Blueclinical Investigacao E Desenvolvimento Em Saude Lda.
Verified
Porto, Portugal
Not recruiting
A study to evaluate how food affects the absorption of cytisinicline in healthy adult smokers
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What is this trial about?
A plain-language summary of the goals, design and what participants do
This study focuses on the drug cytisinicline. The purpose of the study is to determine how food affects the amount of the drug that enters the bloodstream and to observe how the body processes the medication over time when taken multiple times a day. This research is being conducted in healthy adult smokers.
Participants will be given film coated tablets containing 3 mg of cytisinicline. The study will examine how the drug behaves in the body after a single dose and after taking multiple doses three times daily. During the process, health indicators such as an electrocardiogram, which measures the electrical activity of the heart, as well as vital signs and clinical laboratory tests, will be monitored.
The research process
The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
9 criteria
- You must provide written informed consent, which means signing a document that says you understand the study and agree to participate before any tests begin.
- You must be willing to follow all the rules and steps required by the study.
- You must be a man or a woman who is 18 years of age or older at the time of signing the agreement.
- You must be a regular smoker of combustible cigarettes, meaning you smoke an average of at least 10 cigarettes per day.
- Your Body Mass Index (BMI), which is a measure of your weight in relation to your height, must be between 18.0 and 30.0.
- You must be in good health, as confirmed by your medical history, a physical exam, vital signs (such as blood pressure and heart rate), an ECG (a test that records the electrical activity of your heart), and laboratory tests.
- You must test negative for HIV (a virus that affects the immune system), Hepatitis B, and Hepatitis C (viruses that affect the liver).
- Women who cannot become pregnant, such as those who have had surgery to prevent pregnancy or are in post-menopausal state (the stage of life after periods have stopped), can participate.
- Women who are able to become pregnant must agree to use a reliable method of contraception (birth control) starting at least 4 weeks before entering the study and continuing until at least 4 weeks after the final dose of the study medication.
Who cannot join the trial?
20 criteria
- Having a known allergic reaction or hypersensitivity (an extreme immune system reaction) to the study drug or any of its excipients (inactive ingredients used to make the medicine).
- Consuming too much caffeine, which is defined as 800 mg or more per day.
- Having veins in either arm that are difficult to find, reach, or use for intravenous puncture (inserting a needle into a vein to deliver medicine).
- Having taken part in any other clinical trial (medical research study) within the last 2 months.
- Using any smoking cessation medications (medicines used to help stop smoking), such as patches, gum, electronic cigarettes, or specific drugs like bupropion or varenicline, in the last 8 weeks.
- Participating in more than two clinical trials in the last 12 months.
- Having donated blood, experienced significant blood loss (450 mL or more), or undergone plasmapheresis (a process that separates the liquid part of the blood from the cells) in the last 2 months.
- Being pregnant or lactating (breastfeeding).
- Using any medicinal products, including prescription drugs, non-prescription drugs, vitamins, or herbal supplements, in the last 2 weeks, unless a doctor decides it is safe.
- Having a known severe hypersensitivity reaction to any other medication.
- Using any smoking cessation aids after the initial screening process began.
- Testing positive for drugs of abuse or ethanol (alcohol).
- Having any medical condition related to the gastrointestinal (stomach and intestines), renal (kidneys), or hepatic (liver) systems, such as peptic ulcers, inflammatory bowel disease, or pancreatitis (inflammation of the pancreas), that could affect how the body processes the drug.
- Having had surgery on the stomach or intestines, such as a cholecystectomy (removal of the gallbladder) or gastrectomy (removal of part of the stomach).
- Having a stroke or an acute myocardial infarction (a heart attack) within the last 3 months.
- A history of hyperthyroidism (an overactive thyroid gland).
- A history of psychosis (a mental state where a person loses touch with reality).
- Having a renal creatinine clearance (a measure of how well the kidneys filter waste) that is below the normal range.
- Having ALT or AST levels (enzymes found in the liver) that are higher than the normal limit.
- Any other health condition that the doctor believes makes it unsafe or difficult to participate in the study.
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Investigated drugs
Cytisinicline is an experimental medication being tested to see how it is absorbed by the body and how it works when taken with food or on an empty stomach.
What is already known about the treatment
Cytisinicline - This medication is taken by mouth in the form of film-coated tablets. It is currently being studied in clinical trials to understand how the body processes it and how food might affect its absorption. This substance is primarily used to help people quit smoking by acting on the brain's receptors to reduce cravings and withdrawal symptoms. It belongs to a group of drugs known as nicotine receptor partial agonists, which work by mimicking nicotine just enough to satisfy the brain without the harmful effects of smoking.
Investigated diseases
No medical condition was specified in the provided source data.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-504260-42-00Protocol codeACH-CYT-11Estimated enrolment30 patientsSponsorAchieve Life Sciences Inc.
sourced from the EU Clinical Trials Register and site verification
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