We are looking for up to 10 men and women with Wilson Disease aged 18 years or older to test a potential (i.e. investigational) medicine for treating Wilson Disease. You will be paid for your time and commitment if you participate in this clinical trial.
Clinical trial summary
- The investigational medicine works by binding to and removing excess copper from the body to help manage the symptoms of Wilson Disease.
- The main aim of this clinical trial to work out the remaining balance of copper and of molybdenum (another mineral found in the body) by measuring the amounts entering the body through food and drink and leaving the body in urine and faeces in Wilson Disease patients treated with the investigational medicine.
- This clinical trial will involve you staying at our private research facility in London Bridge (see below).
- You will receive a daily repeat dose of the investigational medicine for 28 days and you may subsequently receive a higher dose ( given daily) of the investigational medicine for the next 11 days (depending on the results of the first 28 days).
- Your blood, urine, and faeces samples will be collected for the clinical trial.
- During your in-house stays, you will receive standard meals each day including breakfast, lunch, evening meals and snacks, served at specific times. You will have to consume all your meals and snacks.
- During your in-house stays, you will have to drink a minimum of 1.5 L of water each day.
If you are interested in participating in the trial,
- You will need to attend a screening appointment so we can determine if you are suitable to take part in the trial. At this appointment we will assess your suitability by doing a number of tests including taking blood, checking you heart and doing a physical exam.
- If your screening visit results show that you are a good candidate for the clinical trial, you will be invited to take part in the trial, and you will be required to attend 2 in-house stays and 2 visits as below.
- First in-house stay of 17 days / 16 nights, followed by one outpatient visit for a number of safety assessments.
- Second in-house stay of 18 days / 17 nights followed by one follow-up visit 14 days after you are discharged from the unit. Alternatively, you will have the option to stay at our research facility between the 2 in-house stays, in which case you will stay for a total duration of 48 days. If you choose this option, you will have 1 in-house stay and 1 follow-up visit as below.
- 1 in-house stay of 48 days / 47 nights.
- 1 follow-up visit 14 days after you are discharged from the unit.
Who can take part?
We will check your suitability for the clinical trial using the following criteria:-
- You have Wilson Disease and are aged 18 years or older.
- You are a patient who, in the opinion of a medical expert, (your specialist doctor) might benefit from treatment with the investigational medicine.
- If you are currently taking another medication for Wilson Disease, you are willing to work with your specialist doctor to safely stop it, for approximately 4 days prior to start of taking the investigational medicine once you have attended the research facility for your first in house stay.
- If you are currently taking zinc treatment, you are willing to work with your doctor to safely stop it from 30 days prior to the screening visit.
- You must be healthy with no underlying medical conditions (except Wilson Disease) that may either interfere with participation in the study, and/or put you at any significant risk.
- You are willing to complete all the standardised copper-controlled meals, we provide you, served at specific times throughout your in-house stays.
- You are willing to comply with a low copper dietary requirement during the outpatient period.
- You are willing to take part in a gentle exercise regime during your residential stay. We can provide more details of this when we speak to you about the study.
- You are not pregnant or planning to become pregnant.
- You must not test positive for alcohol or drugs or show any evidence of drug or alcohol abuse (Alcohol abuse is defined as a regular weekly intake of more than 14 units).
- Females: You must be willing to use appropriate contraception, starting from one complete menstrual cycle prior to the first day of dosing until at least 3 months after last clinical trial visit.
- Males: You must be willing to use appropriate contraception, starting from screening until at least 3 months after last clinical trial visit.
A full list of acceptable contraceptive methods will be discussed in full by a member of the recruitment team and a clinical trial doctor during screening.
Clinical trial payment
In recognition of the time involved in taking part in this clinical trial, you will receive £6,420 (£5,420 clinical trial payment and £1,000 bonus) on completion of the clinical trial provided you comply fully with all the clinical trial requirements. This amount is based on the anticipated clinical trial plan and will be adjusted pro-rata (i.e. same amount of money paid per unit of time), should we invite you to attend extra visits.
Clinical trial dates
Screening now. For further details on trial dates, contact a member of the recruitment team on 020 7042 5800 (select option 1) or register to receive a call.
You may be required to remain resident in the unit until the resolution of any safety issues, after which you will be discharged from the unit.
The contents of this page have been approved by an ethics committee. Any response to this advertisement will be recorded. Your response will not place you under any obligation to participate in this trial.