A Study to Investigate the Pharmacokinetics, Safety and Tolerability of AZD5462 in Participants with Renal Impairment
This study is investigating a new medicine called AZD5462. It's specifically for people who have kidney problems. The main goal is to understand how the body processes and uses this medicine (this is called pharmacokinetics). Researchers also want to check if the medicine is safe to use and what side effects it might cause. This is a very early-stage study, meaning it’s one of the first times this medicine is being tested in people. It will help doctors learn more about AZD5462 and decide if it could be a useful treatment in the future. The study is open to adults aged 18 and older, both men and women, who have issues with their kidneys.
At a glance
What is this study about?
This study is about a new medicine called AZD5462. When doctors are developing a new medicine, they need to make sure it's safe and that it works properly. This particular study is focusing on people who have kidney problems. Our kidneys play a very important role in our body by filtering waste and extra water from our blood. If the kidneys aren't working as well as they should, it can affect how the body handles medicines.
The main aim of this study is to see how the body deals with AZD5462 in people with kidney issues. This includes understanding how the body absorbs the medicine, how it spreads around, how it's changed by the body, and how it's eventually removed. This information helps doctors work out the right dose of a medicine and if it needs to be adjusted for people with kidney problems. They will also be carefully checking for any unwanted effects or health problems that might happen while taking the medicine.
This is an early-stage study, often called a 'Phase I' study. This means it's one of the first times the medicine is being given to people. The information gathered from this study is crucial for deciding if AZD5462 should be tested further in larger studies, and if it has the potential to become a new treatment option for certain conditions in the future. It’s an important step in the journey of developing new medicines.
Key takeaways
- Looks at a new medicine called AZD5462 for people with kidney issues.
- Aims to understand how the body uses the medicine and if it's safe.
- This is an early-stage study (Phase I).
- Open to adults aged 18 and over, both men and women.
- Participation involves taking the medicine and attending regular check-up appointments.
- You can always change your mind and leave the study at any time.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older. Both men and women are welcome to take part. The study is specifically looking for people who have problems with their kidneys, sometimes called 'impaired renal function'.
The research team will have a more detailed list of things they look for in a participant, and also things that would mean someone couldn't join. This is to make sure the study is safe for everyone involved and that they get accurate results. For example, there might be reasons why someone with other health conditions or who is taking certain medicines might not be able to participate.
It’s always best to talk to your doctor or the study team to find out if your specific health situation means you could be part of this research.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have a health condition that affects your kidneys?
- Are you willing to attend regular appointments for checks and tests?
- Are you able to take a new study medicine as instructed?
- Do you understand that this is an early-stage research study?
What does participation involve?
If you decide to take part in this study, you would be given the new medicine, AZD5462. You would need to attend several appointments at the study clinic. These visits are important for the research team to monitor your health closely and to assess how your body is reacting to the medicine.
During these visits, you might have various tests, such as blood tests, urine tests, and checks of your blood pressure and heart rate. These tests help the researchers understand how the medicine is working and if it's causing any side effects. The study team will explain exactly what kinds of tests you’ll have and how often.
The total length of time you would be involved in the study will be explained by the study team. This typically includes a period where you take the medicine, and then follow-up appointments after you stop taking it, to make sure you are well. You'll be given detailed instructions about your medication and what to do if you have any concerns.
Potential risks and benefits
Locations (1)
- —UnverifiedBulgaria
Common questions
What is 'Phase I' of a clinical study?
Phase I is the very first step where a new medicine is tested in people. It's usually a small study focused on safety and how the body handles the medicine.
What does 'impaired renal function' mean?
It means your kidneys aren't working as well as they should be. The study is for people who have some level of kidney problem.
Will I be given the actual medicine or a dummy pill?
In this type of study, you are usually given the actual new medicine, AZD5462, so researchers can see how it affects people.
How long will I be involved in the study?
The exact duration will be explained by the study team, but it includes taking the medicine and follow-up visits after stopping.
What if I feel unwell during the study?
You will have full support from the study team, and you should always tell them immediately if you feel unwell or have any concerns.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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