A Phase I, randomized, controlled, Latin-square, open-label study, to evaluate the effect of ADV7103 on gastric pH under fed and fasting conditions in adult healthy participants.
We are looking for healthy adults to take part in a study about a new medicine named ADV7103. The main goal is to understand how this medicine changes the level of acidity in your stomach. We will check this both when you've recently eaten and when you haven't. This type of study, called a Phase I study, is one of the first steps in testing a new medicine in people. It helps us learn how the medicine behaves in the body and if it's safe, before it's given to people who are unwell. This trial is important for developing potential new treatments for conditions such as distal renal tubular acidosis (dRTA), which affects how your kidneys deal with acid.
At a glance
What is this study about?
This study is testing a new medicine called ADV7103. This particular study is an early-stage trial, which means it's one of the first times this medicine is being given to people. The main purpose is to see how the medicine affects the acidity level in your stomach. Your stomach's acidity (which we call pH) changes naturally throughout the day, especially after you eat. We want to understand what the medicine does to this acidity, both when your stomach is empty and when it's digesting food.
Understanding how medicines affect stomach acidity is really important. It helps us learn if the medicine is absorbed properly into the body and how it might work or interact with food. This knowledge is crucial for developing medicines that work well and are safe for patients.
The information we gather from healthy volunteers in this study will help us understand more about ADV7103. Ultimately, this understanding could lead to new ways to help people with conditions like distal renal tubular acidosis (dRTA). This condition makes it hard for the kidneys to remove acid from the body, and medicines like ADV7103 might help manage it in the future.
Key takeaways
- This study tests a new medicine called ADV7103.
- It's an early-stage study in healthy adults.
- The main goal is to measure how the medicine affects stomach acidity.
- This helps understand how the medicine works and if it's safe.
- The findings could help people with kidney conditions like dRTA.
- You can withdraw from the study at any time.
Who may be eligible?
This study is looking for volunteers who are healthy adults. To take part, you need to be 18 years old or older – there isn't an upper age limit, so adults of any age above 18 can be considered. The study is open to both men and women.
Being 'healthy' means you generally don't have any major medical conditions that would affect how the medicine works or that would put your health at risk during the study. The study team will do a thorough health check to make sure it's safe for you to participate.
There will be other specific health requirements and checks to ensure the study is safe and the results are accurate. These will be fully explained by the study team before you decide 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 in good health?
- Are you willing to follow study instructions carefully?
- Are you able to attend regular study appointments?
What does participation involve?
If you decide to take part in this study, you will be given the study medicine, ADV7103. Because we want to compare how the medicine works with and without food, there will be times when you take the medicine after eating and times when you take it when you haven't eaten for a while. We will regularly check the acidity levels in your stomach. This will likely involve some small, temporary procedures to measure your stomach acid, which the study team will explain in detail. You will have regular appointments and medical checks to monitor your health and ensure the medicine is affecting you as expected. The total duration of your involvement in the study, including all visits and follow-up checks, will be fully explained to you before you agree to participate.
Potential risks and benefits
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Common questions
What does a 'Phase I' study mean?
Phase I is the first step where a new medicine is tested in people, usually healthy volunteers. It helps us understand how the medicine behaves in the body and if it's safe.
What is 'gastric pH'?
Gastric pH is a way of measuring how acidic or alkaline your stomach is. It changes throughout the day, especially when you eat.
Why is it important to test the medicine with and without food?
Food can affect how a medicine is absorbed and how it works. Testing both conditions helps us understand the best way for patients to take the medicine.
What is distal renal tubular acidosis (dRTA)?
dRTA is a kidney condition where the kidneys have trouble removing acid from the body. This study aims to help develop a potential new treatment for it.
Will I get paid for taking part?
Sometimes, studies offer a payment for your time and inconvenience. This will be discussed with you by the study team if it applies to this trial.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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