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A study to examine how the body processes and removes DC-806 in healthy male volunteers

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study aims to investigate how the body processes and eliminates a new substance. The research focuses on a drug known as DC-806 and its labeled version, [14C] DC-806, which contains a traceable marker to help track its movement. This investigation involves healthy individuals to understand the pharmacokinetics, which is the study of how a substance moves through the body, and the metabolism, which is the process by which the body breaks down substances.

Participants will be given a single dose of the medication in the form of an oral film-coated tablet or a capsule. During the study, researchers will monitor the excretion, or the process of eliminating substances from the body, by collecting urine and feces. The study also tracks the presence of the substance in the blood and plasma, which is the liquid part of the blood, to determine how the drug is absorbed and distributed over time.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Administration of the test substance
You will take a single oral dose (taken by mouth) of 800 mg of dc-806. this dose contains a specific amount of [14c] dc-806, which is a labeled version of the substance used to track how it moves through the body.
The medication is provided in the form of film-coated tablets and capsules.
Step 2
Monitoring and collection
The study involves measuring how the substance is excreted (eliminated from the body). this requires the collection of urine and feces (bowel movements) to determine the balance of the substance leaving the body.
If any vomiting occurs, that material will also be collected for analysis.
Step 3
Medical assessments
Blood samples will be taken to assess pharmacokinetics, which refers to how the body absorbs, distributes, metabolizes, and eliminates the drug. these samples include whole blood and plasma (the liquid part of the blood).
Regular health checks will be performed, including monitoring vital signs (such as blood pressure and heart rate), conducting a 12-lead electrocardiogram (a test that records the electrical activity of the heart), and performing clinical laboratory tests.
Any adverse events (unwanted or side effects) will be recorded throughout the process.

Who can join the trial?

14 criteria

You must be a male.
You must be between 18 and 55 years old at the time of the initial screening.
You must be in good physical and mental health, which will be confirmed by your medical history, a physical exam, laboratory tests, an electrocardiogram (a test that records the electrical activity of your heart), and your vital signs (measurements such as blood pressure and heart rate).
You must have a body mass index (a measure of your body weight in relation to your height) between 18.0 and 30.0 kg/m2.
You must weigh at least 50 kg.
You must be a healthy individual.
You must be willing and able to sign the informed consent form, which is a document that explains all details of the study before you agree to participate.
You must agree to avoid foods and drinks containing methylxanthine (found in coffee, tea, cola, chocolate, and energy drinks) and grapefruit (including juice) starting 48 hours before arriving at the site and for the entire time you are staying there.
You must agree to avoid any strenuous physical exercise (very heavy or intense physical activity) starting 96 hours before arriving at the site and during your stay.
You must agree to avoid alcohol starting 48 hours before the screening and for the duration of your stay.
You must stop all prescribed medications at least 14 days before arriving at the site.
You must stop all over-the-counter medications (medicines you can buy without a doctor's note), vitamins, food supplements, or herbal medications at least 7 days before arriving at the site, though occasional use of acetaminophen/paracetamol (common pain relievers) is allowed.
You must agree to use adequate contraception (methods to prevent pregnancy) and not donate sperm from the time you arrive until 90 days after receiving the study drug. This includes using methods like a vasectomy (a permanent procedure for men to prevent pregnancy), tubal ligation (a permanent procedure for women), hormonal contraceptives (birth control pills or similar), or an intrauterine device (a device placed in the uterus) combined with a condom.
If your partner is not able to become pregnant or is male, you must use a condom from 48 hours before the study until at least 30 days after receiving the study drug.

Who cannot join the trial?

18 criteria

You are an employee of the company conducting the study or the company that made the drug.
You have taken part in another drug study (a medical test involving new medicines) within the last 30 days.
You have participated in 4 or more other drug studies in the last 12 months.
You have donated or lost more than 450 mL of blood (the fluid that carries oxygen in your body) in the last 60 days.
You have donated or lost more than 1.5 liters of blood in the last 10 months.
You have had a serious or sudden illness (a period of being unwell) within the last 5 days that might affect safety checks.
You have been exposed to a certain amount of radiation (energy that can travel through the air, often used in medical scans) in a previous study within the last 1 to 3 years, depending on the specific amount.
You have had exposure to radiation for medical testing (other than dental X-rays or simple chest X-rays), for your job, or in another study within the last year.
Your veins (the tubes that carry blood back to your heart) are not suitable for receiving medicine or having blood taken.
You have any other medical condition or have received any other therapy (medical treatment) that the doctor believes could interfere with the results or your safety.
You have a history of allergies (harmful reactions to certain substances) to food or medicine.
You have an irregular defecation pattern, which means you go to the bathroom to pass waste less than once every two days on average.
You smoke more than 5 cigarettes, 1 cigar, or 1 pipe every day.
You are unable or unwilling to stop using tobacco products (such as cigarettes) for 48 hours before the study starts and while staying at the clinic.
You have a history of alcohol abuse (drinking too much alcohol) or drug addiction (including cannabis) within the last year.
You test positive for drugs or alcohol (including substances like cocaine, cannabis, or certain medicines) during the initial medical screening.
You drink more than an average of 24 units of alcohol per week.
You test positive for Hepatitis B, HCV (Hepatitis C virus), or HIV (a virus that affects the immune system).

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Verified sites

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Verified
Pharmaceutical Research Associates Group B.V.
Groningen, The Netherlands

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Investigated drugs

DC-806
is an experimental medication being tested to see how the body absorbs, uses, and gets rid of it. In this study, it is taken by mouth to help researchers understand how it moves through the body and how it is broken down.
[14C]-DC-806
is a special version of the experimental drug that contains a tiny, safe amount of a radioactive marker. This marker acts like a tracer, allowing scientists to track exactly how the medication travels through the body and where it is eventually released, such as through urine or stool.

What is already known about the treatment

DC-806
This medication is taken by mouth in the form of a film-coated tablet and is currently being studied in clinical trials. It is being investigated as a treatment for skin and connective tissue diseases. At a molecular level, it works by targeting specific biological processes to manage these conditions, and it belongs to a class of drugs being developed for specialized therapeutic use.
[14C]-DC-806
This substance is administered orally through a capsule and is used in research settings to track how the body processes medication. It contains a radioactive marker that allows scientists to observe how the drug is absorbed, distributed, and eventually removed from the body. This specific version is classified as a radiolabeled tracer used to study the movement and metabolism of the main drug within the human system.

Investigated diseases

Since the provided source data specifies that the study is conducted on "Healthy" participants and does not list any specific medical conditions or diseases being studied, there are no diseases to describe.