RD 784/34991 – Simbec-Orion Skip to content

HELP CLINICAL RESEARCH TODAY

If you are a healthy male or female, aged between 18 and 55, then you may be eligible to participate in a research study investigating a potential new treatment for conditions such as epilepsy, spasticity, anxiety and other conditions of the central nervous system.

Maximum inconvenience payment up to £2460.

study information

Simbec-Orion Clinical Pharmacology will soon be running a study to investigate a potential new drug called ENX-102.

The main objectives of this study are as follows:

  • To determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of ENX-102 when it is administered as a single dose at different dose strengths on one occasion.
  • To investigate the amount of ENX-102 in the blood after a single oral dose, how the amount of ENX-102 in the blood changes over time, and whether there are differences in the amount of ENX-102 in the blood when ENX-102 is given at different dose strengths.

ENX-102 is being developed for the treatment of epilepsy, spasticity (a muscle disorder where muscles stiffen and spasm), anxiety, and other conditions of the central nervous system (brain and spinal cord). Currently, there are many different treatment options available for the conditions of the central nervous system mentioned above; however, these treatments are not very effective for long-term management of these conditions and can cause a number of significant side effects. Therefore, there is a need to develop new treatments which could be more effective in long-term treatment and have less associated side effects.

The purpose of the study is to evaluate the safety and tolerability of ENX-102, and to measure the amount of ENX-102 in the blood after it is given as a single dose on one occasion. The study will consist of 6 planned groups of 8 participants: with participants in each group receiving a different dose strength. During the study, you will be required to stay at the Simbec-Orion clinical unit for a minimum period of 5 days (4 overnight stays). It is possible that, based on the information obtained from previous group(s), the treatment period may be extended by an additional 1 or 2 days which would increase the number of overnight stays to a maximum of 6 instead of 4. Therefore, if you are screening for participation in Groups 2-6, you should ensure that you are available to complete all visits up to Day 6 if this is required.

study timeline

*As described in the study information section above, the treatment period may be extended up to a maximum of an additional 2 days which would increase the number of overnight stays to 6 instead of 4.

APPLY NOW

Thank you for your interest in joining our panel of healthy volunteers, please register by completing 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 – 35 kg/m2 to participate in this trial. 

Your BMI = [ Field17 / ( Field53 * Field53 ) ]

1. 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.)
2. Have you been diagnosed or tested positive for Coronavirus/COVID-19 within the last month?
3. Are you registered with a GP?(must be a UK resident for at least 1 year)
4. Are you taking any prescribed or repeat medication from a GP or a chemist?(including any over-the-counter medications, vitamins or supplements)?
5. 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)?
6. Do you have a history of any neurological conditions such as epilepsy or history of any trauma/infections of the brain e.g. meningitis?
7. Have you been diagnosed with a sleep disorder in the last 6 months or have any current history of sleep disturbance/are currently employed as a shift worker where normal working hours overlap with a typical sleep period?
8. Have you had any history of suicidal behaviour in the last 2 years?
9. Have you taken part in a clinical trial of an un-marketed drug in the last 90 days or 3 months?
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?(including vapes and eCigarettes)
12a. Have you smoked or used any nicotine products within the last 90 days?
13. Have you donated more than 500 mL of blood in the last 30 days or lost more than 1200 mL of blood in the last 4 months?
14. Do you drink alcohol?
14a. Do you consume more than 14 units per week?(For example, a can of beer/cider/lager is approximately 2 units)
15. Have you had any body piercings or tattoos in the last 3 months?
16. Are you currently using some form of contraception (if you are male with a female partner of child-bearing potential or if you are a female of child-bearing potential)?
16a. Please select which form of contraception

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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