Randomized, placebo-controlled trial of YF476, a gastrin receptor antagonist, in Barrett’s esophagus (10-505; T-016) - Netazepide (YF476) in patients with Barrett's oesophagus; version 1

Trio Medicines Ltd0 个研究点目标入组 22 人开始时间: 2015年4月16日最近更新: 2020年4月6日

适应症

试验速览

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•BO patients, aged 18 years of age; histologically confirmed diagnosis of Barrett's oesophagus, without dysplasia; have taken a proton pump inhibitor (PPI) use at least once daily, for the past 12 months, and a stable dose of PPI for the past 3 months; otherwise in good health; up-to-date with all age-appropriate cancer screening tests and no cancer screening planned for the next 21 weeks; able to communicate with study personnel; reliable, willing, and likely to comply with the protocol; and willing to comply with the contraception requirements of the protocol, and consent to our informing their GP of their participation in the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 18
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 4

•We exclude participants who meet the following criteria:
•* histologically confirmed Barrett's oesophagus (BO) with dysplasia or cancer of the oesophagus; clinically relevant ECG findings; history of allergic reactions to medicines similar to YF476; have taken part in another clinical trial of an experimental medicine within the past 28 days; have taken certain medicines or herbal remedies during the 7 days before the start of the study; have a history of or baseline findings indicative of medical conditions related to gastrin, or medical conditions or procedures related to the gastro-intestinal system; have had any cancer (except non-invasive skin or cervical cancer) in the past 3 years; have had any other clinically significant disease — because they might increase the risk or confound the assessment of YF476; or
•* pregnant or breastfeeding; unwilling to comply with the contraception requirements of the protocol — because of the potential risk to the unborn or breastfed baby.
•Those criteria are designed to select patients with BO who are otherwise healthy and robust enough to recover quickly from any adverse effects of YF476.

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