Study to Assess the ADME of a Single Oral Dose of 14C labelled AZD1722
Research type
Research Study
Full title
A Phase I, Single centre, Open-label Study to Assess the Absorption, Distribution, Metabolism and Excretion (ADME) of a Single Oral Dose of 14C labelled AZD1722 in Healthy Male Volunteers.
IRAS ID
146472
Contact name
Arpeat Kaviya
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2013-004871-10
Research summary
AZD1722 is a new experimental drug that may be useful for the treatment of both heart and kidney failure and also in constipation related disorders. It works by blocking the NHE3 (sodium hydrogen exchanger) transporter in the bowel, which leads to reduced sodium and fluid absorption from the gut. This may be useful in helping to achieve a reduced salt uptake and in removing excess fluid from the body (which would be good in patients with kidney or heart failure) or treating the symptoms in patients with constipation-dominant irritable bowel syndrome (IBS-C).
In this study, the study drug, AZD1722, will be combined with radioactive carbon. The radioactive carbon bound with the drug will be traced and measurements made of the amount of drug in the blood, urine and faeces.
8 healthy male volunteers aged 50 or over will participate in this study as a single group. The study involves 3 visits over approximately 7 weeks. There will be 1 screening visit, 1 dosing visit consisting of a 9 day (approximately) stay followed by 1 follow up visit.
REC name
London - London Bridge Research Ethics Committee
REC reference
13/LO/1954
Date of REC Opinion
14 Mar 2014
REC opinion
Further Information Favourable Opinion