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If you are a healthy male or female aged between 18 and 55, then you may be eligible to participate in a study investigating a new drug being developed for the treatment of Parkinson’s Disease (PD).

Inconvenience payment: £1775

CLINICAL TRIAL information

Simbec-Orion Clinical Pharmacology will soon be running a multi-part study to investigate this study drug.

The overall objectives of this study are to determine the safety, tolerability (degree to which side effects of a drug can be tolerated) and drug levels in the blood, urine and cerebrospinal fluid (CSF) when the study drug is given in different conditions e.g., following administration of different dose strengths, single and multiple doses and following optional evaluations which may include; in the presence and absence of food, effects associated with age, evaluating how the drug is distributed in the body (through using specialist imaging techniques) and evaluating these effects when the drug is administered in the patient population which the study drug is intended to treat.

 

 

 

The study drug is being developed for the potential treatment of Parkinson’s Disease (PD) which is a long-term progressive condition of the nervous system (which means it  gets worse over time) whereby there is an accumulation of proteins in certain cells in the brain, leading to death of these cells and is associated with symptoms like uncontrollable shaking and difficulty with balance and coordination. 

Despite the development of effective therapies for PD, these treatments only serve to manage the symptoms associated with PD and do not actually address the underlying causes of the disease. Therefore, there is an unmet need to develop therapies which seek to target the underlying causes of the disease. This study will be split into up to five separate parts, and you will only participate in one part of the study.

 

PART 1

The purpose of Part 1 is to evaluate the study objectives when the study drug is administered as a single dose at increasing dose strengths.

In addition in this study part, one group in Part 1 may investigate the effect of food on the study drug by taking a single dose of the study drug following an overnight fast and then following a high fat meal and some of the groups may investigate the levels of the study drug which are found in the CSF following completion of a lumbar puncture procedure. Part 1 will consist of one group of 6 participants up to 6 planned groups of up to 8 participants: each group will evaluate a different dose of the study drug starting at the lowest dose and gradually increasing in each group.

If you participate in this part of the study and are in the groups which are not undertaking the evaluations of food effect or measuring CSF i.e., only completing one treatment period, you will be required to stay at the Simbec-Orion clinical unit for a maximum period of 4 days (3 overnight stays) for the treatment period (Day -1 to Day 3), a return visit on Day 4 (if required), followed by a post study follow-up visit approximately 10 days following the dose of the study drug on Day 1.

If you participate in this part of the study and are in one of the groups completing the evaluations of food effect or measuring CSF i.e., completing two treatment periods, you will be required to stay at the Simbec-Orion clinical unit for a maximum period of 4 days (3 overnight stays) in each treatment period, complete up to two return visits on Day 4 of each treatment period (if required), followed by a follow-up visit approximately 10 days following the last dose of the study drug Day 1 in treatment period 2. 

 

Each dose in each treatment period will be separated by a period of 1-2 weeks; however this period may be longer so you will be informed as to whether you are participating in one of these groups and in addition, when you will need to return to complete the second treatment period.

You should also note that the timing of the post-study follow-up visit may be extended if the data generated during the study indicates that it is necessary to do so (you will be informed as to whether this is the case and subsequently when the post-study follow up visit will take place). Regardless of which group you are participating in, you should ensure that you are able to commit to completing all visits before agreeing to participate in this study.

If you are participating in the standard groups within Part 1 i.e., only completing one treatment period or you choose not to participate in the food effect and CSF groups (if your group is selected for these evaluations) and you complete this part of the study, you will receive a maximum inconvenience payment of £1775.

If you are in the food effect group i.e., completing two treatment periods and you complete this part of the study, you will receive a maximum inconvenience payment of £3250. 

If you are in one of the CSF sampling groups i.e., completing two treatment periods and you complete this part of the study, you will receive a maximum inconvenience payment of £3750.

CLINICAL TRIAL timeline

Standard Group Timeline:

Food Effect / CSF Timeline:

Screening Visit
Up to 35 days before trial commencement
Treatment Period
Four days in duration
Return Visit
If required, the day following discharge
Post Study Follow-up Visit
Day 11
Screening Visit
Up to 35 days before trial commencement
Treatment Period 1
Four days in duration
Return Visit
If required, the day following discharge
Treatment Period 2
Four days in duration, approx. 1-2 weeks later
Return Visit
If required, the day following discharge
Post Study Follow-up visit
Day 11

 

 

Note: for all groups in Part 1, you will be required to stay at the clinical unit for a maximum of 3 overnight stays per treatment period and if you are invited to complete the second treatment period, then the gap between the two doses in each treatment period will be approximately 1-2 weeks in duration. You will be informed as to whether your study group has been selected for either of the evaluations requiring completion of the second treatment period and therefore how long the study will be for you (including providing details of when you will need to return to complete the second treatment period as applicable). You should ensure that you are available to complete all required visits before agreeing to participate in the study.

In addition, the timing of the post-study follow up visit may be extended for all groups (with the exception of Group 1) if the data generated during the study indicates that it is necessary to do so (you will be informed as to whether this is the case and subsequently when the post-study follow up visit will take place). 

Excellent, can't fault the friendliness, professionalism and helpfulness of the medical, catering, cleaning and security staff. Thoroughly enjoyed participating in the study.
08 February 2023
Had a great time doing a trial, well treated, good facilities and had a good laugh with the other volunteers!
12 June 2019
Very friendly and efficient and thorough with the examinations, monitoring you constantly, making sure you are healthy and feeling well. I had a duvet day for 3 days, bliss.
21 May 2019

APPLY NOW

Thank you for your time. To register your interest in this trial please complete the below form.

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1 Step 1

To enable us to make an assessment of your suitability for a Clinical Trial, we will first need to gather some personal details relating to your health. To ensure your suitability for a Clinical Trial, by ticking the checkbox you agree that the information you have provided is accurate to the best of your ability. Your personal data will be stored on our database which is only accessible by Simbec Research Ltd and our service providers. To aid in your suitability assessment, we will only share with companies that support us delivering our services. Under the current European Data Protection Laws (GDPR), you have a number of rights in relation to your personal data such as the right to access, right to rectification and right to be forgotten where appropriate. Please note: if you have not been contacted within 3 months of applying for a trial, please assume you are ineligible and that your data has been deleted from our system, if you believe you are eligible for another one of our trials, please apply again in 3 months.

For more information regarding our commitment to your privacy, please read our Privacy-Policy

Agreement

You must be between the age of 18-55 to participate in this trial. 

Your BMI must fall within the range of 18.0 – 32.0kg/m2

Your BMI = [ Field74 / ( Field77 * Field77 ) ]

1. Have you previously screened for a trial at Simbec-Orion?If you have previously screened for a trial, you will likely be registered on our database. Please alternatively contact enrolmentservices@simbecorion.com to express interest.
2. Do you regularly use illegal drugs?(I.e., substances that are used for non-medicinal and leisure purposes. We test as part of the medical during both screening and the trial)
3. Have you been diagnosed with or tested positive for Covid-19 in the last month?
4. Have you received a COVID-19 vaccination, or any other type of vaccination in the last 35 days?If yes, please provide date and details
5. Are you registered with a UK GP Surgery/Practice?You must be a UK resident for at least one year
6. Are you taking any prescription or repeat medication from a GP or a chemist?Including any over-the-counter medications, vitamins or supplements
7. Do you suffer from or ever had any serious illnesses as diagnosed by your GP or health professional?(e.g., neurological, endocrinal, cardiovascular, pulmonary, haematological, immunologic, psychiatric, gastrointestinal, renal, hepatic and metabolic disease)
8. Do you suffer from/have a history of gastro-intestinal conditions or surgeries?
9. Have you taken part in a clinical trial of an un-marketed drug in the last 90 days/3months?
10. Have you taken part in a clinical trial of a marketed drug in the last 30 days?
11. Have you ever suffered from a serious allergic reaction or have a known severe allergy?
12. Do you smoke or use any nicotine products?This includes vapes and e-Cigarettes
12a. Have you used any of these products in the last 3 months?
12b. Have you used any type of smoking cessation medication in the last 3 months?I.e., gums, patches etc.
13. Do you currently intake excessive amounts of caffeine containing product (equivalent to more than 5 cups of coffee per day)?
14. Have you donated more than 450 mL of blood in the last 90days/3months?
15. Do you drink alcohol?
15a. Do you consume more than 14 units per week?For example, a can of beer/cider/lager is approximately 2 units
16. Have you had any body piercings or tattoos in the last 3 months?
17. Do you have any dietary restrictions (i.e., vegan/vegetarian, medical, social, cultural or religious) which would prevent you from consuming standardised or high-fat meals (including meat, gluten and dairy products) or from consuming gelatine?
18. Are you currently using some form of contraception (if you are a male or female of childbearing potential in a heterosexual relationship)?
18a. Please select from the following:

Thank you for your time and interest, but unfortunately based on your answer, you would be unable to participate in this trial at this time. But please feel free to fill out a general application form or keep a lookout for other clinical trials we may be recruiting for, as you may be eligible to help in a different trial

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