Clinical trial summary
We are conducting a clinical trial for an investigational medicine that could be used to replace the current treatment option for Wilson’s disease where the Pharmaceutical Company has increased the dose and modified the non-pharmaceutical ingredients in their already approved product by the UK Medical Health and Regulatory Agency (MHRA).
Wilson disease is a rare disease affecting 30 individuals for every million of the population. In the UK there are less than 2000 patients. The disease is caused by a build-up of copper in the body, leading to damage of the liver and nervous system.
The clinical trial involves taking tablets and repeated blood sampling to discover how the drug is absorbed, how it is processed by your body and how long it takes to remove the drug and its products from your body.
In this clinical trial we are recruiting up to 26 healthy participants aged 18 to 40 aiming to have a balance between males and females.
You will be paid for your time if you agree to take part in this clinical trial.
If you are interested in participating in the trial:-
- You will need to attend a screening appointment so we can check if you are suitable to take part. At this appointment, we will take blood, check your heart, and carry out a physical examination.
- If results from your screening appointment show you are suitable for the trial, you will be invited to take part.
- This will involve two separate in-house stays, each consisting of 4 days / 3 nights in our clinical research unit. The period between the in-house stays will be 5-10 days.
- After your stay with us you will be required to return for a follow-up appointment after the second in-house stay.
- This means the whole process takes approximately 7 weeks from your screening visit through to your final visit.
- In total, if you are included in the clinical trial you will come to the research unit 4 times.
- During the two in-house stays you will receive the investigational medicine and the existing medicine as oral tablets (e.g. via your mouth). You will receive one of the medicines during your first in-house stay. After a certain period, to ensure it is out of your system, you will then receive the other medicine during your second in-house stay. We will conduct several assessments (like those we did at screening) to check how well you tolerate the investigational medicine, to help us understand how long it takes for your body to process, and to compare it with the existing medicine.
Who can take part?
We will check your suitability for the clinical trial using the following criteria:-
- You are a male or female aged between 18 to 40 years (inclusive).
- You must have a body weight of over 50kg, and your Body Mass Index (BMI) is between 18.0 and 25.0 kg/m2 (inclusive).
- You must be healthy with no underlying medical conditions that may affect the trial or put you at any significant risk.
- You must not test positive for drugs of abuse or alcohol at screening or day -1 or show any evidence of alcohol or drug abuse.
- You must not use prescription (excluding hormonal contraceptives or hormone replacement therapy) within 30 days of dosing or over-the-counter medications (including herbal remedies and supplements) within 14 days of first study drug administration.
- You must not have donated or lost more than 450ml of blood within 16 weeks of the trial and are not planning to donate blood for 16 weeks after completing the trial.
- You must not be pregnant or breastfeeding.
- Female participants of childbearing potential, if sexually active with a male, must agree to the use of highly effective contraception starting at least 1 complete menstrual cycle before the first day of dosing and until 1 month after the last study dose.
- Male participants must be willing to use appropriate barrier contraception from the first day of dosing until 1 month after the last study drug administration, with female partners of child-bearing potential, including partners that are already pregnant.
- You must not use tobacco in any form (e.g., smoking or chewing) or nicotine products in any form (e.g., gum, patch, electronic cigarettes) within 6 months of screening, or test positive at screening.
A full list of do’s and don’ts will be given to you by a member of our recruitment team if you are interested and want to find out more.
Clinical trial payment
In recognition of the time involved in taking part in the trial, you will receive £1,250 (£833.33 clinical trial payment and £416.67 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
Call us on 0207 042 5800 to speak to a member of the recruitment team regarding trial dates.
Admission period 1: TBC
Admission Period 2: TBC
Follow-up visit: TBC
The contents of this email 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.
You may be required to remain resident in the unit until resolution of any safety issues, after which you will be discharged from the unit.
Ref: C23030_Jan-2024 (email_website_advert text)