BA, PK & Food Effect of different formulations of AZD5718 in HV
Research type
Research Study
Full title
A Randomized, 6 period, 6 treatment, Single dose, Open label, Single center, Crossover Study to Assess the Relative Bioavailability of Different Formulations of AZD5718 and the Food Effect on the Selected Formulation of AZD5718 in Healthy Volunteers
IRAS ID
237566
Contact name
Pablo ForteSoto
Contact email
Sponsor organisation
Astra Zeneca AB
Eudract number
2017-004303-43
Duration of Study in the UK
0 years, 2 months, 19 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. The study design allows for a total of six treatment periods to assess the relative bioavailability of different formulations under fasted conditions (Part 1; 5 treatment periods), and the food effect on the selected formulation (Part 2; one treatment period) of study drug, AZD5718. In addition to the treatment periods, the study comprises a screening visit and a final follow-up visit 5 to 7 days after the last administration of study drug. Subjects in Part 1 will be randomised to 1 of 10 treatment sequences. Fourteen subjects will be included to ensure that at least 10 subjects are evaluable at the end of the study. Subjects in Part 2 will receive the selected formulation with food. Ten subjects will be included to ensure that at least 8 subjects are evaluable at the end of the study.
This is not a first-in-human study. This means the study drug studied in this research project has been given to humans before. In this study, the relative bioavailability of different formulations of AZD5718 will be investigated in comparison with the spray-dried formulation (SDF) of AZD5718 previously use in research studies, to confirm appropriate drug exposure. Potential food-effect of a selected formulation will be determined in order to provide appropriate dose and dosing instructions for further development of AZD5718. The study drug 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 study drug will be taken orally in the form of tablets or film-coated tablets to be taken with water.
The main purpose of the study is to evaluate the relative bioavailability of different formulations of AZD5718 and compare it with the SDF previously used. In addition, the food effect on the selected formulation will be evaluated. Bioavailability refers to the fraction of an administered dose of unchanged study drug that reaches the systemic blood circulation. The information is critical to calculate dosages for non-intravenous administration of the study drug being developed. The study will also see how safe the drug is after single doses of the different formulations were taken. During the study an optional blood sample will be collected for genetic research and possible retrospective analysis.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
17/SC/0592
Date of REC Opinion
12 Jan 2018
REC opinion
Further Information Favourable Opinion