RecruitingRare disease

A study comparing different zinc doses for the treatment of Wilson disease in healthy participants.

Fast replyRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This study focuses on Wilson Disease, a rare condition where too much copper builds up in the body. The purpose of the study is to investigate how different doses of zinc affect the way the body absorbs copper through the intestines. Participants may receive Galzin, a medication used to manage copper levels, or a different dose known as ET-700. Some may also receive a placebo.

To understand how the medications work, a substance called copper (64cu) chloride is used during the study. This is followed by a PET/CT, which is a specialized type of imaging scan that uses a radioactive tracer to create detailed pictures of the body's internal organs. By using this scan, researchers can measure the amount of copper that reaches the liver to see how much absorption has changed due to the different treatments.

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
Initial assessment
An imaging scan is performed using 64Cu chloride, which is a radioactive tracer used to track how the body handles copper. this scan involves a PET/CT, a specialized type of medical imaging, to establish a baseline measurement of copper levels in the liver.
Step 2
Medication administration
One of three different treatments is administered to assess how it affects copper absorption in the intestines. the treatment assigned will be either galzin, et-700, or a placebo (a substance with no active medicine).
If galzin is assigned, 0.15 grams of the zinc capsules are taken three times daily.
If et-700 is assigned, 0.15 grams of the zinc capsules are taken twice daily.
If a placebo is assigned, no active medicine is taken.
Step 3
Follow-up assessment
After the treatment period, a second imaging scan using 64Cu chloride is performed to measure the amount of copper in the liver.
Various blood tests are conducted to measure levels of zinc, total copper, exchangeable copper, and ceruloplasmin (a protein that carries copper in the blood).
A test is performed on peripheral blood mononuclear cells to check for changes in metallothionein, which is a protein that helps manage the balance of metals like zinc and copper in the body.
urine samples are collected to measure the amount of zinc and copper being excreted.

Who can join the trial?

7 criteria

You must be older than 18 years of age.
Your BMI (Body Mass Index, which is a measure used to determine if a person has a healthy weight for their height) must be lower than 30.
Women who are able to become pregnant must agree to use reliable contraception (methods used to prevent pregnancy, such as an intrauterine device (IUD) or hormonal contraception like pills, implants, patches, or rings) from the start of the study until 14 days after the final scan, unless they choose to avoid sexual contact for religious or personal reasons.
On the day you receive the tracer (a small amount of a substance used for medical imaging), women who can become pregnant must have a negative urine pregnancy test.
You must provide signed informed consent (a written document showing you understand the study and agree to participate) before any study tests begin.
You must be able to read and understand Danish well enough to follow the study steps and understand the consent forms.
You must be a healthy volunteer, meaning you do not have any existing medical conditions being studied.

Who cannot join the trial?

6 criteria

You have had an X-ray examination (a type of medical imaging that uses radiation) within the last 12 months.
You have a known hypersensitivity (an allergic reaction) to copper, the tracer substance known as 64CuCl2, or any ingredients used to make the medications Galzin or ET-700.
A doctor decides you are not suitable because your blood tests (medical tests used to check your health by analyzing blood samples) show abnormal results.
You have any contraindications (specific medical reasons or conditions that make a particular treatment or medication unsafe for you) for taking Galzin.
You suffer from claustrophobia (an extreme fear of being in small or enclosed spaces).
You are pregnant, breastfeeding, or are planning to become pregnant before the study ends.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Region Midtjylland
Aarhus, Denmark

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Zinc
(administered as Galzin) is a mineral supplement used in this study to compare how well it helps manage copper levels in the body.
Zinc
(administered as ET-700) is a mineral supplement being tested to see how effectively it can be used to control copper absorption.
Copper
is a substance used in this study to help researchers track and measure how much copper is being absorbed through the intestines and moving into the liver using special imaging scans.

What is already known about the treatment

Galzin
This medication is taken orally in capsule form and is widely used in medicine as a mineral supplement. It is primarily used to treat or prevent zinc deficiency and to help manage copper levels in conditions like Wilson's disease. At a molecular level, it works by blocking the body's ability to absorb copper from the intestines into the bloodstream. It is classified as a nutritional mineral supplement.
ET-700
This substance is administered orally in the form of capsules and is currently being studied for its effectiveness in managing metal levels in the body. It is mainly intended to help reduce copper absorption in patients with Wilson's disease. The medication works at the molecular level by interfering with the processes that allow copper to enter the body through the digestive tract. It is classified as a mineral-based therapeutic agent.
Placebo
This is an inactive substance administered orally that contains no active medicinal ingredients. In clinical trials, it is used as a control to compare against the effects of the actual medications being tested. It has no specific therapeutic indication or molecular mechanism of action. It is classified as an inactive control substance.
Copper (64cu) chloride
This substance is taken orally and is used in medical imaging research rather than as a standard treatment. It is specifically used in this study to help visualize how copper moves through the body using advanced scanning technology. At a molecular level, it acts as a tracer that allows doctors to track copper absorption in the liver and intestines. It is classified as a radiopharmaceutical tracer.

Investigated diseases

Wilson's Disease - This is a rare genetic condition that prevents the body from properly breaking down and getting rid of copper. As a result, copper builds up in various organs, most notably in the liver and the brain. The condition progresses as the excess metal accumulates over time. This buildup can lead to damage in the liver and neurological issues. The rate of accumulation depends on the body's ability to process the mineral.