Trial of a Gastrin Receptor Antagonist in Barrett's Esophagus

Inclusion Criteria

• Age >= 18 years, with histologically confirmed diagnosis of Barrett's Esophagus without dysplasia
• Minimum of 1 cm circumferential Barrett's mucosa on endoscopy or at least 2 cm maximal contiguous extent of Barrett's mucosa
• Proton pump inhibitor use at least once daily for at least twelve months prior to enrolment, and stable dose of PPI for the three months before enrolment
• ECOG performance status ≤ 2 and Karnofsky ≥ 60%
• Normal organ and marrow function
• Use of adequate contraception during the study
• Willingness to comply with all treatment and follow up procedures
• Ability to understand and the willingness to sign a written informed consent document
• Up to date with all age appropriate cancer screening tests, as per American Cancer Society guidelines

Exclusion Criteria

• Histologically confirmed BE with high grade dysplasia, invasive carcinoma of the esophagus, low grade dysplasia
• Prior endoscopic therapy for BE
• History of esophageal or gastric surgery
• History of atrophic gastritis, pernicious anemia, or Zollinger-Ellison syndrome
• Participation in a trial of an investigational medicinal product within the previous 28 days
• Prolonged QTc interval >450 msec
• History of allergic reactions attributed to compounds of similar chemical composition to YF476
• History of baseline findings of: diabetes mellitus requiring insulin therapy; pancreatitis; hepatitis B, hepatitis C or HIV; malabsorption syndrome or inability to swallow or retain oral medicine; major surgery ≤ 28 days prior to enrollment; ECOG performance status ≥ 2; or another cancer within 3 years except for basal carcinoma of the skin or cervical carcinoma in situ; any clinically significant and uncontrolled major morbidity
• Certain medicines and herbal remedies taken during the 7 days before the start of study drug
• Has evidence of cancer at the time of enrolment, or has surveillance tests planned within 21 weeks after enrollment