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COMPARISON OF ZINC ACETATE DOSE REGIMENS (GALZIN VS. ET-700) FOR THE TREATMENT OF WILSON DISEASE: A PHARMACODYNAMIC 64CUCL2 PET/CT STUDY IN HEALTHY PARTICIPANTS
EU CTIS ID: 2025-523372-24-00
What this study is testing
The aim of the study is to investigate the effect of Galzin 50 mg three times daily, ET-700 75 mg twice daily, and placebo on intestinal copper absorption in healthy volunteers. Using 64Cu PET/CT scans, we can assess intestinal copper absorption by measuring the amount of 64Cu in the liver.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age above 18 years.
- BMI below 30.
- Women of child-bearing potential (WOCBP) must agree to use reliable contraception from the inclusion; intrauterine device (IUD) or hormonal contraception (oral contraceptives, implant, transdermal patch, vaginal ring, or depot injection) until 14 days after the last scan unless they for religious or personal reasons are sexually abstinent.
- On the day of the tracer intake, fertile women must have a negative urine pregnancy test.
- Signed informed consent must be obtained before any trial-related examinations are performed.
- Ability to read and understand Danish sufficiently to comply with study procedures and provide informed consent.
You likely can't join if
- Exposure to X-ray examinations during the last 12 months.
- Known hypersensitivity to copper, 64CuCl2 (the tracer), or to any components of the Galzin® or ET-700 formulations.
- Deemed unsuitable by a physician based on abnormal inclusion blood tests.
- Known contraindications to Galzin treatment (please refer to the IMPD in Part I).
- Claustrophobia.
- Pregnancy, breastfeeding, or planning to become pregnant before the study is completed.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.