A study using the radiotracer vercirnon to examine its distribution in the body of healthy participants for research on Crohn’s disease

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What is this study about?

This study examines Crohn’s disease, which is a long-term condition that causes inflammation in the digestive system. The study uses a special radioactive tracer called [11C]AZ14132516, which is a carbon-11 labeled version of a substance known as vercirnon. This tracer is given as a solution for injection through intravenous infusion, which means it is delivered directly into a vein. The purpose of the study is to examine where this radioactive tracer goes in the body and how it attaches to a specific protein called CCR9 in the abdominal area.

The study involves healthy participants who will receive the radioactive tracer during the research. After the tracer is given, special imaging scans called positron emission tomography or PET scans will be performed to track where the tracer travels in the body and how it binds to the CCR9 protein in different areas, particularly in the abdomen. The maximum amount of the tracer that will be given is very small, measured in micrograms, and the treatment period can last up to 60 days.

During the study, participants will undergo PET examinations to measure how much of the tracer is present in different regions of interest in the body. The researchers will calculate values that show how much of the tracer has accumulated in these areas and compare measurements between different PET scans. The study will also monitor any safety concerns or unwanted effects that may occur during the research. This research helps scientists understand how the tracer behaves in the body, which may be useful for future medical applications related to Crohn’s disease.

1 Initial screening and preparation

Your medical history will be reviewed and a physical examination will be conducted to confirm that you are healthy and eligible for the study.

Laboratory tests will be performed to check your blood and other health parameters.

An electrocardiogram (a test that measures the electrical activity of your heart) will be performed.

If you are a female of childbearing potential, a pregnancy test will be conducted to ensure you are not pregnant.

Your body weight and body mass index (a measure of body fat based on height and weight) will be checked to confirm they are within the required range of 50.0 to 100.0 kilograms and 18.0 to 30.0 kilograms per square meter.

2 Radiotracer administration and imaging

You will receive an administration of [11C]AZ14132516, which is a radiotracer (a substance containing a small amount of radioactive material that allows doctors to see where it goes in your body).

The radiotracer will be given through an intravenous infusion (directly into a vein).

After receiving the radiotracer, you will undergo a positron emission tomography scan, also called a PET scan. This is an imaging test that creates pictures of your organs and tissues to show where the radiotracer has distributed in your body.

The PET scan will focus on your abdominal area to see how the radiotracer binds to specific receptors in that region.

If you are a female of childbearing potential, another pregnancy test will be performed before the PET examination.

3 Second imaging session

You will undergo a second PET examination following the same procedure as described in the previous step.

You will receive another administration of the radiotracer [11C]AZ14132516 through intravenous infusion.

A second PET scan will be performed to compare the results with the first examination.

4 Contraception requirements during the study

If you are a female of childbearing potential and sexually active with a male partner who has not been sterilized, you must use at least one highly effective method of birth control throughout the study and for 7 days after your last radiotracer administration.

If you are a male participant who has not been sterilized and you are sexually active with a female partner of childbearing potential, you must use a condom with spermicide throughout the study and for 7 days after your last radiotracer administration.

Female participants must not breastfeed, donate eggs, or retrieve eggs for personal use during the study and for 7 days after the last radiotracer administration.

Male participants must not father a child or donate sperm during the study and for 7 days after the last radiotracer administration.

5 Safety monitoring

Throughout the study, any adverse events (unwanted or harmful reactions) will be monitored and recorded.

Your safety will be assessed through regular evaluations during all scheduled visits.

Who Can Join the Study?

You must be able to give signed informed consent, which means you agree in writing to take part in the study after understanding all the details, requirements, and restrictions.
You must be able and willing to attend all scheduled visits, follow all study rules, and complete all required tests and procedures.
You must be between 20 and 65 years of age at the time you sign the consent form.
You must be healthy, which will be checked through your medical history, a physical examination, laboratory blood and urine tests, and an ECG (a test that records the electrical activity of your heart) before you receive any study medication.
Your body weight must be between 50.0 and 100.0 kilograms, and your body mass index (a measure that uses your height and weight to determine if you are in a healthy weight range) must be between 18.0 and 30.0.
If you are a woman who can become pregnant, you must have a negative pregnancy test at the screening visit and before the PET examination (a type of imaging scan). You must use at least one highly effective method of birth control during the study and for 7 days after the last dose of the study substance. Your male partner should also use a condom with spermicide (a substance that prevents pregnancy). You must not breastfeed, donate eggs, or retrieve eggs for your own use during the study and for 7 days after the last dose.
If you are a man who has not had a sterilization procedure and are sexually active with a woman who can become pregnant, you must use a condom with spermicide during the study and for 7 days after the last dose. Your female partner should also use at least one highly effective method of birth control. You must not father a child or donate sperm during the study and for 7 days after the last dose.

Who Cannot Join the Study?

The study does not list specific exclusion criteria, which means the research team will determine who cannot participate based on individual medical assessment and safety considerations.
You should discuss with the research team if you have any health conditions, meaning any diseases or medical problems you currently have or had in the past.
You should inform the research team about all medications, which are any drugs or treatments you are currently taking.
Women who are pregnant, meaning expecting a baby, or breastfeeding, meaning nursing a baby, may not be able to participate due to safety concerns related to radiation exposure.
You should tell the research team if you have had recent imaging studies, which are medical tests that take pictures inside your body, especially those involving radiation.
You may not be able to participate if you have had previous severe allergic reactions, which are bad responses your body has to certain substances.
You should inform the research team if you have any problems with your liver or kidneys, which are organs that help clean your blood and remove waste from your body.
You may not be eligible if you have participated in another research study recently, especially one involving radiation or experimental drugs.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Karolinska Institutet	Solna	Sweden

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Sweden	Not recruiting	01.06.2023

Trial locations

Investigated drugs:

VERCIRNON

[11C]AZ14132516 is a radioactive tracer used in special imaging scans called PET scans. This medication helps doctors see and measure a specific protein called CCR9 in different parts of the body, particularly in the abdominal area. The radioactive marker allows the scanning equipment to track where the medication goes in the body and how it attaches to the target protein.

Investigated diseases:

Crohn's disease

Crohn’s Disease – Crohn’s disease is a chronic inflammatory condition that affects the digestive tract. It can occur in any part of the gastrointestinal system from the mouth to the anus, but most commonly affects the end of the small intestine and the beginning of the colon. The inflammation caused by this disease extends deep into the layers of the bowel tissue. Symptoms typically include abdominal pain, severe diarrhea, fatigue, weight loss, and malnutrition. The disease progresses in a pattern of flare-ups, where symptoms worsen, followed by periods of remission when symptoms improve or disappear. Over time, the ongoing inflammation can lead to complications such as strictures, which are narrowed areas in the intestine, or fistulas, which are abnormal connections between different parts of the intestine or between the intestine and other organs.

Trial ID:

2022-502843-36-00

Protocol code:

D9690C00003

Trial Phase:

Human Pharmacology (Phase I) – First administration to humans

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A study using the radiotracer vercirnon to examine its distribution in the body of healthy participants for research on Crohn’s disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?