Evaluation of safety, side effects and how the inhaled drug CHF10073 is absorbed, modified and removed from the body when administered alone or in combination with itraconazole in male and female healthy adults
This important early-stage study is looking at a new inhaled medication, CHF10073, which could eventually help people with a lung condition called pulmonary fibrosis. For now, we're testing it in healthy adult volunteers to understand how it affects them. We want to find out if it's safe to use, what possible side effects it might have, and exactly how the body processes the medication – how it's absorbed, changed, and eventually leaves the body. We'll also be checking how taking CHF10073 alongside a common medicine called itraconazole might change these effects. This foundational research helps ensure that future studies can be conducted safely.
At a glance
What is this study about?
This study is a very early step in developing a new medicine, CHF10073, which is taken by inhaling it, similar to an asthma inhaler. The overall goal of this type of research is to find new ways to treat serious lung conditions like pulmonary fibrosis, where the lungs become scarred and damaged.
In this first stage, we're not yet testing the medicine in people with pulmonary fibrosis. Instead, we're inviting healthy adult volunteers to take part. The main aim is to understand the basics of this new medicine. We want to be sure it's safe for people to use and identify any common side effects. We'll also carefully track how the body handles CHF10073 – how much of it gets into the body from the lungs, how the body processes it, and how it's eventually removed.
A key part of this study also involves seeing what happens when CHF10073 is taken at the same time as another common medicine called itraconazole. This is important because patients might need to take other medications alongside CHF10073 in the future, and we need to know if they interact with each other. This kind of careful, early research in healthy people is essential to ensure new medicines can be developed safely and effectively for those who need them most.
Key takeaways
- This is a first-time-in-humans study for a new inhaled drug.
- It aims to check the new drug's safety and how the body handles it.
- Healthy adult volunteers (aged 18+) are needed, both men and women.
- Researchers will also study interactions with another common medication.
- Participation helps advance potential future treatments for lung conditions.
Who may be eligible?
This study is looking for healthy adult volunteers. To take part, you need to be at least 18 years old, and there is no upper age limit, as long as you are generally healthy.
Both men and women can participate in this study. The most important thing is that you are in good overall health, as confirmed by the study doctors after a check-up. This helps ensure that any effects observed are due to the study medicine and not other health conditions.
The research team will carry out several health checks to make sure joining the study is right for you. They will review your medical history and perform some tests to confirm you meet all the health requirements.
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 comfortable potentially taking two different medications?
- Are you able to attend all required clinic visits?
- Do you understand you might stay overnight for some visits?
What does participation involve?
If you decide to take part in this study, you would first have a screening visit where doctors check your health and make sure you're suitable. Once accepted, you would receive the study medication, CHF10073, which you take by inhaling it. In some parts of the study, you might also take itraconazole. You will have regular visits to the clinic, which could involve staying overnight, for doctors to monitor your health, check for side effects, and take blood or urine samples to see how your body is handling the medicine. These visits help us understand the drug's safety and how it works in the body. The total length of your participation, including all visits and follow-ups, would be explained in detail by the study team.
Potential risks and benefits
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Common questions
What is pulmonary fibrosis?
Pulmonary fibrosis is a lung disease where the lungs become scarred and stiff, making it difficult to breathe.
Why is this study being done in healthy people?
This is a very early study (Phase 1) to first check how safe the new inhaled medicine is and how the body handles it before it is tested in people with the actual condition.
What is an inhaled drug?
An inhaled drug is a medicine that you breathe in, usually through a special device, so it goes directly to your lungs.
What are 'side effects'?
Side effects are any unwanted or unexpected effects that a medicine might have on your body, beyond its main purpose.
Will I get paid for taking part?
Many early-stage clinical trials compensate volunteers for their time and expenses. The study team can provide full details on this.
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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