Study investigating different forms of AZD4144, BioA, FE and DDI of AZD4144 in healthy participants
Research type
Research Study
Full title
An open-label, randomised, 2-arm, 3-period, 6-treatment single dose, crossover study comparing the pharmacokinetics of 2 different formulations of AZD4144, and effect of food and omeprazole on the pharmacokinetics of AZD4144 in healthy participants
IRAS ID
1011352
Contact name
Kerstin Lösel
Contact email
Sponsor organisation
AstraZeneca AB
Research summary
Trial Background: Researchers are looking for a better way to treat inflammation related to cardiorenal diseases. Cardiorenal diseases are conditions that involve the heart and kidneys. Many people with cardiorenal diseases also have inflammation. Inflammation is a normal reaction of the immune system, which is the body's natural defense against viruses, bacteria, and anything the body does not recognize. However, people with cardiorenal disease can have too much inflammation. The trial drug AZD4144 is designed to treat inflammation in people with cardiorenal diseases.
In this trial, researchers want to learn how AZD4144 moves throughout the body over time in 3 different situations. These 3 situations match up with the 3 primary objectives in the table below.
Primary objective 1: The way a medication is taken can change the way it moves throughout the body. Researchers want to learn how AZD4144 moves throughout the body over time when it is taken by mouth as a tablet compared to when it is taken in liquid form as a drink.
Primary objective 2: The amount of food in the stomach when a medication is taken can change the way it moves throughout the body. Researchers want to know how AZD4144 moves throughout the body over time when it is taken on an empty stomach compared to when it is taken after a participant has eaten.
Primary objective 3: When people take 2 or more medications at the same time, one of the medications can change how the other medication moves throughout the body. Many people with cardiorenal diseases also take omeprazole. Omeprazole is used to reduce stomach acid and prevent ulcers. Because people who may take AZD4144 will often already be taking omeprazole, researchers want to learn how omeprazole affects the way AZD4144 moves throughout the body.
In this trial, researchers also want to learn how safe AZD4144 is in these different situations.
This trial will be done in healthy adults.REC name
London - West London & GTAC Research Ethics Committee
REC reference
25/LO/0095
Date of REC Opinion
3 Apr 2025
REC opinion
Further Information Favourable Opinion