An Open-label, Single-group, Three-period, Fixed-sequence, Phase I Study to Assess the Pharmacokinetics of AZD6793 Tablets When Administered Alone and in Combination with Itraconazole Capsules in Healthy Adult Female and Male Participants
This research study is about a new medicine called AZD6793 that could potentially help people with lung conditions like chronic obstructive pulmonary disease (COPD). The main goal is to understand how this new medicine behaves in the body. We are specifically looking at how much of the medicine gets into the blood and how quickly it leaves, both when taken alone and when taken at the same time as another common medicine, itraconazole. This is important because medicines can sometimes affect each other. This early-stage study helps scientists learn more about the medicine's safety and how it is processed, which is crucial before it can be given to a wider group of patients.
At a glance
What is this study about?
This study is focused on a new medicine called AZD6793. It's an early-stage study, which means we're still learning the basic information about it. The main thing we want to find out is how this medicine moves through your body. This includes how much of it gets absorbed into your bloodstream after you take it, and how long it stays in your system. This process is called pharmacokinetics, and it's a really important step in developing any new medicine.
We're also looking to see what happens when AZD6793 is taken at the same time as another common medicine called itraconazole. Sometimes, medicines can interact with each other in ways that change how they work. By understanding these interactions early on, researchers can figure out the safest and most effective ways for people to take AZD6793, either by itself or with other medicines they might already be taking.
This kind of research is vital for developing new, safer, and more effective treatments for conditions like Chronic Obstructive Pulmonary Disease (COPD). Even though this study doesn't involve people with COPD directly, the information learned here will help doctors and researchers understand how this potential new medicine might work for patients in the future.
Key takeaways
- This is an early-stage study of a new medicine for lung conditions.
- Researchers want to understand how the medicine works in the body.
- It tests the medicine alone and with another common medication (itraconazole).
- Healthy adult volunteers, aged 18 and over, are needed.
- Participation involves clinic visits and taking regular blood samples.
- The information helps develop safer and more effective future treatments.
Who may be eligible?
This study is looking for healthy adult volunteers. You must be at least 18 years old to take part. There is no upper age limit, as long as you are otherwise healthy.
Both men and women can join this study. Everyone who takes part needs to be in good general health. If you have any serious ongoing medical problems, you likely won't be able to participate.
The research team will carry out some health checks to make sure this study is safe and suitable for you. These checks ensure that the results we get are clear and that you are healthy enough to take the study medicines.
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?
- Are you generally in good health?
- Are you willing to visit the clinic regularly?
- Are you able to comfortably provide blood samples?
- Are you interested in helping medical research?
What does participation involve?
If you join this study, you'll be asked to take the new medicine, AZD6793, both by itself and together with itraconazole. Since it's a "fixed-sequence" study, you'll take them in a specific order designed by the researchers. You'll have several visits to the study clinic, including some stays overnight. During these visits, the research team will take blood samples regularly to measure how much of the medicine is in your body over time. They will also check your general health, including things like your blood pressure and heart rate. You’ll be closely monitored throughout the study period. The total time you'll be involved in the study, from your first visit to your last follow-up, will be explained by the study team.
Potential risks and benefits
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Common questions
What is COPD?
COPD stands for Chronic Obstructive Pulmonary Disease. It's a group of lung conditions that cause breathing difficulties.
What does 'pharmacokinetics' mean?
It's a fancy word for how a medicine moves through your body – how it's absorbed, distributed, processed, and eventually leaves your system.
Why is this study only for healthy adults?
Early-stage studies often use healthy volunteers to understand how a medicine works in a straightforward way, before testing it in people with the condition.
Will I get the actual new medicine if I join?
Yes, everyone in this study will receive the active medicine, AZD6793, either on its own or with itraconazole. There's no placebo.
What is itraconazole?
Itraconazole is a medicine commonly used to treat certain types of fungal infections. It's being used in this study to see if it affects how AZD6793 works.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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