A Pharmacokinetic food effect study with AZD9977 in healthy males
Research type
Research Study
Full title
An Open-label, Randomized, Four-way Cross-over, Single Oral Dose Study Comparing the Pharmacokinetics of Four Different Formulations of AZD9977 (Part A) and Influence of Food (Part B) in Healthy Male Subjects
IRAS ID
240600
Contact name
Pablo ForteSoto
Contact email
Sponsor organisation
Astra Zeneca AB
Eudract number
2017-004620-30
Duration of Study in the UK
0 years, 2 months, 16 days
Research summary
This is an open-label, randomised, single-dose, cross-over study to be performed in healthy male volunteers at a single study centre. The study comprises two parts. In Part A, three different solid (capsule) formulations with different release rates will be compared to an oral suspension of the study drug, AZD9977, under fasted conditions. Based on the results in Part A, one of the capsule formulations will be selected for testing under fed conditions in Part B of the study. The study will include a screening visit, an in-house treatment period of 9 days/8 nights (Part A), an in-house treatment period of 3 days/2 nights (Part B) and final follow-up visit 5 to 7 days after the last administration of study drug. There will be a washout period of at least 2 days between the doses for a subject. The research subjects will participate in both Part A and Part B. Twelve subjects will be randomized to ensure at least 8 evaluable subjects at the end of the last treatment period in Part A and 6 evaluable subjects at the end of Part B.
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 studies previously performed, AZD9977 was well tolerated in all study subjects and no safety concerns have been identified. AZD9977 is being developed for the treatment of congestive heart failure (CHF), particularly in patients who still have relatively good heart pump function but suffer heart failure due to inflammation of the heart’s blood vessels. AZD9977 is thought to decrease scaring and inflammation in the heart and tissues surrounding the heart’s blood vessels, thereby having positive effects on both heart and blood vessel functions.The main purpose of the study is to evaluate the relative bioavailability of different capsule formulations of AZD9977 compared to an oral suspension. 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. In this study the formulations with different release profiles will be evaluated and one selected for further development. The food effect on the selected formulation will be evaluated. 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
London - London Bridge Research Ethics Committee
REC reference
18/LO/0055
Date of REC Opinion
5 Feb 2018
REC opinion
Favourable Opinion