Phase I Mass Balance Study
Research type
Research Study
Full title
A Phase I Mass Balance and Metabolism Study of 14C-Z-215 in Healthy Male Volunteers
IRAS ID
193871
Contact name
Jim Bush
Contact email
Sponsor organisation
Zeria Pharmaceutical Co. Ltd
Eudract number
2015-004001-16
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 11 days
Research summary
Z-215 is an investigational medicinal product intended to be used to treat heartburn by decreasing the acidity of the stomach.\nIn majority of cases heart burn associated with acid reflux (where acid produced in the stomach moves up into the oesophagus {foodpipe}) is a long term problem requiring prolonged treatment. Long term acid reflux can lead to changes in the stomach and oesophagus which in turn can result in malignancy and oesophageal constrictions. Z-215 is thought to have faster and prolonged action in reducing stomach acidity when compared to rabeprazole (a widely used drug to treat heartburn).\nZ-215 has been administered in healthy volunteers up to a dose of 540 mg as single dose and a maximum of 180 mg as multiple doses. No deaths or adverse events leading to discontinuation of the drug occurred during the study.\nSome of the side effects which were possibly or probably related to the test medication were nausea, vomiting, headache, dizziness, increased frequency of urination, ear infection and ear wax.\nOne of the intentions of this study is to find out what the body does to the drug and to characterise the amount of drug recovered after a single dose by mouth. The study will also look at the ways through which the drug is removed from the body by measuring the radioactivity associated with the breakdown products of the drug in blood , urine and faeces.\nSix subjects will be studied in a single group. Each subject will be administered a 20 mg single dose of 14C-Z-215 on Day 1. Subjects will reside at the unit at least until Day 7. On Day 7 if the they do not meet the discharge criteria, they may have to stay until Day 11 in the Clinical Research Unit. If the discharge criteria is not met on Day 11, subjects may be required to return to the CRU on an outpatient basis on Days 15, 19 and 23.\nThe effective radiation dose associated with this study is considered a minor risk for healthy subjects. The amount of radioactive material administered to the volunteers is typical for this type of clinical trial and is necessary to be able to determine the levels of metabolites (drug breakdown products) in urine and faeces in order to achieve the objectives of the study.\n
REC name
North East - York Research Ethics Committee
REC reference
15/NE/0376
Date of REC Opinion
4 Jan 2016
REC opinion
Further Information Favourable Opinion