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DISCOVER A NEW WAY TO HELP

If you are a healthy male or female (of non-childbearing potential) aged between 18 and 55, then you may be able participate in clinical trial investigating a new drug being developed for the potential treatment of a range of diseases with the central nervous system. 

Study Payment Between £3730 – £5380

Plus Travel Expenses

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CLINICAL TRIAL information

Simbec-Orion Clinical Pharmacology will soon be running a two part study to investigate a drug called MDI-26478. 

The overall objectives of the study are to determine the safety, tolerability (degree to which side effects of a drug can be tolerated) and concentration in the blood of the study drug when evaluated in different conditions i.e., different doses and following administration of single and multiple doses.

The study also aims to evaluate the effect of the study drug on the body, through the performance of different types of cognitive testing (to measure changes in your skills associated with memory, attention and decision making) and specific imaging procedures of the brain.

Blood samples will be taken at set time points throughout the study in order to measure the concentration of MDI-26478 in the blood. In the context of the whole study, we will analyse the results from each of the groups and each study part and combine this information in order to better understand how MDI-26478 works in the body and assess how the levels of MDI-26478 change over time when MDI-26478 is administered at different doses and as single and multiple doses.

MDI-26478 is being developed as a potential treatment for a range of disorders associated with the central nervous system (CNS – brain and spinal cord), including schizophrenia (the main focus for this study).

To date, 54 volunteers have participated in this trial. 

The purpose of Part A is to evaluate the study objectives when MDI-26478 is given as a single dose on one occasion at different dose strengths.

Part A will consist of 5 planned groups of up to 8 participants (with the option to include up to 2 additional groups of up to 8 participants each): each group will evaluate a different dose of MDI-26478 starting at the lowest dose and gradually increasing in each group.

Each group will receive MDI-26478 or a placebo (which contains no active drug) in the form of an oral capsule (or multiple capsules dependent on dose strength).

If you participate in this part of the study, you will be required to stay at the Simbec-Orion clinical unit for a period of 4 days (3 overnight stays – Day -1 to Day 3) for the treatment period, followed by a post-study follow-up visit 5-7 days following the last dose of MDI-26478.

You should therefore ensure that you are able to commit to completing all visits before agreeing to participate in this study.

 

The purpose of Part B is to evaluate the study objectives when MDI-26478 is given as multiple doses once a day over a period of up to 14 days at different dose strengths. 

Part B will consist of up to 4 planned groups of up to 8 participants (with the option to include 1 additional group of up to 8 participants): each group will evaluate a different dose based on doses which have been evaluated in Part A of the study (where single doses at different doses were given). 

Each group will receive MDI-26478 or a placebo (which contains no active drug) in the form of an oral capsule (or multiple capsules dependent on dose strength).

If you participate in this part of the study, you will be required to stay at the Simbec-Orion clinical unit for a period of 17 days (16 overnight stays – Day -1 to Day 16) for the treatment period, followed by a post-study follow-up visit 5-7 days following the last dose of MDI-26478. 

Note*: The current planned treatment period for all groups in Part B is 16 overnight stays for the treatment period i.e., from Day -1 to Day 16. However, it is possible that following review of the data generated from Part A and each Part B group, that the length of the treatment period may be reduced to a minimum of 9 overnight stays (from Day -1 to Day 9) or any number of days in between this range. You will be told whether this change is applicable to your group but should ensure that you are available to complete the 16 overnight stays before agreeing to participate in the study.

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CLINICAL TRIAL timeline

Please note – we are anticipating further dates for this trial in the coming weeks. If you wish to apply in the meantime, your details will be added to the study contact list, and we will be in touch when new dates become available. 

 

 

CLINICAL TRIAL timeline

Please note – we are anticipating further dates for this trial in the coming weeks. If you wish to apply in the meantime, your details will be added to the study contact list, and we will be in touch when new dates become available. 

APPLY NOW

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

OR to speak to a member of the Enrolment Team for more information or regarding any questions or queries please ring 0800 691995 and please select option 1. Alternatively drop us an email: enrolmentservices@simbecorion.com 

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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 = [ Field74 / ( Field77 * Field77 ) ]

Your BMI must fall within the range of 18.0 – 32.0kg/m2, and your weight must be between 50-100kg

Have you previously attended a Screening appointment at Simbec-Orion?
1. Do you regularly use substances that are used for non-medicinal and leisure purposes. We test as part of the screening assessments for all our trials?(A urine sample will be collected for drugs of abuse testing at screening (Alcohol, amphetamines, barbiturates, benzodiazepines, cannabinoids/tetrahydrocannabinoids (THC), cocaine, methadone, and opiates etc)
2. Have you been diagnosed or tested positive for Coronavirus/COVID-19 within the last month?
3. Have you received a COVID-19 vaccination or any vaccination in the last 60 days?
4. Are you registered with a UK GP Surgery/Practice (for at least 6-12 months) ?
5. Are you currently taking any prescription or repeat medication from a GP or a chemist within the last 28 days?
6. . 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)?
7. Do you suffer from/have a history of gastro-intestinal conditions or surgeries?
8. Have you taken part in a clinical trial of an un-marketed drug in the last 90 days/3months?
9. Have you taken part in a clinical trial of a marketed drug in the last 30 days/1 month?
10. Have you ever suffered from a serious allergic reaction or have a known severe allergy?
11. Do you smoke or are you a current cigarette user?
11a. Do you or have you used any nicotine products (including, nicotine vapes, e-cigarettes and any nicotine replacement therapy) within the last 6 months?
12. Have you donated more than 450 mL of blood in the last 90days/3months?
13. Do you drink alcohol?
13a. Do you consume more than 14 units per week? (For example, a can of beer/cider/lager is approximately 2 units)
14. Have you had any body piercings or tattoos in the last 28 days?
15. Which of the following criteria do you meet?

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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