An Open-label, Randomized, Three-period, Crossover Study to compare the Pharmacokinetics of GB1211 upon dosing a capsule under fasting condition and a tablet under fasting and fed conditions in healthy volunteers.
This research is looking at a new medicine for serious conditions like non-small cell lung cancer, severe liver scarring (fibrosis), and cirrhosis. We need healthy volunteers to help us understand how this medicine works in the body. The study will test the medicine in two different forms – a capsule and a tablet – and see how it’s absorbed when you haven't eaten (fasting) compared to after a meal (fed). This helps us figure out the best way to give the medicine in the future. We'll be checking how much medicine is in your blood and urine over time to learn how your body processes it.
At a glance
What is this study about?
This study is a very early stage of research, often called a 'Phase I' trial. Its main goal isn't to treat illness yet, but to understand a new medicine called GB1211. We want to see how this medicine travels through the body, how quickly it gets absorbed, how high its levels get, and how long it stays in the system. This information is crucial because it helps researchers decide on the best way to give the medicine and what dose might be needed.
Imagine you take a pill – does it work better on an empty stomach or after food? Does a capsule work the same as a tablet? This study aims to answer these types of questions. By understanding how the body handles GB1211 under different conditions, scientists can make sure that when this medicine is eventually given to patients with conditions like lung cancer or liver disease, it has the best chance to be effective and safe.
The conditions mentioned, Non-small Cell Lung Cancer, Advanced Liver Fibrosis, and Cirrhosis, are serious illnesses. While this study isn't treating these conditions, the information gathered from healthy volunteers is a vital step in developing potential future treatments for patients. It’s like testing the engine of a new car before you put it on the road.
Key takeaways
- This study is for healthy adults aged 18 and over.
- It tests a new medicine (GB1211) for serious illnesses like lung cancer and liver disease.
- The main goal is to see how the body handles the medicine in different forms and with/without food.
- You will take the medicine and have blood and urine tests, plus general health checks.
- Your health and safety will be closely monitored throughout.
- Participation is voluntary, and you can leave at any time.
Who may be eligible?
To be part of this study, you need to be a healthy adult aged 18 years or older. There is no upper age limit, meaning older adults who are otherwise healthy can also participate.
Since this is an early-stage study focusing on how the medicine moves through the body, it's open to both men and women. The key requirement is that you are considered generally healthy and meet other specific health criteria that the study team will discuss with you.
Being 'healthy' for a clinical trial means you don't have any significant ongoing medical conditions that could affect how the medicine works or put you at undue risk. The study doctors will do thorough checks to make sure joining is safe for you.
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 healthy with no major ongoing medical conditions?
- Are you willing to take a new investigational medicine?
- Are you comfortable having regular blood and urine tests?
- Are you able to follow specific instructions about eating before taking medicine?
What does participation involve?
If you decide to take part, you will be in the study for a short period, likely involving a few visits to a clinic. You will receive the study medicine (GB1211) as either a capsule or a tablet. During the study, you'll be asked to take the medicine either when you haven't eaten for a while (fasting) or after a meal, depending on which part of the study you are in.
To understand how your body handles the medicine, the study team will take blood and urine samples at different times after you take the medicine. They will also keep a close eye on your health and safety. This involves regular checks like measuring your weight, blood pressure, pulse, and temperature, and taking an ECG (a simple heart tracing). You'll also have general health checks to make sure you're feeling well throughout the study. The total duration will involve a few periods of treatment and follow-up.
Potential risks and benefits
Locations (1)
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Common questions
What is GB1211 and why are you studying it?
GB1211 is a new medicine being developed for conditions like lung cancer and severe liver disease. We're studying it to understand how it works in the body and find the best way to give it in the future.
Will I get treated for cancer or liver disease?
No, this study is for healthy volunteers and is not a treatment for cancer or liver disease. It's an early step in developing the medicine for patients later on.
What does 'fasting' and 'fed conditions' mean?
Fasting means you haven't eaten for a certain amount of time before taking the medicine. Fed conditions mean you take the medicine after having a meal. We compare these to see how food affects the medicine's absorption.
What kind of tests will I have?
You'll have blood and urine tests, physical exams, checks of your heart (ECG), blood pressure, and weight to monitor how the medicine affects your body and to ensure your safety.
Can I leave the study if I change my mind?
Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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