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Clinical trial summary
We are conducting a clinical trial for an experimental drug that could be used to treat people with alcohol addiction and to better understand the disease and the associated health problems.
In this clinical trial, we are recruiting approximately 60 healthy participants aged 18 to 45.
We will observe if the experimental drug is safe, how long it stays in your blood and how it affects your heart activity.
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 in the trial. At this appointment, we you will undergo assessments including but not limited to taking 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 an in-house stay of 13 days / 12 nights in our clinical research unit.
- After your stay with us you will be required to return for a follow-up visit 3 to 7 days after discharge from the in-house stay. This means the whole process takes up to 54 days 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 3 times.
- During your stay with us you will receive multiple doses of the experimental drug as oral capsules (e.g. via the mouth) and we will conduct a number of assessments (like those we did at screening) to check how safe the experimental drug is, to help us understand how long it takes for your body to process the experimental drug and to check how the experimental drug affects your heart.
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 45 years (inclusive).
- You must have a Body Mass Index (BMI) between 18 and 30kg/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 admission or show any evidence of alcohol or drug abuse.
- You must not use prescription medication within 30 days of dosing (excluding hormonal contraceptives or hormone replacement therapy) or over-the-counter medications (including vitamins, herbal remedies, and dietary supplements) within 14 days of Screening.
- You must not have donated or lost more than 500ml or more blood products within 56 days of screening.
- 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 2 menstrual cycles before the first day of dosing and until 90 days after the last dose of the trial drug.
- Male participants must be willing to use appropriate barrier contraception during the trial and for at least 90 days after the last dose of the trial drug, 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 30 days of screening and until the last visit.
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 £2,650 (£1,766.67 clinical trial payment and £883.33 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
Admission: 8th December
Dismissal: 20th December
Follow-up visit: 26th December
Approval
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: C23026_MAR_2024 (email_website_advert text)
