A phase 1, open-label, cross-over study in healthy volunteers to assess the pharmacokinetic profile of Prazosin and Cyproheptadine following single dose oral administration of KT110 tablet and following administration of Alpress and Periactine marketed tablets
This is an early-stage medical study, often called a Phase 1 trial. It's designed to understand how the body handles a new combination tablet, named KT110. This tablet contains two well-known medicines, Prazosin and Cyproheptadine, which are usually used separately. We want to see how these medicines behave when given together compared to when they are given as individual tablets (Alpress and Periactine). Healthy adult volunteers will take the medicine, and doctors will carefully measure how much of it gets into their blood and how long it stays there. The study aims to get a clear picture of how this new combination is processed by the body, which is important for future research into conditions like alcohol use disorder.
At a glance
What is this study about?
This study is a very early step in checking how a new combination of medicines works in the body. Imagine you're trying a new recipe – you first want to see how the ingredients mix and cook together before serving it to guests. Similarly, this study is looking at two existing medicines, Prazosin and Cyproheptadine, which are already approved and used individually for other conditions. The researchers have put these two medicines into one new tablet, called KT110.
The main goal is to understand how your body handles this new KT110 tablet. This includes things like: How quickly do the medicines get into your bloodstream? How much of them gets absorbed? And how long do they stay in your body before being cleared out? To figure this out, healthy adult volunteers will take the new KT110 tablet. They will also take the two medicines separately as the existing tablets (Alpress and Periactine) at different times, so researchers can compare the results directly.
This type of study is called a 'Phase 1' trial and is a crucial first step in developing new treatments. By understanding how the body processes these medicines when combined, researchers can then decide if it's safe and worthwhile to study KT110 further for specific health problems, such as alcohol use disorder. It's about gathering important information safely and carefully to pave the way for potential future treatments.
Key takeaways
- This is an early-stage study, helping scientists understand how a new combination medicine works.
- It involves healthy adult volunteers, not people with alcohol use disorder.
- The study compares a new combination tablet (KT110) with existing separate medicines.
- You'll have regular blood tests to check medicine levels in your body.
- The main goal is to gather safety and body-response information, not to treat illness.
- You can stop participating at any time.
Who may be eligible?
To join this study, you need to be a healthy adult who is at least 18 years old. There's no upper age limit, meaning older adults can also take part as long as they are healthy.
This study is open to both men and women. Being healthy is really important, as the study wants to understand how the new tablet works in a typical body without other illnesses affecting the results.
This means if you have any serious or ongoing health conditions, or if you're taking other regular medications, you might not be suitable for this particular study. The doctors will do health checks to make sure it's safe for you to participate.
- Are you 18 years old or older?
- Are you generally in good health?
- Are you comfortable having regular blood tests?
- Are you happy to commit to several study visits?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you'll be one of a group of healthy volunteers. You'll visit the study clinic several times. During these visits, you'll receive the study medication – sometimes the new KT110 tablet and other times the separate Prazosin (Alpress) and Cyproheptadine (Periactine) tablets. These will be given one at a time, with a break in between, so researchers can compare them effectively.
Throughout the study, doctors and nurses will regularly take blood samples to measure how much of the medicine is in your body over time. They will also check your general health, including things like your blood pressure, heart rate, and any side effects you might experience. You won't know if you're getting the new tablet or the existing ones when you take them. The total duration of your involvement in the study, including all visits and follow-ups, will be explained in detail by the study team, but it will involve several separate visits over a period.
Potential risks and benefits
Locations (1)
- —France
Common questions
What is a 'Phase 1' study?
It's a very early study in people, usually healthy volunteers, to check how a new medicine or combination is handled by the body and if it's safe enough to continue researching.
What are Prazosin and Cyproheptadine normally used for?
Prazosin is typically used for high blood pressure or sometimes for PTSD. Cyproheptadine is often used for allergies or to stimulate appetite.
Will I get better from alcohol use disorder by joining this trial?
No, this study isn't about treating alcohol use disorder. It's an early safety and body-response check for a new tablet; actual treatments would be looked at in later studies.
Will I get paid for taking part?
It's common for early-stage studies involving healthy volunteers to offer some payment for your time. The study team will provide details on this.
How long will I be involved in the study?
The study team will tell you the exact time commitment, including the number of visits and the total period of your participation.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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