Open-label, non-randomised, single-dose, one sequence, two-period, cross-over study to investigate the effect of inhibition of P-glycoprotein and breast cancer resistance protein transporters by cyclosporine on the pharmacokinetics of CHF6001 in healthy volunteers.
This research is a small, early-stage study to understand how a new drug, CHF6001, travels through the body. We're specifically looking at whether another medicine, cyclosporine, affects how CHF6001 is handled by the body's systems. Cyclosporine can block tiny 'pumps' in your body that move drugs around. By understanding this, we can make sure CHF6001 is used safely and effectively, especially for conditions like Chronic Obstructive Pulmonary Disease (COPD), which causes ongoing breathing difficulties. This study involves healthy volunteers and helps us gather important information before the drug is tested in patients with COPD.
At a glance
What is this study about?
Imagine your body has tiny 'doormen' or 'pumps' that help move medicines in and out of your cells. This study is like watching to see how a new medicine, called CHF6001, gets around your body. We also want to find out what happens if we introduce another medicine, cyclosporine, which is known to block some of these doormen. This helps us understand if cyclosporine changes how CHF6001 works.
The main goal of this study is to gather information on how CHF6001 behaves in humans. This is a very early step in developing new medicines. Although the drug might eventually be used for conditions like Chronic Obstructive Pulmonary Disease (COPD) – a long-term lung disease that makes it hard to breathe – this particular study is done with healthy volunteers, not people with COPD.
By carefully studying how these drugs interact, doctors can make better decisions about how to prescribe and use CHF6001 in the future. This helps ensure that the medicine is safe and works as well as possible for people who need it.
Key takeaways
- This is an early study testing how a new drug, CHF6001, works in the body.
- It also checks if another medicine, cyclosporine, changes how CHF6001 behaves.
- The study involves healthy adult volunteers, not people with a specific illness.
- It aims to make future use of CHF6001 safer and more effective for breathing conditions.
- Participation involves giving blood samples and taking study medications.
Who may be eligible?
To take part in this study, you need to be a healthy adult aged 18 years or older. This means you should not have any serious medical conditions.
Both men and women are welcome to participate. The study is specifically looking for people who are generally well and not taking many other medications, as this helps researchers see clearly how CHF6001 and cyclosporine interact without other health issues complicating the results.
More detailed checks will be done by the study team to make sure it's safe for you 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?
- Are you generally healthy with no major medical conditions?
- Are you able to commit to several clinic visits?
- Are you willing to provide blood and urine samples?
What does participation involve?
If you decide to participate, you'll be asked to visit the study clinic several times. You'll receive a dose of CHF6001, and at another time, you'll receive both CHF6001 and cyclosporine. This will happen on different occasions with a break in between. During your visits, blood and urine samples will be taken regularly to measure how the drugs are moving through your body. You'll also have health checks, like blood pressure measurements.
The study involves two main periods where you'll receive the medications, separated by a washout period where you won't take study drugs. The total duration of your involvement, from your first screening visit to your final follow-up, will be explained in full by the study team.
Potential risks and benefits
Locations (1)
- —UnverifiedBulgaria
Common questions
What is COPD?
COPD stands for Chronic Obstructive Pulmonary Disease. It's a group of lung conditions that cause breathing difficulties, such as emphysema and chronic bronchitis.
Why is this study done on healthy volunteers?
Early studies like this are often done on healthy volunteers to understand how a new drug works in the body without other health problems affecting the results. This makes it safer and clearer to see the drug's basic effects.
What does 'pharmacokinetics' mean?
Pharmacokinetics is a scientific term that describes how your body handles a drug – how it absorbs, distributes, metabolises (breaks down), and removes it. In simple terms, it's about what your body does to the drug.
Will I get paid to participate?
Information about payment for your time and inconvenience will be provided by the study team if it is offered. This varies between studies.
Who is paying for this study?
This information is usually available in the detailed study documents. You should ask the study team for these details.
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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