A Study to Assess the Relative Bioavailability of Different Subcutaneous Formulations ofAZD6234
This study is testing different versions of a new medicine called AZD6234. Researchers want to see how well each version gets into the bloodstream and if there are any side effects. Twenty-one healthy men and women, aged 18 to 55, will take part at a single location in Nottingham, UK. Each participant will receive four different versions of the medicine as an injection under the skin. The study will involve several clinic visits and overnight stays to collect blood and urine samples. This helps the researchers understand the best way to use AZD6234 in the future.
At a glance
What is this study about?
Imagine you have a new key, and you want to see if it works best with a silver coating, a gold coating, or maybe no coating at all. This study is a bit like that, but for a new medicine called AZD6234.
The main goal of this study is to compare how different versions of AZD6234 behave in the body. Researchers want to find out which version gets into the bloodstream most effectively and stably. They also want to carefully watch for any side effects people might experience with each version. This information is really important because it helps scientists choose the best way to give the medicine if it moves forward to treat specific conditions.
By testing these different versions in healthy volunteers, scientists can understand how the medicine works without the complexities of an illness. This early stage research is vital for developing new and better treatments in the future, ensuring they are as safe and effective as possible.
Key takeaways
- This study is testing different versions of a new medicine called AZD6234.
- It aims to find the best way the medicine gets into the body and to check for any side effects.
- 21 healthy men and women, aged 18-55, will take part in Nottingham, UK.
- Participants will receive the medicine as an injection under the skin, without food.
- It involves several clinic visits and overnight stays over about 19 weeks.
Who may be eligible?
To join this study, you need to be a healthy man or woman between 18 and 55 years old. If you're a woman, you must not be pregnant or breastfeeding. Your weight should be within a healthy range, generally not too underweight or significantly overweight.
You cannot take part if you have any serious health problems, either now or in the past. This includes issues with your heart, kidneys, liver, skin, lungs, brain, mental health, or stomach, as well as conditions like diabetes. You also can't have had any major illness, surgery, or injury in the four weeks before the study starts.
Certain blood test results or heart readings might mean you can't join. If you've recently taken a specific type of medicine (called an amylin analogue) or if you've ever taken AZD6234 before, you also won't be able to participate. Generally, being on any other prescribed or over-the-counter medication might exclude you.
- Are you a healthy man or woman between 18 and 55 years old?
- If you are a woman, are you definitely not pregnant or breastfeeding?
- Do you have a healthy body weight for your height?
- Have you had any serious medical conditions, surgeries, or injuries recently?
- Are you currently taking any regular medications, even over-the-counter ones?
- Have you ever taken AZD6234 or a similar medicine before?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you'll visit a clinic in Nottingham, UK. You'll go through 4 different treatment 'periods'. In each period, you'll receive one of the different versions of AZD6234 as a single injection under the skin (usually into your stomach area) when you haven't eaten.
For each of these 4 periods, you'll need to stay at the clinic for 6 nights. In total, you'll also have up to 10 extra appointments where you don't stay overnight. Throughout the entire study, which could last up to 19 weeks, doctors and nurses will take blood and urine samples. These samples will help them check how much of the medicine is in your body, how it's broken down, and ensure you're staying healthy.
Potential risks and benefits
Locations (1)
- Research SiteRuddington, United Kingdom· Recruiting
Common questions
What is AZD6234?
AZD6234 is a new medicine that is being investigated. This study is not for treating a specific illness, but to understand the medicine better.
Will I know which version of the medicine I'm getting?
No, each participant will receive all four versions of the medicine over a number of weeks, but the order might be different, and the researchers will compare them.
Do I get paid for taking part?
The information provided does not say if you will be paid. Typically, compensation for time and travel is offered for studies like this, and you should ask the research team about it.
What happens if I feel unwell during the study?
The medical team will be closely monitoring you, especially during your overnight stays. If you feel unwell, you should tell them immediately.
Why do I need to be 'healthy' to join?
By studying healthy people, researchers can see how the medicine works on its own, without any other health conditions making the results harder to understand.
How to find out more
AstraZeneca Clinical Study Information Center
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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