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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