Gastritis associated with H. pylori infection MedDRA version: 14.1 Level: LLT Classification code 10051790 Term: Helicobacter pylori gastritis System Organ Class: 100000004862
Conditions
Interventions
Product Name: Netazepide
Product Code: YF476
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: netazepide
CAS Number: 155488-25-8
Current Sponsor code: YF476
Concentration unit: mg milligram(s)
Sponsors
Hammersmith Medicines Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women aged 30-75 years 2. Positive H. pylori blood test and breath test 3. Otherwise good general health as judged by medical history, medical examination, vital signs, ECG and clinical laboratory tests 4. Body mass index 18-32 kg/m^2 5. Able to give fully-informed, written consent 6. Able to communicate with study personnel 7. Reliable, willing, and likely to comply with the protocol 8. Consent to our informing their GP of their participation in the study, and to our entering their details into the over-volunteering database (TOPS) 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 9 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3
Exclusion criteria
Exclusion criteria: We exclude the participants who meet the following criteria: * not in good general health (clinically significant abnormality in our screening tests, which include ECG, vital signs, physical examination, and laboratory safety tests of blood and urine); abuse of alcohol or drugs; drink, on average, more than 21 units of alcohol weekly (14 units for women); taken certain medicines or herbal remedies (ones that may affect the way the body handles or responds to the study medicine) up to 12 weeks before screening; have had a serious reaction to any medicine - particularly benzodiazepines; have had any condition or operation that might affect the way the body absorbs medicines; have had previous treatment for an H. pylori infection; objection by GP on medical grounds because they might increase the risk; or confound the assessment of netazepide; mental illness might compromise consent; * pregnant or breastfeeding; unwilling to comply with the contraception requirements of the protocol - because of the potential risk to the unborn or breastfed baby; * have donated blood, or taken part in another study, within the past 3 months; or don't agree not to donate blood, or take part in another study, during the 3 months after this study - because participants shouldn't expose themselves to unnecessary medicines more often than a few times a year, nor should they donate too much blood; or * smokers of more than 5 cigarettes a day - because participants must be able to comfortably abstain from smoking during the study Those criteria are designed to select healthy participants, who are robust enough to recover quickly from any adverse effects of netazepide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To find out if netazepide can heal inflammation of the stomach lining caused by H. pylori infection. ;Secondary Objective: To find out if netazepide: has any effect on 'biomarkers' - substances related to stomach health stomach health and function (gastrin, chromogranin A and pepsinogens I & II); can get rid of H. pylori infection; can get rid of symptoms of indigestion; and has any important side effects in people with H. pylori infection.;Primary end point(s): * Visual assessment of gastric mucosa at gastroscopy * Histology and real-time PCR of gastric biopsies for biomarkers (such as chromogranin A (CgA), histidine decarboxylase (HDC), matrix metalloproteinase-7 (MMP-7) and interferon gamma);Timepoint(s) of evaluation of this end point: Gastroscopy with biopsies: at baseline (Visit 3, before 1st dose) and after 12 weeks' treatment (Visit 7) with the study medicine | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. 13C urease breath test and Giemsa staining of gastric biopsies for the presence of H. pylori infection 2. Serum gastrin and pepsinogens I & II, and plasma CgA concentrations 3. Trough and peak pharmacokinetic (PK) parameters of netazepide 4. Symptoms of dyspepsia (indigestion) 5. Safety and tolerability of netazepide as judged by medical examination; ECG; vital signs; safety tests of blood and urine; and adverse events;Timepoint(s) of evaluation of this end point: 1. Breath test: at screening (Visit 2) and after 12 weeks' treatment (Visit 7) Biopsies: taken at gastroscopy before and after 12 weeks' treatment 2. Samples for gastrin, pepsinogens 1 and 2, and CgA, at baseline, after 3, 6, 9 and 12 weeks' treatment, and at follow-up. 3. Samples for PK of netazepide: predose and 1 hour post-dose (tmax) after the first dose, and after 6 and 12 weeks' treatment. 4. Dyspepsia questionnaire before and after 12 weeks' treatment. 5. Medical examination, ECG and vital signs: at baseline and after 3, 6, 9 and 12 weeks' treatment. Safety blood and urine tests: at baseline and after 3, 6, 9 and 12 weeks' treatment. Adverse events: monitored continually throughout the study. | — |
Countries
United Kingdom
Outcome results
None listed