Bioavailability, PK, DDI & Food Effect of AZD5718 in heathy subjects
Research type
Research Study
Full title
A Randomized, 5-Period, 5-Treatment, Single-Dose, Open-Label, Single-Center, Crossover Study to Estimate the Effect of AZD5718 on the Pharmacokinetics of Rosuvastatin, and to Assess the Relative Bioavailability of AZD5718 Oral Suspension vs AZD5718 IR Tablet Formulation and the Food Effect of AZD5718 in Healthy Volunteers
IRAS ID
216944
Contact name
Muna Albayaty
Contact email
Sponsor organisation
AstraZeneca
Eudract number
2016-003746-82
Duration of Study in the UK
0 years, 2 months, 6 days
Research summary
This is a randomised, five-period, five-treatment, open-label, single-centre, crossover clinical trial to evaluate the effect of a single dose of the sponsor’s study drug, AZD5718 on the pharmacokinetics of rosuvastatin. Pharmacokinetics refers to how the study medication is absorbed (taken up into the body), metabolised (chemically broken down), distributed through the body, and excreted (removed form the body). The clinical trial will also assess the relative bioavailability of AZD5718 immediate-release tablet formulation vs AZD5718 oral suspension, as well as the effect of food on AZD5718 absorption, in healthy male and female (non-childbearing potential) subjects. The study will comprise a screening visit, five different treatment periods and a follow-up visit a few days after the last dose of study medication was administered. Subjects will receive all five treatments.
This is not a first-time-in-human study. Single and repeated doses of AZD5718 have been administered to a total of 72 healthy subjects, with no possibly drug-related side effects of clinical significance. The study drug, AZD5718, is being developed by the sponsor for treatment of patients with high-risk coronary artery disease, which is associated with increased risk of heart attack and increased mortality, morbidity and hospitalisation. The study drug is thought to reduce the production of harmful inflammatory substances (inflammatory and vasoactive leukotrienes) in the heart’s blood circulation. In this clinical trial AZD5718 will be administered orally as an immediate-release tablet and a suspension. Rosuvastatin is an approved and commonly prescribed medication for the treatment of high cholesterol and is often prescribed to patients with coronary artery disease. In this clinical trial rosuvastatin tablets will be administered orally to evaluate the effect of AZD5718 on its pharmacokinetics, to make sure that these two drugs can be given to patients concomitantly. The study will also evaluate the relative bioavailability of the immediate-release tablet vs oral suspension formulation of AZD5718, examine the pharmacokinetic profiles of immediate-release AZD5718 when given under fed and fasted conditions, and assess the safety of single doses of AZD5718 in healthy subjects. As there may be a genetic association between the production of the inflammatory substances and an increased risk of heart attack, it is planned to collect and store blood samples for potential future exploratory genetic research aimed at finding genetic variations that may affect the actions of AZD5718. Participation in the genetic research part of the trial is voluntary.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
16/SC/0568
Date of REC Opinion
16 Nov 2016
REC opinion
Favourable Opinion