Study Comparing Once Daily Dose of 900mg of TETA 4HCL Against Cuprior® (450mg Trientine Base, Twice Daily).

Wilson's Disease Clinical Trial

Official title: A Phase I, Single Centre, Randomised, Interventional, Open-Label, Cross-Over Study to Evaluate the Pharmacokinetics (PK) and the Safety and Tolerability of a Total Daily Dose of 900mg of TETA 4HCL, Comparing a New Once Daily TETA 4HCL Formulation (300mg) (3x300mg Trientine Base Tablets, OD) With the Current Marketed Cuprior® Formulation (150mg) (3x150mg Trientine Base Tablets, BD) in Adult Healthy Male and Female Participants

Status Completed

Clinical Trial Summary

A randomised, open-label study evaluating the pharmacokinetics, safety, and tolerability of a new once daily dose of 900mg of TETA 4HCL by comparing it against the current marketed Cuprior® formulation (450mg trientine base, twice daily) in healthy male and female participants.

Clinical Trial Description

This is a single centre, phase I, randomized, controlled trial with a crossover design to evaluate the pharmacokinetics (PK), safety, and tolerability of a new once daily TETA 4HCL formulation (300mg) (3x300mg trientine base tablets, OD) compared to the current marketed Cuprior® formulation (150mg) (3x150mg trientine base tablets, BD) in adult healthy male and female participants.

Participants: 26 healthy participants will be enrolled to ensure 24 participants complete the study, with a balanced gender split.

Treatment: 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 (see study flow chart below).

To remain in line with current EU SmPC and US PIL, being:

• EU daily dose range of 450-975 mg of trientine base

• US daily dose range of 150-1500mg trientine base the following treatments will be administered according to the treatment allocation schedule below: A: 900mg TETA 4HCl once a day / new formulation = 3 tablets of 300mg trientine base as a single dose B: 900mg TETA 4HCl marketed Cuprior formulation = 6 tablets of 150mg trientine base in two equally divided doses

Patients will be randomised in a 1:1 ratio to either one of the following sequences:

Treatment Sequence Period 1 Period 2 Sequence 1 Treatment A Treatment B Sequence 2 Treatment B Treatment A

Assessments: Participants will be assessed for eligibility criteria and will be monitored closely throughout the study. Assessments will be performed during the study and at the end of the study follow-up visit.

Duration: The duration of the study will be up to approximately 7 weeks, from screening to follow-up:

• Screening will take place between days -28 and -2

• In-house period from D-1 to D3 with dosing on D1 of each treatment period

• Follow-up will take place on D7 of Treatment Period 2

At least 5 days and a maximum of 10 days between treatment period study drug administration

Objective: To evaluate the PK, safety, and tolerability of the new once daily TETA 4HCL formulation compared to the current marketed Cuprior® formulation. ;

Related Conditions & MeSH terms

• Wilson's Disease

• NCT number: NCT06128954
• Study type: Interventional
• Source: Orphalan
• Status: Completed
• Phase: Phase 1
• Start date: January 16, 2024
• Completion date: February 16, 2024