PK trial to assess safety and tolerability of new TETA 4HCL formulation versus marketed Cuprior®
Research type
Research Study
Full 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.
IRAS ID
1009060
Contact name
Carla Bennett
Contact email
Sponsor organisation
Orphalan SA
Clinicaltrials.gov Identifier
Research summary
Wilson’s Disease (WD) is a life-threatening disease caused by a genetic mutation resulting in accumulation of copper. Excess copper is toxic and causes damage, leading to symptoms mostly related to liver and brain dysfunction. Fatal if untreated.
Treatment for WD is primarily with copper-binding medicine which forms a complex which can then be excreted, reducing copper levels. Traditionally, the first line medicine used is D-Penicillamine. Trientine is another copper-binding medicine, often used in patients intolerant to D-Penicillamine.
Orphalan has developed a medicine called trientine tetrahydrochloride (TETA 4HCL) which is a form of trientine. TETA 4HCL has been developed as a tablet containing 150 mg of trientine base. It has received widespread marketing authorisation.
TETA 4HCL treatment requires multiple doses per day. Some evidence literature supports once daily dosing, but there isn’t much data to support this. Orphalan has developed a new TETA 4HCL tablet containing 300mg trientine base, intended for once daily administration. Once daily administration would reduce the treatment burden on WD patients, increasing therapeutic compliance leading to better health outcomes.
This study assesses the metabolism, safety and tolerability of once daily 900mg dose of trientine base. Once daily formulation (3 x 300mg trientine base tablets) will be compared with current marketed formulation (3 x 150mg trientine base tablets twice a day) in healthy adult participants.
Prior to enrolment, participants will be assessed to ensure they are safe to dose. Those eligible will be randomly assigned to one day of treatment with once or twice daily TETA 4 HCL. Participants will then switch regimes. Participants will spend time as inpatients, where they will receive the medication and are monitored for side effects. After this, participants will return to the trials unit for an end-of-study outpatient appointment. From first dosing, the trial lasts a maximum of 21 days.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
23/SC/0415
Date of REC Opinion
15 Jan 2024
REC opinion
Further Information Favourable Opinion