Wilson's DiseasePhase 1NCT06128954
Study Comparing Once Daily Dose of 900mg of TETA 4HCL Against Cuprior® (450mg Trientine Base, Twice Daily).
A Phase 1 study testing 900mg TETA 4HCl Once Daily Formulation and 900mg TETA 4HCl Cuprior® in people with Wilson's Disease, run by Orphalan at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Wilson's Disease
- What is being tested?
- 900mg TETA 4HCl Once Daily Formulation and 900mg TETA 4HCl Cuprior®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Jan 2024to 16 Feb 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18 to 40 years
- Body weight: ≥ 50 kg
- BMI: 18.0 to 25.0 kg/m2
- Health: Generally healthy, with no clinically significant illnesses or surgeries in the past 12 weeks
- Willingness to comply with trial procedures and restrictions
Who cannot join
- Significant current or recurrent disease
- Acute significant disease or illness within 7 days before the start of the trial
- Clinically significant deviations in blood tests
- An estimated glomerular filtration rate (eGFR) of less than 60 ml/min/1.73m2
- Positive test for alcohol, drugs of abuse, hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab)
- Pregnant or breastfeeding women
Show all 14Show fewer
- History or regular use of tobacco or other nicotine-containing products within 6 months before the start of the trial
- Treatment with an investigational drug within 90 days or 5 half-lives (whichever is longer) or exposure to more than 3 investigational drugs within 12 months of first study drug administration
- Use of prescription medication (excluding female hormonal contraception or hormone replacement therapy)within 30 days or 5 half
- lives (whichever is longer) prior to first study drug administration, or use of over-the-counter (OTC) medication (including multivitamin, herbal, or homeopathic preparations; Paracetamol use ≤2g per day is permitted) during the 14 days or 5 half-lives of the drug (whichever is longer) before first study drug administration
- History of sensitivity/allergy to the study medications or components thereof (mannitol, colloidal anhydrous silica, glycerol dibehenate or magnesium-stearate)
- Donation or loss of 450 mL or more of blood or plasma within 16 weeks prior to first trial medication administration or intention to donate blood in the 16 weeks after completing the trial
- An inability to follow a standardised diet and meal schedule or inability to fast, as required during the trial
- Participants deemed to have difficult veins for cannulation/blood draws
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- 900mg TETA 4HCl Once Daily Formulation, 900mg TETA 4HCl Cuprior®
- Medical subject headings
- Hepatolenticular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Once Daily Dose Formulation (Treatment A) | Experimental | 1 x 900mg TETA 4HCl, new once daily formulation (3x300mg trientine base tablets as a single AM dose) Receives: Drug: 900mg TETA 4HCl Once Daily Formulation |
| Cuprior® comparator (Treatment B) | Active comparator | 2 x 450mg TETA 4HCl, Marketed Cuprior® formulation (6 x150mg trientine base tablets in two equally divided doses (450mg doses 8 hours apart) Receives: Drug: 900mg TETA 4HCl Cuprior® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Concentrations (AUC) of TETA 4HCL Following Administration of Two TETA 4HCL Tablet Formulations.
PK parameters derived by non-compartmental methods including: AUC 24 and AUCinf. PK sampling was done pre-first dose and then post-first dose for Treatment A (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48. Post-first dose for Treatment B (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8 (before 2nd dose), 8.5, 9, 9.25, 9.5, 10, 11, 12, 13, 14, 16, 20, 24, 36, 48.
Measured: Up to 48 hours post first dose initiation.
Plasma Concentrations (AUC) of N1-acetyltriethylenetetramine (MAT) Following Administration of Two TETA 4HCL Tablet Formulations.
PK parameters derived by non-compartmental methods including: AUC 24 and AUCinf. PK sampling was done pre-first dose and then post-first dose for Treatment A (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48. Post-first dose for Treatment B (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8 (before 2nd dose), 8.5, 9, 9.25, 9.5, 10, 11, 12, 13, 14, 16, 20, 24, 36, 48.
Measured: Up to 48 hours post first dose initiation.
Plasma Concentrations (AUC) of N1, N10-diacetyltriethylenetetramine (DAT) Following Administration of Two TETA 4HCL Tablet Formulations.
PK parameters derived by non-compartmental methods including: AUC 24 and AUCinf. PK sampling was done pre-first dose and then post-first dose for Treatment A (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48. Post-first dose for Treatment B (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8 (before 2nd dose), 8.5, 9, 9.25, 9.5, 10, 11, 12, 13, 14, 16, 20, 24, 36, 48.
Measured: Up to 48 hours post first dose initiation.
Pharmacokinetic Parameters (AUC) of TETA in Plasma
PK parameters derived by non-compartmental methods including: AUCinf and AUC 24. PK sampling was done pre-first dose and then post-first dose for Treatment A (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48. Post-first dose for Treatment B (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8 (before 2nd dose), 8.5, 9, 9.25, 9.5, 10, 11, 12, 13, 14, 16, 20, 24, 36, 48.
Measured: Up to 48 hours post first dose initiation.
Plasma Concentrations (Cmax) of TETA 4HCL Following Administration of Two TETA 4HCL Tablet Formulations.
PK parameters derived by non-compartmental methods including: Cmax.
Measured: Up to 48 hours post first dose initiation.
Pharmacokinetic Parameters (Time) of TETA in Plasma
PK parameters derived by non-compartmental methods including: Thalf and Tmax.
Measured: Up to 48 hours post first dose initiation.
Pharmacokinetic Parameters (Concentration) of TETA in Plasma
PK parameters derived by non-compartmental methods including: Clast and Cmax.
Measured: Up to 48 hours post first dose initiation.
Pharmacokinetic Parameters (AUC) of MAT in Plasma
PK parameters derived by non-compartmental methods including: AUCinf and AUC 24. PK sampling was done pre-first dose and then post-first dose for Treatment A (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48. Post-first dose for Treatment B (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8 (before 2nd dose), 8.5, 9, 9.25, 9.5, 10, 11, 12, 13, 14, 16, 20, 24, 36, 48.
Measured: Up to 48 hours post first dose initiation
Plasma Concentrations (Cmax) of N1-acetyltriethylenetetramine (MAT) Following Administration of Two TETA 4HCL Tablet Formulations.
PK parameters derived by non-compartmental methods including: Cmax.
Measured: Up to 48 hours post first dose initiation.
Pharmacokinetic Parameters (Time) of MAT in Plasma
PK parameters derived by non-compartmental methods including: Thalf and Tmax..
Measured: Up to 48 hours post first dose initiation
Pharmacokinetic Parameters (Concentration) of MAT in Plasma
PK parameters derived by non-compartmental methods including: Clast and Cmax..
Measured: Up to 48 hours post first dose initiation
Pharmacokinetic Parameters (AUC) of DAT in Plasma
PK parameters derived by non-compartmental methods including: AUCinf and AUC 24. PK sampling was done pre-first dose and then post-first dose for Treatment A (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48. Post-first dose for Treatment B (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8 (before 2nd dose), 8.5, 9, 9.25, 9.5, 10, 11, 12, 13, 14, 16, 20, 24, 36, 48.
Measured: Up to 48 hours post first dose initiation.
Plasma Concentrations (Cmax) of N1, N10-diacetyltriethylenetetramine (DAT) Following Administration of Two TETA 4HCL Tablet Formulations.
PK parameters derived by non-compartmental methods including: Cmax.
Measured: Up to 48 hours post first dose initiation.
Pharmacokinetic Parameters (Time) of DAT in Plasma
PK parameters derived by non-compartmental methods including: Thalf and Tmax.
Measured: Up to 48 hours post first dose initiation.
Pharmacokinetic Parameters (Concentration) of DAT in Plasma
PK parameters derived by non-compartmental methods including: Clast and Cmax.
Measured: Up to 48 hours post first dose initiation.
Secondary outcomes (1)
To Compare the Safety and Tolerability of the Two TETA 4HCL Tablet Formulations.
The incidence, severity, and relationship of Treatment-Emergent Adverse Events (TEAEs).
Measured: Adverse events were collected from the patient signing the ICF until the end of study/follow-up (EOS/FU) visit. The Mean (Min, Max) number of days between signing ICF and the EOS/FU visit in the study was 20.2 (16, 25). All patients completed the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start16 Jan 2024
- Primary completion8 Feb 2024
- Study completion16 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Wilson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orphalan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Ashdown, MBBCh Ssc, Principal investigator, Richmond Pharmacology Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128954
- Sponsor's protocol ID
- ORPH-131-012
- Status last verified
- Aug 2026
- First submitted
- 2 Nov 2023
- Last updated
- 26 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06128954
- Acronym / sponsor ID
- ORPH-131-012
- Conditions
- Wilson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- OrphalanIndustry (pharma, biotech, devices)
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 16 Feb 2024 (actual)
- First posted
- 13 Nov 2023 (actual)
- Results
- Posted 15 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Once Daily Dose Formulation (Treatment A) | Experimental | Drug: 900mg TETA 4HCl Once Daily Formulation1 x 900mg TETA 4HCl, new once daily formulation (3x300mg trientine base tablets as a single AM dose) |
| Cuprior® comparator (Treatment B) | Active comparator | Drug: 900mg TETA 4HCl Cuprior®2 x 450mg TETA 4HCl, Marketed Cuprior® formulation (6 x150mg trientine base tablets in two equally divided doses (450mg doses 8 hours apart) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: 18 to 40 years
- Body weight: ≥ 50 kg
- BMI: 18.0 to 25.0 kg/m2
- Health: Generally healthy, with no clinically significant illnesses or surgeries in the past 12 weeks
- Willingness to comply with trial procedures and restrictions
Key exclusion criteria (14 listed)
- Significant current or recurrent disease
- Acute significant disease or illness within 7 days before the start of the trial
- Clinically significant deviations in blood tests
- An estimated glomerular filtration rate (eGFR) of less than 60 ml/min/1.73m2
- Positive test for alcohol, drugs of abuse, hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 900mg TETA 4HCl Once Daily Formulation3x300mg trientine base tablets as a single AM dose | Drug | Once Daily Dose Formulation (Treatment A) |
| 900mg TETA 4HCl Cuprior®6 x150mg trientine base tablets in two equally divided doses | Drug | Cuprior® comparator (Treatment B) |
Primary outcome
Plasma Concentrations (AUC) of TETA 4HCL Following Administration of Two TETA 4HCL Tablet Formulations.
Time frame: Up to 48 hours post first dose initiation.
PK parameters derived by non-compartmental methods including: AUC 24 and AUCinf. PK sampling was done pre-first dose and then post-first dose for Treatment A (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48. Post-first dose for Treatment B (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8 (before 2nd dose), 8.5, 9, 9.25, 9.5, 10, 11, 12, 13, 14, 16, 20, 24, 36, 48.
Plasma Concentrations (AUC) of N1-acetyltriethylenetetramine (MAT) Following Administration of Two TETA 4HCL Tablet Formulations.
Time frame: Up to 48 hours post first dose initiation.
PK parameters derived by non-compartmental methods including: AUC 24 and AUCinf. PK sampling was done pre-first dose and then post-first dose for Treatment A (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48. Post-first dose for Treatment B (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8 (before 2nd dose), 8.5, 9, 9.25, 9.5, 10, 11, 12, 13, 14, 16, 20, 24, 36, 48.
Plasma Concentrations (AUC) of N1, N10-diacetyltriethylenetetramine (DAT) Following Administration of Two TETA 4HCL Tablet Formulations.
Time frame: Up to 48 hours post first dose initiation.
PK parameters derived by non-compartmental methods including: AUC 24 and AUCinf. PK sampling was done pre-first dose and then post-first dose for Treatment A (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48. Post-first dose for Treatment B (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8 (before 2nd dose), 8.5, 9, 9.25, 9.5, 10, 11, 12, 13, 14, 16, 20, 24, 36, 48.
Pharmacokinetic Parameters (AUC) of TETA in Plasma
Time frame: Up to 48 hours post first dose initiation.
PK parameters derived by non-compartmental methods including: AUCinf and AUC 24. PK sampling was done pre-first dose and then post-first dose for Treatment A (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48. Post-first dose for Treatment B (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8 (before 2nd dose), 8.5, 9, 9.25, 9.5, 10, 11, 12, 13, 14, 16, 20, 24, 36, 48.
Plasma Concentrations (Cmax) of TETA 4HCL Following Administration of Two TETA 4HCL Tablet Formulations.
Time frame: Up to 48 hours post first dose initiation.
PK parameters derived by non-compartmental methods including: Cmax.
Pharmacokinetic Parameters (Time) of TETA in Plasma
Time frame: Up to 48 hours post first dose initiation.
PK parameters derived by non-compartmental methods including: Thalf and Tmax.
Pharmacokinetic Parameters (Concentration) of TETA in Plasma
Time frame: Up to 48 hours post first dose initiation.
PK parameters derived by non-compartmental methods including: Clast and Cmax.
Pharmacokinetic Parameters (AUC) of MAT in Plasma
Time frame: Up to 48 hours post first dose initiation
PK parameters derived by non-compartmental methods including: AUCinf and AUC 24. PK sampling was done pre-first dose and then post-first dose for Treatment A (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48. Post-first dose for Treatment B (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8 (before 2nd dose), 8.5, 9, 9.25, 9.5, 10, 11, 12, 13, 14, 16, 20, 24, 36, 48.
Plasma Concentrations (Cmax) of N1-acetyltriethylenetetramine (MAT) Following Administration of Two TETA 4HCL Tablet Formulations.
Time frame: Up to 48 hours post first dose initiation.
PK parameters derived by non-compartmental methods including: Cmax.
Pharmacokinetic Parameters (Time) of MAT in Plasma
Time frame: Up to 48 hours post first dose initiation
PK parameters derived by non-compartmental methods including: Thalf and Tmax..
Pharmacokinetic Parameters (Concentration) of MAT in Plasma
Time frame: Up to 48 hours post first dose initiation
PK parameters derived by non-compartmental methods including: Clast and Cmax..
Pharmacokinetic Parameters (AUC) of DAT in Plasma
Time frame: Up to 48 hours post first dose initiation.
PK parameters derived by non-compartmental methods including: AUCinf and AUC 24. PK sampling was done pre-first dose and then post-first dose for Treatment A (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48. Post-first dose for Treatment B (hours): 0.5, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8 (before 2nd dose), 8.5, 9, 9.25, 9.5, 10, 11, 12, 13, 14, 16, 20, 24, 36, 48.
Plasma Concentrations (Cmax) of N1, N10-diacetyltriethylenetetramine (DAT) Following Administration of Two TETA 4HCL Tablet Formulations.
Time frame: Up to 48 hours post first dose initiation.
PK parameters derived by non-compartmental methods including: Cmax.
Pharmacokinetic Parameters (Time) of DAT in Plasma
Time frame: Up to 48 hours post first dose initiation.
PK parameters derived by non-compartmental methods including: Thalf and Tmax.
Pharmacokinetic Parameters (Concentration) of DAT in Plasma
Time frame: Up to 48 hours post first dose initiation.
PK parameters derived by non-compartmental methods including: Clast and Cmax.
1 secondary outcome
To Compare the Safety and Tolerability of the Two TETA 4HCL Tablet Formulations.
Time frame: Adverse events were collected from the patient signing the ICF until the end of study/follow-up (EOS/FU) visit. The Mean (Min, Max) number of days between signing ICF and the EOS/FU visit in the study was 20.2 (16, 25). All patients completed the study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Ashdown, MBBCh Ssc principal investigator
Richmond Pharmacology Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 900mg TETA 4HCl Once Daily Formulation and 900mg TETA 4HCl Cuprior® in people with Wilson's Disease, run by Orphalan at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma Concentrations (AUC) of TETA 4HCL Following Administration of Two TETA 4HCL Tablet Formulations. (time frame: Up to 48 hours post first dose initiation.). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.