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

Condition studied

Wilson's Disease

Investigational medicinal product(s)

Eligibility

Primary endpoint

The primary endpoint is the change in mean hepatic 64Cu standard uptake value (SUV) from pre- to post-intervention between the three groups.

Endpoint detail

Change in plasma zinc, total copper, exchangeable copper, and ceruloplasmin levels from pre- to post-intervention between the groups., Change in metallothionein (a protein related to homeostasis of e.g. zinc and copper) induction in peripheral blood mononuclear cells from pre- to post-intervention between the groups., Change in urinary zinc and copper levels from pre- to post-intervention between the groups., Number of AEs in the three groups.