TR2-A: effect on stomach acid in healthy men, v1
Research type
Research Study
Full title
An open study of single-rising doses of TR2-A, a prodrug of the gastrin/CCK2 receptor antagonist, TR2, on ambulatory gastric pH in healthy subjects (15-027).
IRAS ID
193291
Contact name
Frans van den Berg
Contact email
Sponsor organisation
Trio Medicines Ltd
Eudract number
2015-004501-16
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
TR2-A is an experimental new medicine that’s being developed to treat disorders related to gastrin – a hormone (chemical messenger) that causes the stomach to make acid and promotes growth and repair of cells in the stomach lining. TR2-A is broken down inside the body to an active medicine, called TR2, which blocks gastrin. TR2 is also the main breakdown product of another experimental medicine, called netazepide. TR2-A and/or TR2 have been tested in 16 healthy men, and netazepide has been tested in 220 healthy volunteers and 20 patients with illnesses, related to too much gastrin.\n\nWe’ll test single doses of TR2-A in 10 healthy adult men, to find out its side effects and effects on stomach acid. We’ll also measure how much TR2-A and TR2 get into the bloodstream.\n\nParticipants will have up to 4 study sessions. In all 4 study sessions, we’ll measure how much stomach acid the participants produce. In the first study session, participants won’t take any study medicine, to see how much stomach acid they normally produce. In study sessions 2–4, each participant will take a single dose of TR2-A. They’ll take 100 mg of TR2-A in study session 2, and we’ll increase the dose in later sessions after reviewing the results of previous study sessions.\n\nParticipants will take up to about 9 weeks to finish the study, and make up to 6 visits to the ward: screening, follow–up, and up to 4 study sessions. In each study session they’ll stay on the ward for 2–3 nights. \n\nA pharmaceutical company (Trio Medicines Ltd) is paying for the study. \n\nThe study will take place at 1 centre in London.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
15/SC/0692
Date of REC Opinion
5 Jan 2016
REC opinion
Further Information Favourable Opinion