Study investigating how AZD4144 affects the pharmacokinetics of rosuvastatin in healthy participants
Research type
Research Study
Full title
An open-label, 2-period, 2-sequence cross-over study to assess the effect of AZD4144 on the pharmacokinetics of rosuvastatin in healthy participants
IRAS ID
1011351
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. But, people with cardiorenal diseases can have too much inflammation. The trial drug AZD4144 is designed to treat inflammation in people with cardiorenal diseases.
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 take rosuvastatin. Rosuvastatin is an approved medication that is used to treat high cholesterol and prevent heart problems. Because people who may take AZD4144 will often already be taking rosuvastatin, researchers want to learn how these medications will affect each other inside the body.
In this trial, researchers want to learn how AZD4144 affects how rosuvastatin moves throughout the body over time and how safe they are when taken together in healthy participants. Researchers do trials with healthy participants to learn how safe a drug is before doing trials in people with the condition they want to learn more about.
Trial Design: This is a Phase 1, randomized, open-label trial. Randomized means that a computer program will randomly assign the order each participant takes the treatments. Open-label means the participants, researchers, trial doctors, and other trial staff will know what each participant is taking. The participants will be in the trial up to 7 weeks.
Trial Population: This trial will include about 12 participants. To join this trial, people must be 18 to 50 years old and be healthy. In this trial, “healthy” means the participant does not have a cardiorenal disease or any other serious health issues.Summary of study results:
This is a summary of the main results from this trial overall. The individual results of each participant might be different and are not in this summary. A full list of the questions that researchers wanted to answer can be found on the websites listed at the end of this summary. When a full report of the trial results is available, it can also be found on these websites.
Researchers look at the results of many trials to decide which treatments work best and are safest. Other trials may provide new information or different results.
Always talk to a doctor before making any treatment changes.
Did taking AZD4144 alongside rosuvastatin increase the levels of rosuvastatin in the participants’ blood?
Yes. The researchers found that taking AZD4144 alongside rosuvastatin increased the levels of rosuvastatin in the participants’ blood compared to when they took rosuvastatin by itself.
To answer this question, the doctors took blood samples from the participants after they had taken:
X Rosuvastatin by itself (Treatment A)
X AZD4144 with rosuvastatin (Treatment B)
Using these blood samples, the researchers calculated:
X The average highest level of rosuvastatin in the participants’ blood, which is called the Cmax
X The average total level of rosuvastatin in the participants’ blood over time, which is called the AUCinf
X The average total level of rosuvastatin in the participants’ blood up until the last blood sample, which is called the AUClast
Using these measurements, the researchers compared the results after the participants had taken AZD4144 with rosuvastatin to the results after the participants had taken rosuvastatin by itself.
The researchers found that taking AZD4144 alongside rosuvastatin increased the levels of rosuvastatin in the participants’ blood compared to when they took rosuvastatin by itself.REC name
South Central - Berkshire Research Ethics Committee
REC reference
25/SC/0040
Date of REC Opinion
2 Apr 2025
REC opinion
Further Information Favourable Opinion