RD 785/35321 – Simbec-Orion Skip to content

HELP CLINICAL RESEARCH TODAY

We are looking for healthy males or females aged between 18 and 50, that may be eligible to participate in a clinical trial investigating a new type of formulation being developed for the treatment of sickle cell disease.

Maximum inconvenience payment of £1720.

study information

Simbec-Orion Clinical Pharmacology will soon be running a study to investigate hydroxycarbamide in 2 different forms: hydroxycarbamide oral dispersible tablets (test product) in comparison with a hydroxycarbamide Siklos® oral film-coated tablet (reference product). 

The main objectives of this study are as follows: 

  • To investigate the concentration of hydroxycarbamide oral dispersible tablets (test product) in the blood, how this concentration changes over a period of time and to evaluate whether there are differences in the concentration of hydroxycarbamide in the blood between the hydroxycarbamide oral dispersible tablets (test product) and the hydroxycarbamide Siklos® oral film-coated tablet (reference product). 
  • To evaluate the bioequivalence (assessment of whether products can be considered the same in terms of effect) of hydroxycarbamide as an oral dispersible tablet (test product) in comparison with the hydroxycarbamide Siklos® oral film-coated tablet (reference product). 
  • To determine the safety and tolerability (extent to which side effects of a drug can be tolerated) of hydroxycarbamide oral dispersible tablets (test product) in comparison with a hydroxycarbamide Siklos® oral film-coated tablet (reference product) when they are administered as a single dose of 1000 milligrams (mg). 

Hydroxycarbamide is a marketed product which is used for the treatment of a group of red blood cell diseases known as sickle cell disease. Hydroxycarbamide is currently only available in the form of oral tablets/capsules to swallow or in the form of a solution which can be swallowed. As sickle cell is a lifelong condition, these forms of hydroxycarbamide are not always best suited for administration in children or in individuals who may have difficulties in swallowing tablets and therefore, there is an unmet need to develop potential new forms of hydroxycarbamide in alternative dosage forms which could be more suitable for these populations without affecting the effectiveness of the treatment. 

The study will consist of 3 planned groups of 10 participants: with participants in each group receiving both the test and the reference product across 2 treatment periods at the same dose strength (1000 mg). In this study, participants will be given hydroxycarbamide in 2 different forms: the test product as a hydroxycarbamide oral dispersible tablet (to be dissolved in water) and the reference product (hydroxycarbamide Siklos® oral film-coated tablet) as an oral tablet (to be swallowed with water). 

Blood samples will be taken at set time points throughout the study in order to measure the concentration of hydroxycarbamide in the blood. We will compare the results between the test and reference product to determine if there are any significant differences in the safety of hydroxycarbamide, the concentration of hydroxycarbamide in the blood, how this concentration changes over time and whether the way in which the hydroxycarbamide is administered has any significant impact on these factors. 

The purpose of the data generated in this study is to provide important information which will go on to support drug marketing applications for the test product so that this new form of hydroxycarbamide may be marketed as an alternative dosage form to the currently available hydroxycarbamide products. 

If you participate in this study, you will be required to stay at the Simbec-Orion clinical unit for a maximum period of 3 days (2 overnight stays) per treatment period followed by a post study follow-up visit 1-3 days after the last dose of hydroxycarbamide. The 2 treatment periods will be separated by a minimum period of 3 days (72 hours) and you should therefore ensure that you are able to commit to completing all visits before agreeing to participate in this study. 

study timeline

If you complete this study, you will receive a maximum inconvenience payment of £1720. 

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 18-50 to participate in this trial. 

Your BMI must fall within the range of 18.0 – 29.9 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. Have you received a vaccine (including any vaccine for Coronavirus/COVID-19) within the last 28 days?(must be a UK resident for at least 1 year)
4. Are you registered with a GP (must be a UK resident for at least 1 year)?
5. Are you taking any prescription or repeat medication from a GP or a chemist (including any over-the-counter medications, vitamins or supplements)?
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 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?
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 3 months?
15. Are you currently using some form of contraception?(if you are a male or female of childbearing potential in a heterosexual relationship)?

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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