PK of AZD5718 in healthy vol, 3 period, 3 treatment single dose
Research type
Research Study
Full title
A Randomized, 3-period, 3-treatment, Single-dose, Open-label, Single-center, Crossover Study to Assess the Pharmacokinetics of 3 Doses of AZD5718
IRAS ID
269604
Contact name
Pablo ForteSoto
Contact email
Sponsor organisation
Astra Zeneca AB
Eudract number
2019-002796-33
Duration of Study in the UK
0 years, 1 months, 8 days
Research summary
This is a randomised, three-period, three-treatment, 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. The study design allows for assessment of how the study drug is absorbed (taken up into the body), metabolised (chemically broken down), distributed through the body, and excreted (removed from the body) (overall referred to as pharmacokinetics [PK]) when given at three different dose strengths under fasted conditions. There will be a washout period of at least 4 days between 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. Fourteen subjects will be included to ensure that at least 12 subjects are evaluable at the end of the study. The study drug will be taken orally in the form of immediate release tablets to be taken with water.
This is not a first-in-human study as the study drug has been given to humans before. The study drug, AZD5718, is being developed by the sponsor 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 this study is to evaluate the PK and exposure of three different dose strengths of AZD5718 to determine the appropriate drug exposure in the lower dose range (10 mg to 75 mg) and to compare with previous results. The study will also see how safe the drug is after single doses of the different dose strengths were taken. During each treatment period, blood and urine samples will be collected for assessment of drug metabolites (breakdown products) and biomarkers. No genetic research will be performed in this study.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
19/SC/0386
Date of REC Opinion
6 Sep 2019
REC opinion
Further Information Favourable Opinion