TSPO Occupancy in the Human Lung
This research wants to understand how a drug called XBD173 works in healthy people's lungs. Specifically, we're interested in how it affects a protein called TSPO. We'll use special brain scans to see how much XBD173 is needed in the body to influence this protein. We'll also investigate if taking XBD173 with food changes how much of the drug gets into the body. This information will help scientists design future studies for conditions like Pulmonary Arterial Hypertension (PAH), where TSPO might play a role. The study is split into two parts: one to find the right amount of drug, and another to check how food affects it.
At a glance
What is this study about?
Imagine your lungs have a tiny protein called TSPO, and scientists think it might be important for understanding and treating lung conditions like Pulmonary Arterial Hypertension (PAH). Before they can test new treatments for these conditions, they need to know how certain drugs affect this protein in healthy people.
This study is designed to help us understand a drug called XBD173 and its interaction with TSPO. We want to find out how much XBD173 needs to be in your body to have an effect on TSPO in your lungs. We'll also check if eating food changes how your body takes in the drug. This information is really important because it helps scientists plan future research more effectively. It's like finding the right key to open a lock – we need to know the right amount of the drug to get the desired effect.
The study has two main parts. In the first part, we'll use special scanning equipment to see how XBD173 affects TSPO in your lungs at different drug doses. In the second part, we'll give you the drug with and without food to see if that makes a difference to how much drug your body absorbs. By taking part, you'll be helping scientists gain vital information that could lead to better treatments for lung conditions in the future.
Key takeaways
- This study is for healthy adults aged 25-75.
- It aims to understand how a drug, XBD173, affects a lung protein (TSPO).
- It will involve taking XBD173 by mouth, blood tests, and special scans.
- Researchers will check if food affects how your body absorbs the drug.
- The information gained could help develop future lung disease treatments.
- You can withdraw from the study at any time.
Who may be eligible?
To take part in this study, you need to be a healthy adult aged between 25 and 75. You must be able to understand the study and agree to participate by signing a consent form. For Part A of the study, you'll need to be comfortable lying still on your back for up to 90 minutes at a time for scans.
If you are a woman who could become pregnant, you can still participate if you use highly effective contraception throughout the study and for a period afterwards. This includes methods like implants, certain coils, or complete abstinence. We will also need a negative pregnancy test before you start. Men who are able to father children must also agree to use similar contraception. We want to make sure everyone is safe and aware of the study's requirements.
There are also some reasons why you might not be able to join. For example, if you are allergic to XBD173 or any of its ingredients, or if you have certain kidney problems. This study is for healthy volunteers, so anyone with significant existing medical conditions might not be eligible. We'll check all these details carefully to ensure your safety.
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 between 25 and 75 years old?
- Can you comfortably lie on your back for up to 1.5 hours?
- Are you able to speak and understand English fluently?
- If you are a woman who could become pregnant, are you willing to use an effective birth control method?
- If you are a man who could father children, are you willing to use an effective birth control method?
- Do you have any severe kidney problems or known allergies to XBD173?
What does participation involve?
If you join this study, it will involve several visits to the study centre, spread over a few weeks. You'll receive different doses of a drug called XBD173, which you'll take by mouth. Some visits will involve special scans (PET scans) where you'll lie comfortably to help us see how the drug affects your lungs. You'll also have blood samples taken at various times to measure the amount of the drug in your body.
In some visits, we'll ask you to come in without having eaten, and in others, you'll have a standard meal before taking the drug, so we can see how food affects it. You might also be given some doses to take at home. The exact number of visits and scans will depend on which part of the study you are in, but the team will explain everything fully. Each visit will involve careful monitoring and check-ups by the study team.
Potential risks and benefits
Locations (1)
- NIHR Imperial CRFVerified postcodeLondon, United Kingdom
Common questions
What is XBD173?
XBD173 is a drug being studied to understand how it affects a protein in the lungs called TSPO.
What is TSPO?
TSPO is a protein found in the body, including the lungs, that scientists believe might be involved in certain lung conditions.
Will I get paid to participate?
The study team will provide information on whether you will receive any payment or reimbursement for your time and travel.
What are PET scans?
PET scans are special imaging tests that help doctors see how organs and tissues are working, by using a small amount of a safe tracer.
Can I eat before my appointments?
For some visits, you'll need to come in on an empty stomach (fasted). The study team will give you clear instructions for each appointment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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