A study to test how BI 3031185 is tolerated by people with borderline personality disorder or attention-deficit/hyperactivity disorder.
This study is testing an investigational medicine called BI 3031185. It is designed for adults diagnosed with attention-deficit/hyperactivity disorder (ADHD) or borderline personality disorder (BPD). Because this is an early-stage (Phase 1) trial, the main goal is safety rather than proving whether the medicine works as a treatment. Doctors want to see how well people tolerate the drug, monitor any side effects, and track how the body absorbs and clears it. Volunteers will take the study medicine and visit a clinic regularly for health checks, including blood tests and heart tracings (ECGs). Taking part is entirely voluntary, and participants can leave the study at any point. By joining, volunteers help researchers understand whether this medicine is safe enough to be tested in larger clinical trials in the future.
A colpo d'occhio
Di cosa tratta questo studio?
Attention-deficit/hyperactivity disorder (ADHD) and borderline personality disorder (BPD) are common conditions that can significantly affect daily life, emotions, and concentration. While treatments currently exist, they do not work well for everyone, and some cause unwanted side effects. Researchers are continually exploring new options that might offer better, more tailored support in the future.
This clinical study focuses on a new investigational drug known as BI 3031185. It is a Phase 1 study, which means it is one of the earliest steps in testing a medicine in humans. Instead of checking if the drug cures or completely relieves symptoms, doctors want to learn how the human body handles it. They will closely measure how the drug is absorbed, how long it stays in the bloodstream, and whether it causes any uncomfortable or harmful reactions.
Finding out if a medicine is safe and well tolerated is an essential stage of scientific research. If the results are positive, researchers can design larger studies to see if BI 3031185 effectively manages ADHD or BPD symptoms. By taking part, participants provide vital information that could shape the next generation of mental health medications.
Punti chiave
- The trial tests an experimental medicine called BI 3031185 for safety and tolerability.
- It is open to adults aged 18 and older diagnosed with ADHD or BPD.
- This is an early-stage safety study, so personal health benefits cannot be guaranteed.
- Participants will have regular check-ups, including blood tests and heart monitoring.
- Taking part is completely voluntary, and you can stop at any time.
Chi può essere idoneo?
This study is open to men and women aged 18 and older who have been diagnosed with either attention-deficit/hyperactivity disorder (ADHD) or borderline personality disorder (BPD).
To keep volunteers safe, the study team will carry out health checks before anyone joins. People with certain serious physical health conditions, such as unstable heart or liver problems, may not be able to participate.
You may also be excluded if you are currently taking specific medications that could interact with the study drug, or if you are pregnant or breastfeeding. The study team will review your full medical history to decide if taking part is safe for you.
Questo studio potrebbe fare al caso tuo?
Rispondi a queste domande rapide per vedere se potresti essere idoneo. Questo è solo una guida — il team di ricerca prende la decisione finale.
- I am aged 18 or older.
- I have a formal diagnosis of ADHD or borderline personality disorder (BPD).
- I am generally in stable physical health.
- I am willing to attend clinic visits and undergo routine tests like blood samples.
- I am not pregnant, planning to become pregnant, or breastfeeding.
Cosa comporta la partecipazione?
Taking part involves several visits to a specialist study clinic. Before starting, you will attend a screening appointment where the team explains the study, answers your questions, and carries out basic health checks such as blood tests, urine tests, and heart tracings (ECGs). If you are eligible and agree to join, you will be given the study medicine, BI 3031185. During your visits, medical staff will closely monitor your wellbeing, track any side effects, and take regular blood samples to see how the medicine moves through your body. The team will give you a clear schedule showing the exact number of clinic visits, any required overnight stays, and final follow-up appointments to ensure you remain well after finishing the medicine.
Rischi e benefici potenziali
Luoghi (1)
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Domande comuni
What is a Phase 1 clinical trial?
A Phase 1 trial is an early stage of human testing. It focuses primarily on safety, finding out what side effects occur, and seeing how the body processes the new medicine.
Will this study cure my ADHD or BPD?
No, this trial is not designed to cure your condition. Its purpose is to test the safety and tolerability of the drug rather than to treat your symptoms long term.
Do I have to pay to take part?
No. Clinical trials in the UK do not charge you to take part. Study medications and tests are free, and trials often help cover travel expenses.
What happens if I change my mind?
You are free to leave the trial at any time. You do not need to give a reason, and your regular doctor and NHS care will not be affected in any way.
Can I keep taking my current medications?
It depends on the medication. Some medicines can interfere with the study drug. You must discuss all medications, supplements, and remedies you take with the study team.
Come saperne di più
Parla sempre con il tuo medico di base o specialista prima di decidere di partecipare a uno studio.
Interessato a partecipare?
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