Comparing Once Daily 900mg TETA 4HCL Vs Cuprior® in Healthy Participants

Completed Phase 1 NCT06128954

Study Description

This study compares the pharmacokinetics, safety, and tolerability of a new once daily dose of 900mg of TETA 4HCL to the current Cuprior® formulation in healthy male and female participants. The participants will be randomized to receive either the new or the current formulation of the drug, and then switch to the other formulation after a period of time. The assessment will take place during the study and at the end of the study follow-up visit. The duration of the study will be up to approximately 7 weeks. The objective of the study is to evaluate the PK, safety, and tolerability of the new once daily TETA 4HCL formulation compared to the current marketed Cuprior® formulation.

Study Details

Registry ID:
NCT06128954
Conditions:
Wilson's Disease
Phase:
Phase 1
Target Enrollment:
26 participants
Start Date:
Age Range:
18–40 years
Healthy Volunteers:
No

Study Locations (1 site)

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