NCT06128954

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Orphalan · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Wilson's Disease

Interventions

Type	Name	Description
DRUG	900mg TETA 4HCl Once Daily Formulation	3x300mg trientine base tablets as a single AM dose
DRUG	900mg TETA 4HCl Cuprior®	6 x150mg trientine base tablets in two equally divided doses

Timeline

• Start date: 2024-01-16
• Primary completion: 2024-02-08
• Completion: 2024-02-16
• First posted: 2023-11-13
• Last updated: 2025-08-15
• Results posted: 2025-08-15

Locations

1 site across 1 country: United Kingdom