Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1 Study to Investigate the Effect of Food on the Bioavailability of a Single Cytisinicline 3 mg Tablet and Evaluation of the Pharmacokinetics of Multiple 3 mg Doses (Three Times Daily) in Healthy Adult Smokers

This research is investigating a potential new medicine, Cytisinicline, aimed at helping people stop smoking. The study has two main goals: firstly, it wants to understand how food affects the body's absorption of a single 3mg tablet of Cytisinicline. Secondly, it will examine how the medicine behaves in the body when taken multiple times a day (three times daily). This is a very early-stage study, focusing purely on how the medicine works in the body, rather than whether it treats a specific illness. It involves healthy adult smokers and aims to gather important information before the medicine can be tested more widely.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Achieve Life Sciences Inc.

Enrolment target

Start

26 Jul 2023

No medical condition

What is this study about?

This study is about a medicine called Cytisinicline, which researchers hope could help people stop smoking. It’s an early-stage study, meaning it’s one of the first times this medicine is being given to people. The main purpose is to understand how the medicine behaves inside the body.

Think of it like this: when you take a medicine, your body has to absorb it, use it, and then get rid of it. This study specifically looks at things like how much of the medicine gets into your blood, how long it takes to get there, and how long it stays in your system. Researchers want to see if eating food at the same time as taking the medicine changes how your body handles it. They also want to see what happens when you take the medicine regularly, three times a day.

This kind of study, often called a Phase 1 study, is really important. It helps scientists learn vital information about a new medicine's safety and how it works in the body before it can move on to larger studies to see if it actually helps people with a specific condition. For this particular study, the participants are healthy adult smokers, as the medicine is intended to help with smoking cessation.

Key takeaways

This study is testing an early-stage medicine called Cytisinicline for smoking cessation.
It aims to understand how food affects the medicine and how it acts in the body over time.
Only healthy adult smokers are eligible to participate.
Participation involves taking the medicine and having blood tests and health checks.
The primary goal is to gather information on the medicine's safety and how it works in the body.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old. There's no upper age limit mentioned.

Critically, you must be a healthy adult who smokes cigarettes. This means you shouldn't have any major ongoing health problems or medical conditions. Doctors and nurses will check your general health carefully to make sure it's safe for you to take part.

Both men and women are welcome to participate in this research.

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?
Do you currently smoke cigarettes?
Are you generally healthy with no major medical conditions?
Are you willing to follow study instructions and attend appointments?
Are you able to agree to take part (give informed consent)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be given the medicine Cytisinicline. You would receive it once to see how food affects it, and then multiple times a day (three times daily) to understand how it acts in your body over time. During the study, healthcare staff will take blood samples to measure the amount of medicine in your system. They will also keep a close eye on your health by checking your heart (with an ECG), blood pressure, and other routine blood tests.

The visits will likely involve staying in a clinic for some periods, especially when the blood samples are taken. You might also have follow-up appointments after you've finished taking the medicine. The total length of your involvement in the study isn't specified but these early-stage studies often involve a few days or weeks of close monitoring.

Potential risks and benefits

Every clinical trial has potential risks, as new medicines can sometimes cause side effects. Possible risks in this study could include common side effects like headaches or feeling sick, or less common ones that the researchers will monitor closely. There might also be some discomfort from blood tests. However, the direct benefit to participants is usually not the primary goal in early-stage studies like this; the main benefit is contributing to medical knowledge that could help others in the future. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Portugal

Common questions

What is Cytisinicline?

Cytisinicline is a medicine that is being studied to see if it can help people stop smoking. This study is an early step in understanding how it works.

Why are they giving it to healthy smokers?

Because this medicine is meant to help with smoking, the study needs people who smoke. Starting with healthy individuals helps researchers understand the basic effects of the medicine before testing it in broader groups.

Will this study help me stop smoking?

While the medicine's eventual goal is to help people quit smoking, this specific study is focused on how your body handles the medicine, not whether it helps you stop smoking directly. It's too early to tell if it will help you personally.

What does 'Phase 1' mean?

Phase 1 means this is one of the very first studies of this medicine in humans. Its main goal is to check how safe it is and how it behaves in the body, rather than whether it treats a specific condition effectively.

What kind of tests will I have?

You'll have blood tests to measure the medicine in your body, and checks like an ECG (a heart check) and blood pressure measurements to make sure you're healthy.