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Clinical trial summary
We are conducting a clinical trial for an investigational drug that could be used to treat people with mood-related disorders such as post-traumatic stress disorder (PTSD) and movement disorders like Tourette syndrome. Mood-related disorders are conditions that affect a person’s emotional state and mood.
The investigational drug will be taken orally as a liquid (via mouth) either as a powder mixed with liquid or as a flavoured emulsion, with or without food. The trial includes several safety assessments that will help us to measure how the body processes the medicine in powder form versus emulsion form, to determine whether food affect show long the drug stays in the bloodstream, and how safe and well-tolerated the drug is.
You will be paid for your time if you take part in this clinical trial.
If you are interested in participating in the trial:-
Part 1
- 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 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.
- The trial involves 3 in-house period stays of approximately 5 days / 4 nights in our clinical research unit.
- After your stay with us you will be required to return for a further 8 follow-up visits. This means the whole process takes approximately 12 weeks from your screening visit through to your last follow-up visit.
- You will have to attend the unit on approximately 12 occasions from the screening appointment to the last follow-up.
- During your stay, you will receive a single dose of the investigational drug orally (via mouth). You will receive the investigational drug on 3 different occasions (at each stay) under fasting or fed conditions. The drug will be given in two different formulations, flavoured emulsion and powder mixed with liquid. During your stay, we will conduct several assessments to measure how the body processes the investigational drug in each formulation (powder vs emulsion) and to determine whether food affects how long the drug stays in the bloodstream.
Who can take part?
We will check your suitability for the clinical trial using the following criteria:-
- You are a male or female of non-childbearing potential aged 18-50 years old.
- You must weigh over 50kg and have a BMI between 18 and 30 kg/m2, inclusive, at screening.
- You must not have any acute illness or fever within the last 14 days before Day 1.
- You must not use tobacco or nicotine products within 6 months before Day 1.
- You must not test positive for drugs of abuse or alcohol at screening or admission or show any evidence of alcohol or drug abuse within the last 2 years.
- You must not have undertaken any strenuous physical activity 7 days before screening, admission and follow-up visits.
- You must not use over-the-counter medications within 14 days of Day 1.
- You must not use herbal remedies or dietary supplements within 30 days of Day 1.
- You must not have had general anaesthesia within the last 3 months.
- Female participants of childbearing potential are not eligible for this trial.
- Male participants with female partners must be willing to use appropriate barrier contraception for the duration of the study until at least 3 months after the final study visit.
A member of our recruitment team will give you a full list of do’s and don’ts if you are interested.
Clinical trial payment
In recognition of the time involved in taking part in the trial, you will receive £3,150 (£2100 clinical trial payment and £1050 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 period 1: 19th November
Dismissal: 23nd November
Follow-up visits: 26th and 29th November
Admission period 2: 3rd December
Dismissal: 7th December
Follow-up visits: 10th and 13th December
Admission period 3: 17th December
Dismissal: 21st December
Follow-up visits: 24th, 27th, 31st December 2024 and 8th January 2025
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: C23046_AUG-2024 (email_website_advert text)
