At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 26 enrolled
Drug / intervention
900mg TETA 4HCl Once Daily Formulation +1 moredrug
Likely dose
900mg TETA 4HCl Once Daily Formulationfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating 900mg TETA 4HCl Once Daily Formulation and 900mg TETA 4HCl Cuprior® for Wilson's Disease. Completed, enrolled 26 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWilson's Disease
CountriesUnited Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
202420252026
First PostedNov 2023
Enrollment StartJan 2024
Primary CompletionFeb 2024
Study CompletionFeb 2024
TodayJul 2026
First PostedNov 13, 2023
Enrollment StartJan 16, 2024
Primary CompletionFeb 8, 2024
Study CompletionFeb 16, 2024
TodayJul 2, 2026
Enrollment to primary: 22 daysPosted 2.6 years ago
Interventions
900mg TETA 4HCl Once Daily Formulationdrug
3x300mg trientine base tablets as a single AM dose
900mg TETA 4HCl Cuprior®drug
6 x150mg trientine base tablets in two equally divided doses