RD 783/34917 – Simbec-Orion Skip to content

HELP CLINICAL RESEARCH TODAY

If you are a healthy male aged between 18 and 55, then you may be eligible to participate in a clinical trial investigating a treatment being developed for a range of different diseases associated with fibrosis and inflammation.

Various inconvenience payments ranging from £1625 to £2650.

study information

Simbec-Orion Clinical Pharmacology will soon be running a study to investigate a new drug called RXC007.

RXC007 is being developed for the treatment of a range of different diseases associated with fibrosis and inflammation. RXC007 is specifically being developed to treat a condition called idiopathic pulmonary fibrosis (IPF) but may also be utilised in the treatment of non-alcoholic steatohepatitis (NASH), liver and kidney disease.

Currently, there are limited treatment options available for this condition (IPF) which are considered long term and effective and therefore, there is an unmet need to develop potential new treatments which could be more effective.

 

The main objectives of this study are as follows:

  • To determine the safety and tolerability of RXC007 when it is administered as single and multiple doses at different dose strengths over a period of up to 14 days.
  • To investigate the concentration of RXC007 in the blood, how this changes over a period of time and to evaluate whether there are differences in the concentration between different dose strengths over time and between single or multiple doses.
  • To investigate the effect of food on the concentration of RXC007 in the blood and to investigate if there any effects/interactions between RXC007 and 2 other drugs (rosuvastatin and metformin).

PART A

Part A will consist of 6 planned groups of 6 participants: each group investigating a different dose strength starting at the lowest dose and gradually increasing in each group. In addition, one group in Part A will investigate the effect of food on the safety, tolerability and concentration of RXC007 in the blood by taking a single dose of RXC007 following an overnight fast and then following a high fat breakfast.

If you are in the non-food effect groups, you will be required to stay at the Simbec-Orion clinical unit for a maximum period of 5 days (4 overnight stays) followed by a post study follow-up visit and you should therefore ensure that you are able to commit to completing this.

If you are in the food effect group, you will be required to stay at the Simbec-Orion clinical unit for a maximum period of 5 days (4 overnight stays) per treatment period with approximately 4 weeks gap between the two treatment periods. Each treatment period is followed by a follow-up visit and you should therefore ensure that you are able to commit to completing this.

study timeline

Note: the current planned treatment period for all groups in Part A is up to a maximum of 4 overnight stays for each treatment period i.e. from Day -1 to Day 4. However, it is possible that following review of the data generated from each group in Part A that the length of the treatment period may be reduced by one day and therefore, the treatment period will only last from Day -1 to Day 3 (only 3 overnight stays).

If you are in the non-food effect groups and you complete this part of the study, you will receive a maximum inconvenience payment of £1625. If you are in the food effect group and you complete this part of the study, you will receive a maximum inconvenience payment of £2650.

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 18.0 – 32.0kg/m2 and have a minimum weight of 60kg 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 prescription 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 suffer from/have a history of gastro-intestinal conditions or surgeries?
7. Have you suffered from a serious infection in the last 3 months?
8. Have you taken part in a clinical trial of an un-marketed drug in the last 90 days or 3 months?
9. Have you taken part in a clinical trial of a marketed drug in the last 30 days?
10. Have you ever suffered from a serious allergic reaction or have a known severe allergy?
11. Do you smoke or use any nicotine products (including vapes and eCigarettes)?
11a. Have you smoked or used any nicotine products within the last 6 months?
12. Have you donated more than 450 mL of blood in the last 3 months?
13. Do you drink alcohol?
13. a. Do you consume more than 14 units per week? (For example, a can of beer/cider/lager is approximately 2 units)
14. Are you vegan or vegetarian or have any social, religious or cultural reasons which would prevent you from eating a high fat or standardised breakfast (high fat breakfast includes eggs, bacon, whole milk)?
15. Have you had any body piercings or tattoos in the last 3 months?

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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