Randomized, open-label, multiple dose, two-period, two-treatment, cross-over pharmacodynamic study in healthy male and female participants under fasting conditions.
This research is an early step in developing a new medicine. We're looking for healthy adult volunteers, both men and women, of any age from 18 years upwards. The main goal is to understand how the medicine affects the body and how the body processes the medicine. Participants will take the medicine at different times, and we'll compare the results. This type of study, called a \"pharmacodynamic study,\" helps us learn important information about how the new medicine works before it's tested in people who are unwell. It's a small but vital part of bringing new treatments safely to those who might need them in the future. You'll be asked to fast before taking the medicine.
At a glance
What is this study about?
This study is an important first step in developing a new medication. It's designed to understand how a new medicine works inside the human body. We call this a 'pharmacodynamic' study. Think of it like taking a closer look at what the medicine actually does once it's in your system, rather than just how it moves around.
Because this is an early-stage study, we're inviting healthy volunteers to take part. This helps us to get a clear picture of the medicine's effects without other health conditions making the results harder to understand. Participants will be given the medicine more than once, and we'll compare how their bodies react each time. You'll also be asked not to eat for a certain period before taking the medicine, which is called 'fasting'. This helps us make sure the test results are consistent and accurate.
The information we gather from this study is really valuable. It helps researchers understand if the medicine has the desired effects and how strong those effects are. This knowledge is crucial for deciding if the medicine is promising enough to move on to later stages of testing with people who have the illness the medicine is designed to treat. Your participation helps pave the way for potential new treatments for many conditions.
Key takeaways
- This is an early study for a new medicine.
- It needs healthy adult volunteers, both men and women, aged 18 and over.
- The study looks at how the medicine works in the body and its effects.
- You will take the medicine more than once, with fasting required at times.
- Your participation helps develop potential new treatments for the future.
- You can stop participating at any time.
Who may be eligible?
This study is open to healthy adults, both men and women, who are 18 years old or older. There is no upper age limit, so adults of any age from 18 upwards can potentially join.
To be considered healthy, you would generally not have any long-term illnesses or be taking regular medication for a specific condition. The medical team will check your health carefully to make sure it's safe for you to take part.
Because it's an early study, we're not looking for people with a specific medical condition. Instead, we're focusing on how the medicine affects a healthy body. This helps us establish a baseline understanding of the medicine's behaviour.
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 and don't have any major medical conditions?
- Are you willing to fast (not eat) for certain periods?
- Are you available for multiple clinic visits?
- Are you comfortable with blood tests and medical check-ups?
What does participation involve?
If you decide to take part, you'll need to visit the study clinic several times. During these visits, you'll be given the study medicine, and your health will be monitored closely. This will involve things like blood tests, checking your heart rate and blood pressure, and answering questions about how you feel.
You'll receive the medicine on different occasions, and there will be specific times when you need to fast (not eat) before taking it. Between those times, there will be a ‘washout’ period where you won’t take the medicine, allowing it to leave your system before the next dose. The study involves different periods of treatment and assessments, but the exact number of visits and tests will be explained to you in detail by the study team. You'll also have follow-up checks after your last dose of the medicine.
Potential risks and benefits
Locations (1)
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Common questions
What does 'fasting condition' mean?
It means you'll be asked not to eat or drink anything (except water) for a certain number of hours before you take the medicine in the study.
What is a 'pharmacodynamic study'?
It's a type of study that looks at what a medicine does to your body and how your body reacts to it, checking for specific effects.
Will I get paid for taking part?
Often, early-stage studies like this offer payment for your time, travel, and inconvenience. The study team will be able to tell you more about this.
How long will I be involved in the study?
The study involves different periods of taking the medicine and follow-up. The exact duration will be explained by the study team, but it's typically over several weeks or months.
What is a 'Phase I' study?
Phase I is the very first stage of testing a new medicine in humans, usually in healthy volunteers, to check its safety and how it works in the body.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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