A Four Way Crossover Thorough QT/QTc Study to Evaluate the Electrocardiographic Effects of Therapeutic and Supratherapeutic Doses of Cytisinicline in Healthy Smokers
This study is investigating a new medicine called cytisinicline, which is being developed to help people stop smoking. Researchers are looking closely at how this medicine might affect the electrical signals in a healthy person's heart, specifically focusing on a measurement called the 'QTc interval'. They want to see if different doses of cytisinicline change this heart measurement and by how much. The study also uses a well-known heart medicine, Avelox, as a comparison, as we already know how that affects the heart. By doing these careful checks, the scientists aim to ensure that cytisinicline is safe for your heart before it can be widely used to treat nicotine addiction.
At a glance
What is this study about?
This study is a special kind of clinical trial, often called a Phase I study. Its main goal is to understand how a new medicine, called cytisinicline, affects the electrical activity of your heart. Cytisinicline is being looked at as a possible treatment to help people stop smoking, also known as nicotine addiction.
Imagine your heart has a built-in electrical system that makes it beat. Doctors can measure this electrical activity using an electrocardiogram (ECG), which gives them a tracing. One key measurement on this tracing is called the 'QTc interval.' A QTc interval that is too long can sometimes be a sign of a problem, so medicines are carefully checked to see if they affect it.
In this study, researchers will give healthy smokers different doses of cytisinicline – a normal dose and a slightly higher dose – to see how it changes their QTc. They will also give a placebo (a dummy pill with no medicine) and another known medicine called Avelox, which is used as a comparison because its effects on the heart are well understood. By doing these comparisons, the scientists can figure out precisely how cytisinicline influences the heart's electrical rhythm, ensuring it's as safe as possible for future use.
Key takeaways
- This study evaluates a potential new stop-smoking medicine called cytisinicline.
- It focuses on how the medicine affects the heart's electrical activity (QTc interval).
- Healthy smokers aged 18 and over can take part.
- Participants will receive the new medicine, a placebo, and a known heart medicine.
- Regular heart checks (ECGs) and blood tests will be conducted.
- The aim is to ensure the new medicine is safe for the heart.
Who may be eligible?
This study is looking for volunteers who are healthy and smoke. You need to be at least 18 years old to take part, and there's no upper age limit. Both men and women are welcome to participate.
The main idea is to study how the new medicine affects a healthy heart, so generally, you shouldn't have any serious ongoing health problems. The study focuses on smokers because the medicine is being developed to help with nicotine addiction.
Exact details about other health conditions or medicines you might be taking would be discussed with the study team. They will carry out several checks to make sure this study is safe and right for you.
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 currently a smoker?
- Are you generally healthy, without major medical conditions?
- Are you able to attend several clinic visits for tests?
What does participation involve?
If you decide to take part, you'll visit the study clinic several times. You'll switch between receiving cytisinicline (the new medicine), a placebo (a dummy pill), and Avelox (another medicine used for comparison). This is called a 'crossover' study, and it means you'll experience each treatment at different times.
During your visits, you'll have regular ECGs (heart tracings) to measure your heart's electrical activity. Blood samples will also be taken to check how much of the medicine is in your body. Your heart rate and other vital signs will be monitored closely. The exact duration of your involvement will be clearly explained by the study team, including how many visits you'll need to make and how long each visit might last.
Potential risks and benefits
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Common questions
What is an ECG and why will I have one?
An ECG (electrocardiogram) is a simple, painless test that records the electrical activity of your heart. You'll have one to check how the study medicine affects your heart's rhythm.
Why are they studying this medicine in smokers?
This new medicine, cytisinicline, is being developed to help people stop smoking (nicotine addiction), so the study needs to test it in people who smoke.
What is a 'placebo'?
A placebo is a dummy pill that looks like the active medicine but contains no active ingredients. It's used to compare the effects of the active medicine more accurately.
Will I know which medicine I'm getting?
In a 'crossover' study like this, you will receive different treatments at different times, but during each period, you might not know if you're getting the active medicine or the placebo. This helps prevent bias.
Will I be paid to take part?
Information about reimbursement for your time or travel expenses will be provided by the study team. It's usually common for studies to cover these costs.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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