Could a single daily pill simplify Wilson's disease treatment?

NCT ID NCT06128954

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This early-stage trial is testing whether a new once-daily version of the drug trientine (TETA 4HCl) works similarly to the current twice-daily formulation. The study involves healthy adult volunteers who will receive both versions in a crossover design to compare how the drug is absorbed and tolerated. The goal is to see if a simpler once-daily pill could be a viable option for managing Wilson's disease, a condition where the body retains too much copper.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Trientine (as TETA 4HCl), a copper-lowering drug, given as a new once-daily tablet formulation compared to the current twice-daily Cuprior® formulation.
What this could lead to
If successful, this could lead to a more convenient once-daily dosing option for people with Wilson's disease, potentially improving adherence and quality of life.
What could go wrong
This is an early Phase 1 study in healthy volunteers, not patients. It primarily measures drug levels and safety, not effectiveness. The new formulation may not match the current one in absorption or could have unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

26 people

The number who actually took part.

Started

Jan 2024

Finished

Feb 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Richmond Pharmacology Ltd

    London, SE1 1YR, United Kingdom

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