Comparing 2 netazepide forms: blood levels and effect on stomach acid
Research type
Research Study
Full title
A double-blind, single-dose, negatively controlled, two-way crossover study of the pharmacokinetics and pharmacodynamics of two prototype formulations of netazepide, a gastrin/CCK2 receptor antagonist, in healthy subjects. HMR code (19-005)
IRAS ID
266724
Contact name
Malcolm Boyce
Contact email
Sponsor organisation
Hammersmith Medicines Research (HMR)
Eudract number
2019-001901-26
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Netazepide (the study medicine) is an experimental medicine that works by blocking gastrin – a hormone (chemical messenger) that causes the stomach to make acid, and promotes growth and repair of cells in the stomach lining. Too much gastrin can be harmful, because it causes the stomach to make too much acid, and can cause illnesses such as stomach ulcers and tumours. We’re developing netazepide to treat patients with stomach diseases caused by too much gastrin. We’ve developed 2 new forms, which we hope will be better absorbed and reduce stomach acidity more effectively than previous forms.
We’ll compare the 2 formulations in 12 healthy volunteers, aged 18–45, over 3 sessions. The first session will be used to measure stomach acid without any study medicine. In Sessions 2 and 3, volunteers will take a single dose of 50 mg netazepide by mouth. They’ll take a different form in each session.
Participants will take up to 4 weeks to finish the study; they’ll make 2 outpatient visits, and stay on the ward for 6 nights in total.
A pharmaceutical company (Trio Medicines Ltd) is funding the study.
The study will take place at 1 centre in London.
REC name
London - London Bridge Research Ethics Committee
REC reference
19/LO/1051
Date of REC Opinion
16 Jul 2019
REC opinion
Favourable Opinion