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

NCT06128954 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2026-08-26

Study results available
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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.

Conditions

  • Wilson's Disease

Interventions

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

Sponsors & Collaborators

  • Orphalan

    lead INDUSTRY

Principal Investigators

  • Thomas Ashdown, MBBCh Ssc · Richmond Pharmacology Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-16
Primary Completion
2024-02-08
Completion
2024-02-16

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06128954 on ClinicalTrials.gov