Assess Bioavailability of AZD5718 in Fasted and Fed state in HV
Research type
Research Study
Full title
A randomised, single-dose, open-label, single-centre, crossover study to assess the relative bioavailability and safety of different formulations of AZD5718 in fasted and fed state in healthy volunteers.\n
IRAS ID
290492
Contact name
Pablo ForteSoto
Contact email
Sponsor organisation
AstraZeneca UK
Eudract number
2020-004963-15
Duration of Study in the UK
0 years, 1 months, 27 days
Research summary
This study is a randomised, open-label, crossover study in healthy male and female subjects that is performed at a single study centre. The female volunteers will be of non-childbearing potential. The main aim of the study is to evaluate the relative bioavailability of single doses of AZD5718 administered orally using 2 different tablet formulations under fasted conditions (for 10 hours before dosing until 4 hours afterwards). The bioavailability refers to the amount of ingested study drug that reaches the blood circulation and is available to the body. One of the formulations (reference) has already been used in a clinical trial, the other one (test) is meant to be used in a patient-trial in the future. This clinical study also intends to investigate how food intake may affect the blood concentrations of AZD5718 after administration of the test formulation. The study consists of 3 treatment periods to compare the blood concentrations of the 2 different formulations of AZD5718 after administration of single doses.\n\nThere will be a washout period of at least 7 days between the 3 treatments. The study also comprises a screening visit and a final follow-up visit 5 to 7 days after the last administration of study drug. Sixteen subjects will be included. The study duration per participant will be approximately 2 months.This is not a first-in-human study as the study drug has been given to humans before in 4 clinical studies. The study drug, AZD5718, is being developed by the sponsor to reduce mortality, morbidity and hospitalization associated with acute cardiovascular incidents and inflammation as well as to reduce albuminuria in the Chronic Kidney Disease population.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
20/SC/0385
Date of REC Opinion
30 Dec 2020
REC opinion
Further Information Favourable Opinion