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Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Evaluation of the effect of CHF6795 on the pharmacokinetics of midazolam, repaglinide and rosuvastatin in healthy subjects

This study is about understanding how a new medicine, called CHF6795, behaves when taken alongside other common medications. Specifically, it will look at how CHF6795 might change the way drugs used for anxiety (midazolam), diabetes (repaglinide), and high cholesterol (rosuvastatin) are processed by the body. This is a very early stage study, involving healthy adults, not people with illnesses. The main goal is to carefully check if CHF6795 affects the levels of these other drugs in the body, which is important for patient safety. While CHF6795 is eventually being developed for chronic cough, this particular study doesn't involve people with coughs. It's a key step in developing new medicines safely.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Chiesi Farmaceutici S.p.A., Chiesi Farmaceutici S.p.A.
Enrolment target
24
Start
22 Jan 2024

What is this study about?

This study, called a 'Phase I' human pharmacology study, is a very early step in developing a new medicine, CHF6795. Think of it like a meticulous test drive of a new car engine before it's put into a car and driven on the road. The main purpose here isn't to treat an illness, but to understand exactly how the potential new medicine, CHF6795, works in the body and how it might interact with other common medications people might take. The researchers want to see if CHF6795 changes how quickly or slowly other drugs like midazolam (sometimes used for sleep or anxiety), repaglinide (for diabetes), and rosuvastatin (for high cholesterol) are processed and used by your body. This information is crucial for ensuring that if CHF6795 is eventually approved, it can be prescribed safely alongside other necessary medicines.

Even though CHF6795 is being developed to potentially help people with chronic cough, this specific study does not involve anyone who actually has a cough. Instead, it carefully recruits healthy adult volunteers. This allows researchers to focus purely on how CHF6795 and the other drugs interact without other health conditions making the results harder to understand. By gathering this specific information early on, medical professionals can make sure that future studies involving patients are as safe and effective as possible.

This kind of detailed safety and interaction study is a standard and essential part of developing any new medicine. It helps scientists build a clear picture of how new drugs behave in the human body, providing important knowledge needed before any medicine can be made available to help people with health conditions.

Key takeaways

  • This is an early-stage study for a new medicine, CHF6795.
  • It helps understand how CHF6795 interacts with other common drugs.
  • The study involves healthy adults, not people with chronic cough.
  • Participation includes regular clinic visits and tests like blood draws.
  • Your involvement contributes to safer medicine development.
  • You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you need to be a healthy adult who is at least 18 years old. There is no upper age limit, meaning older adults can also take part as long as they meet all other health requirements.

Both men and women are welcome to participate. The study is particularly looking for healthy individuals because the goal is to understand how the new medicine and other drugs interact in a typical, healthy body, without other health problems affecting the results.

Specific details about your health, any medicines you currently take, and your lifestyle will be carefully checked by the study doctors to make sure it's safe for you to join. This helps protect your well-being and ensures the study results are clear.

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.

  1. Are you 18 years old or older?
  2. Are you generally in good health?
  3. Are you willing to visit the clinic multiple times?
  4. Are you comfortable with having regular blood and urine tests?
  5. Are you willing to follow specific instructions carefully?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll visit a study clinic multiple times. During these visits, you'll be given the study medicine (CHF6795) and the other common drugs being tested (midazolam, repaglinide, or rosuvastatin).

Doctors and nurses will regularly take blood and urine samples to check how the medicines are moving through your body. You might also have regular health checks like blood pressure, heart rate, and temperature measurements. The study will last for a set period, which will be explained in full detail, and will include follow-up appointments to ensure everything is well after taking the study medicines. The total duration of your involvement, including all visits and follow-ups, will be clearly outlined before you agree to participate.

Potential risks and benefits

Taking part in a study like this might not directly benefit your health immediately, as it's for research purposes. However, your involvement contributes significantly to medical science, helping to make new medications safer for everyone in the future. Potential risks might include discomfort or bruising from blood draws, or possible side effects from the study medicines and the drugs being tested, even though they are commonly used. All known potential risks and side effects will be fully explained to you before you agree to participate. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Belgium

Common questions

What is CHF6795 for?

CHF6795 is a new medicine being developed, eventually intended to help people with chronic cough, but this study isn't testing it for that condition.

Will this study cure my chronic cough?

No, this study is not designed to treat chronic cough. It's an early-stage study focusing on how medicines interact in healthy people.

Do I have to be sick to join?

No, quite the opposite! This particular study is looking for healthy adult volunteers to participate.

What kind of tests will I have?

You'll have regular blood and urine tests, along with routine health checks like blood pressure, to see how the medicines affect your body.

Can I stop participating if I want to?

Yes, you are free to stop participating in the study at any time, for any reason, and it won't affect your future 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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