Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase I, Open-Label Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics of a Single 3 mg Cytisinicline Dose

This is an early research study (Phase I) investigating a medicine called cytisinicline, which is being developed to help people stop smoking. The main goal is to understand how the body processes and gets rid of cytisinicline in individuals who have kidney problems or are on dialysis. Our bodies usually break down and remove medicines through our kidneys. If kidneys aren't working properly, a medicine might stay in the body longer, or in different amounts, than usual. By carefully measuring the amount of cytisinicline in blood, urine, and dialysate (the fluid used in dialysis), researchers can figure out how kidney health affects the medicine's behaviour. This information is crucial for determining the correct and safe dose of cytisinicline for people with kidney conditions in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Achieve Life Sciences Inc.

Enrolment target

Start

24 Oct 2022

Nicotine addiction

What is this study about?

This study is about a medicine called cytisinicline, which is being looked at as a way to help people stop smoking. When you take a medicine, your body absorbs it, uses it, and then gets rid of it. This process is called `pharmacokinetics`, and it's important to understand how it works for each medicine.

For most medicines, your kidneys play a big role in removing them from your body. If someone has kidney problems, their kidneys might not be able to get rid of medicines as easily. This means the medicine could stay in their body for longer or reach higher levels than expected, which could change how it works or cause side effects. This study specifically wants to see how cytisinicline behaves in people with different levels of kidney health, including those who are having dialysis treatment.

To do this, the researchers will give a single dose of cytisinicline and then carefully measure how much of the medicine is in the blood, urine, and in the fluid collected during dialysis (if applicable). By tracking these levels over time, they can learn how quickly the medicine is absorbed, how long it stays in the body, and how it's cleared out. This information is vital to make sure that if cytisinicline becomes available, doctors will know how to safely prescribe it to everyone, including those with kidney conditions.

Key takeaways

This study is examining an anti-smoking medicine called cytisinicline.
It focuses on how the medicine affects people with kidney problems or on dialysis.
Researchers will accurately measure the medicine's levels in blood, urine, and dialysis fluid.
The findings will help doctors safely prescribe cytisinicline for those with kidney conditions.
This is an early-stage study to understand how the body handles the medicine.

Who may be eligible?

To join this study, you need to be at least 18 years old. There's no upper age limit, meaning older adults are welcome to participate if they meet other criteria.

Both men and women are eligible to take part in this research.

The study is specifically looking for people with different levels of kidney health, including those who are on dialysis, to understand how their kidney function affects the medicine being studied. Other specific health conditions or medications might prevent you from joining, but these will be discussed by the study team.

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 at least 18 years old?
Are you able to attend several clinic visits for sample collection?
Do you have kidney problems, or are you currently on dialysis?
Are you willing to provide blood and urine samples?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive a single dose of the study medicine, cytisinicline. Your participation will involve several visits to the clinic where medical staff will take blood samples frequently over a set period. They will also collect urine samples. If you are on dialysis, additional samples of the dialysis fluid will be taken. Throughout the study, your health will be monitored closely. This includes checking your heart with an ECG, regularly measuring your blood pressure and other vital signs, and performing standard lab tests to look at your overall health. The total duration of your involvement will depend on how long it takes to collect all the necessary samples after you receive the medicine.

Potential risks and benefits

Potential benefits of taking part include contributing valuable scientific information that could help many people in the future who need to quit smoking and have kidney problems. You will also receive careful medical attention throughout the study. However, like all medicines, cytisinicline may have side effects, and some procedures like blood draws carry minor risks such as bruising. The full list of potential risks will be explained to you in detail before you decide to join. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and it won't affect your future medical care.

Locations (2)

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

—
Unverified
Portugal
—
Unverified
Spain

Common questions

What is cytisinicline?

Cytisinicline is a medicine being tested to help people stop smoking by reducing cravings and withdrawal symptoms.

What are 'kidney problems' in this study?

This study is looking at people whose kidneys don't work as well as they should, including those who need dialysis treatment.

Will I stop smoking in this study?

The main goal of this early study is to understand how the medicine behaves in the body, not to test if it helps people quit smoking.

How long will I need to be involved in the study?

You will receive a single dose of the medicine, and your involvement will last for the period needed to collect all the necessary blood, urine, and dialysis fluid samples, which will be explained in detail by the study team.

What is dialysis?

Dialysis is a medical treatment that helps filter waste and excess fluid from the blood when a person's kidneys can no longer do this properly on their own.