TR2 single dose study; version 1
Research type
Research Study
Full title
A double-blind, placebo-controlled study of single-rising doses of TR2, a gastrin/CCK2 receptor antagonist, on ambulatory gastric pH and pentagastrin-stimulated gastric acid secretion in healthy subjects. HMR Code: 14-022
IRAS ID
163229
Contact email
Sponsor organisation
Trio Medicines Ltd
Eudract number
2014-003495-22
Duration of Study in the UK
0 years, 5 months, 18 days
Research summary
TR2 is an experimental 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 blocks the effects of gastrin. It has never been given to humans before, but a very closely related experimental medicine has been given to 240 healthy volunteers or patients with illnesses caused by too much gastrin.\n\nWe’ll test single doses of TR2, in 10 healthy adult men, to find out its side effects, blood levels and effects on stomach acid. We’ll also investigate its breakdown products.\n\nParticipants will have up to 4 study sessions. In each session they’ll take 2 doses of TR2, separated by 48 h. Participants will take a low dose of TR2 in their first study session. We’ll increase the dose in later sessions after we’ve reviewed the safety and blood levels of TR2. We’ll take blood and urine samples, to assess the safety and blood levels of TR2 and its breakdown products. We’ll also collect samples and measure the acidity of participants’ stomach juice, to test the effectiveness of TR2. \n\nParticipants will take up to about 11 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 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. We’ll recruit healthy participants by: advertising (newspaper and websites); by word of mouth; from volunteer databases; and via our websites.
REC name
London - Brent Research Ethics Committee
REC reference
14/LO/1595
Date of REC Opinion
9 Oct 2014
REC opinion
Favourable Opinion