To assess the relative bioavailability and safety of AZD5718
Research type
Research Study
Full title
A randomized, single-dose, open-label, single-center, crossover study to assess the relative bioavailability and safety of different formulations of AZD5718 in healthy volunteers.
IRAS ID
273176
Contact name
Pablo ForteSoto
Sponsor organisation
AstraZeneca AB
Eudract number
2019-003938-16
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 26 days
Research summary
This is a randomised, single-dose, open-label, crossover study to be performed in healthy male and female volunteers at a single clinical centre. The female volunteers must be of non-childbearing potential. Twelve volunteers will be enrolled. The study comprises a screening visit, 5 treatment periods and a follow-up visit within 5 to 7 days after the last administration of study drug. During the first 2 treatment periods, volunteers will receive single oral doses of 50 mg AZD5718 (low-dose treatment) and during the other 3 treatment periods, single oral doses of 200 mg AZD5718 (high-dose treatment). The study drug, AZD5718, is to be taken with water under fasted conditions. There will be washout periods of 3 to 6 days between dose administrations.
In this study, volunteers will remain in-house at the Clinical Unit for a period of at least 17 days and 16 nights from Treatment Period 1, Day -1 (check-in) to 72 hours after last dose of Treatment Period 5 (check-out) (exact number of days and nights depends on the number of washout days between dose administrations).
This is not a first-in-human study as the study drug has been given to humans before. AZD5718 is being developed by the sponsor, AstraZeneca AB, to reduce mortality, morbidity and hospitalisation associated with acute cardiovascular incidents. The drug is thought to weaken the production of potentially harmful substances (pro-inflammatory and vasoactive leukotrienes) in the heart’s blood circulation.
The main purpose of the study is to assess the blood levels of different AZD5718 formulations compared with the study drug formulation used in another ongoing research study (reference treatment), in healthy persons. The study will also assess how safe the study drug is and how well it is tolerated after single doses of AZD5718 have been taken. No genetic testing will be performed in this study.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
19/SC/0523
Date of REC Opinion
6 Jan 2020
REC opinion
Further Information Favourable Opinion