A study to compare how different medicines (rosuvastatin, digoxin, metformin, and furosemide) are handled by the body of healthy people and people with liver cirrhosis
This study is investigating how the body processes different common medicines in both healthy individuals and those with liver cirrhosis (where the liver is scarred). The medicines being studied are Rosuvastatin (for cholesterol), Digoxin (for heart conditions), Metformin (for diabetes), and Furosemide (a water tablet). We want to understand if scarring of the liver affects how these medicines are handled by the body. This is important because it could help doctors prescribe the right doses for people with liver conditions. Participants will receive these medicines, and researchers will monitor how their bodies react.
At a glance
What is this study about?
This study is designed to understand how the body deals with certain common medicines when someone has liver cirrhosis, compared to someone with a healthy liver. Liver cirrhosis means your liver has significant scarring, which can stop it from working as well as it should. Your liver plays a really important role in breaking down medicines, so if it's not working properly, medicines might stay in your system longer or not work as effectively.
The specific medicines we're looking at are ros-oo-va-stat-in (often used for high cholesterol), di-jox-in (for some heart conditions), met-for-min (for diabetes), and fyoo-roh-seh-mide (a 'water tablet' often used for fluid build-up). By studying how these medicines are absorbed, used, and removed from the body in both healthy people and those with liver cirrhosis, we hope to gain important insights.
Ultimately, this research could help doctors make better decisions about how to prescribe these and similar medicines for people who have liver problems. This means potentially adjusting doses to make sure the medicines are safe and work as well as they should, leading to better care for patients.
Key takeaways
- The study compares how medicines are processed in healthy people vs. those with scarred livers.
- It aims to improve medicine dosing for people with liver conditions.
- Four common medicines are being investigated: Rosuvastatin, Digoxin, Metformin, and Furosemide.
- Participants can be healthy adults or adults with mild or more advanced liver scarring (cirrhosis).
- It is a 'Phase 1' study, meaning it's an early look at how the medicines work in the body.
- Your liver plays a vital role in how your body handles medicines.
Who may be eligible?
This study is looking for two main types of participants. Firstly, healthy adults who don't have liver problems. Secondly, adults who have liver scarring, also known as liver cirrhosis.
For those with liver cirrhosis, the study is interested in two groups: those whose liver disease is considered 'compensated' (meaning it's not causing major symptoms yet) and those whose liver disease is 'decompensated' (meaning it's causing more noticeable health issues). The study uses specific medical terms, Child-Pugh A and Child-Pugh B, to describe these stages of liver health. In simple terms, this means your liver has a certain level of damage or scarring.
All participants must be at least 18 years old. Both men and women are welcome to take part.
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 currently have liver cirrhosis (scarring of the liver)?
- If you have liver cirrhosis, has your doctor told you if it's 'compensated' or 'decompensated' (Child-Pugh A or B)?
- Are you generally healthy and do not have serious liver problems (if you are considering the healthy volunteer group)?
What does participation involve?
Details about participation, including visits or assessments, taking medicine, and how long the study will last, are not available in this summary. However, because this is a study that involves taking medicines and looking at how your body handles them, it's likely you would need to visit a clinic or hospital regularly. During these visits, blood samples would probably be taken to measure the medicine levels in your body. You would receive the medicines being studied: Rosuvastatin, Digoxin, Metformin, and Furosemide, as directed by the study team. You would be carefully monitored throughout the study period. The total duration of your involvement isn't specified, but phase 1 studies often involve several visits over a few weeks or months.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
What is liver cirrhosis?
Liver cirrhosis is when the liver becomes badly scarred, which can stop it from working properly. It can be caused by various liver diseases.
Why are you studying these specific medicines?
These medicines (Rosuvastatin, Digoxin, Metformin, Furosemide) are commonly used, and understanding how they work in people with liver problems can help doctors give the right doses.
Will taking part affect my current medicines?
This would need to be discussed with the study team. You should tell them about all medicines you are currently taking.
What does 'compensated' and 'decompensated' cirrhosis mean?
'Compensated' means your liver is scarred but still working reasonably well. 'Decompensated' means the damage is more severe, leading to more health problems.
Do I have to pay to join the study?
No, you do not have to pay to join a clinical trial. All study-related care and medicines would be provided.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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