A Randomized, Double-Blind (Sponsor-Unblinded), Placebo-Controlled, Single And Multiple Ascending Dose Study To Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Bioavailability and Food Effect (Open-Label) of Sage-319 in Healthy Adult Participants.
This research study is testing a new medication, called Sage-319, in healthy adult volunteers. The main goals are to find out if the medicine is safe and if people can tolerate it well. Researchers will also be looking at how the body absorbs, uses, and gets rid of the medicine (pharmacokinetics) and what effects it has on the body (pharmacodynamics). We'll also explore if eating food changes how the medicine works. This is an early phase study, meaning it's one of the first times this medicine is being given to people. The information gathered will help decide if Sage-319 might be a useful treatment for certain brain disorders in the future.
At a glance
What is this study about?
Imagine your brain uses tiny signals to communicate, a bit like a complex electrical network. Some brain conditions happen when these signals, especially one type called GABA, aren't working quite right, or when parts of the brain involved in movement and balance (the cerebellum) are also affected. This study is investigating a new medicine called Sage-319, which aims to help with these specific brain communication problems.
This early-stage study is a bit like a first test drive for Sage-319. It's happening in healthy adults to carefully check its safety before it's ever considered for people who are unwell. The main things researchers want to learn are if the medicine is safe to take, if it causes any side effects, and how it behaves once it’s inside the body – things like how much medicine gets into the bloodstream and how long it stays there. They also want to understand what effects the medicine has on the body.
Knowing how Sage-319 works in healthy people is a really important step. It helps scientists understand if it has the potential to help people with certain conditions in the future where brain signalling is out of balance. By taking part, healthy volunteers contribute vital information that could one day lead to new treatments for these challenging disorders.
Key takeaways
- New medicine Sage-319 being tested in healthy adults.
- Aims to check safety, how it's tolerated, and how the body uses it.
- Involves detailed medical checks and samples.
- Participants may receive active medicine or a placebo (dummy medicine).
- Results could help develop future treatments for brain signalling issues.
- Your participation is voluntary and you can leave at any time.
Who may be eligible?
This study is looking for healthy adults to take part. This means you should generally be in good health with no major ongoing medical problems that could affect how the study medicine works or how your body reacts to it.
Both men and women can join this study. You need to be at least 18 years old. There isn't an upper age limit mentioned, but typically, participants need to be fit enough to safely take part in all assessments.
Important note: Because this study is for healthy volunteers, if you have any known brain conditions or are currently taking medication for a serious illness, you would likely not be able to participate. The study aims to understand the new medicine in a straightforward way, without other health issues complicating the results.
- Are you 18 years old or older?
- Do you consider yourself generally healthy?
- Are you able to attend regular clinic appointments?
- Are you able to follow study instructions carefully?
- Are you comfortable with blood tests and medical examinations?
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 in this study, you'll be given the study medicine, Sage-319, or a 'dummy' medicine (a placebo). You won't know which one you're getting, nor will the study staff who are directly looking after you. This helps ensure fairness in the results. You will have several clinic visits where doctors and nurses will monitor your health, take blood and urine samples, and perform other tests to see how your body is reacting to the medicine. Some visits might involve staying overnight at the clinic. You'll also be asked to keep track of any changes you notice in your health.
For some parts of the study, you might be asked to take the medicine after eating, to see how food affects it. The total time you'd be involved in the study, including all visits and follow-ups, would be explained to you in detail before you agree to participate.
Potential risks and benefits
Locations (1)
- —Netherlands
Common questions
What is the main goal of this study?
The main goal is to check if a new medicine called Sage-319 is safe for healthy adults and how the body handles it.
Who can join this study?
This study is open to healthy adults, both men and women, aged 18 years and older.
What does 'placebo-controlled' mean?
It means some participants will get the actual medicine, and others will get a 'dummy' medicine that looks the same, but has no active ingredients. This helps compare the effects fairly.
Will I know if I'm getting the real medicine?
No, neither you nor the doctors treating you directly will know if you're receiving the active medicine or the placebo. This helps prevent bias in the results.
Why is it important to test on healthy people first?
Testing on healthy people helps researchers understand how the medicine works and if it's safe without other health conditions making it complicated. This is a crucial early step.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.