RD 724/34949 – 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 treatment for conditions such as ulcerative colitis and rheumatoid arthritis.

Inconvenience Payment Part A £3945

Inconvenience Payment Part B £3000

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study information

Simbec-Orion Clinical Pharmacology will soon be running a study to investigate a new drug called ABX464. ABX464 is specifically being developed for conditions such as ulcerative colitis (UC) and rheumatoid arthritis (RA). Ulcerative colitis is a long-term condition where the lower end of the digestive system (bowel) can become inflamed and form ulcers. Rheumatoid arthritis is a long-term condition that causes pain, swelling and stiffness in the joints. These are conditions broadly categorised as being associated with inflammation. Inflammation is a biological response of the tissues and cells in the body to harmful exposures such as bacteria and viruses or damaged cells through injury or trauma or through irritation to particular tissues.

In diseases associated with inflammation such as ulcerative colitis and rheumatoid arthritis, there is a dysfunction (abnormality of impairment) in the immune system which causes uncontrolled inflammation in the tissues leading to the long-term chronic symptoms that individuals with these conditions experience.

This study is classed as a drug-drug interaction study. This means that you will be given one of two drugs which have known effects and a known method of breakdown (metabolism) in the body (caffeine or fluvoxamine) and then given the study drug (ABX464) to determine if there is any effect or interaction between the drugs in the body and whether administration of caffeine or fluvoxamine affects the safety and tolerability of ABX464.

In addition, the information gathered in relation to these interactions will provide information as to how ABX464 is broken down or metabolised in the body.

The purpose of this is to support the study sponsor in developing guidance as to how the ABX464 product should be administered in future clinical studies of the product and to develop an understanding as to how ABX464 is metabolised in the body.

This study will be split into 2 separate parts: Part A & Part B.

The purpose of Part A is to evaluate the safety, tolerability and effects and interactions of ABX464 when it is given with and without caffeine. In Part A, participants will take an oral caffeine tablet on 3 occasions (Day 1, 4 & 17) at a strength of 50 milligrams (mg) and in addition take ABX464 once daily for a period of 14 days (Day 4-17) at a strength of 50 mg in a capsule form. In Part A, blood samples will be taken at set time points throughout the study in order to measure the concentration of caffeine in the blood, how this changes over time and how this changes when participants are taking ABX464 at the same time.

The purpose of Part B is to evaluate the safety, tolerability and effect of fluvoxamine on the concentration of ABX464 in the blood to determine as to whether ABX464 is broken down (metabolised) via the same process as fluvoxamine. In Part B, participants will take 2 single doses of ABX464 (one on Day 1 and one on Day 11) at a strength of 50 milligrams (mg) per dose in a tablet form in addition to taking a single dose of fluvoxamine once a day for 10 days (Day 2 to 11) at a strength of 100 mg in a tablet form. As this drug is associated with withdrawal symptoms, participants will then continue to take fluvoxamine for a further period of 14 days (one 50 mg tablet once daily for 7 days followed by 25 mg (half of 50 mg tablet) once daily for 7 days). In Part B, blood samples will be taken at set time points throughout the study in order to measure the concentration of ABX464 in the blood, how this changes over time and how this differs with and without fluvoxamine

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study timeline

PART A TIMELINE:

SCREENING
VISIT

  • A short visit to Simbec-Orion within 28 days of the planned first dose (Day 1).

  • During this visit, assessments will be performed to determine if you are suitable to participate in the study.

TREATMENT PERIOD
(DAY -1 TO DAY 19)

  • You will be required to attend from the day before dosing (Day -1) for baseline assessments and will stay in the clinic until Day 6.

  • On Days 1 & 4, you will take 50 mg of caffeine and take the first dose of ABX464 on Day 4.

  • From Days 7-16, you will return to the unit to receive the daily dose of 50 mg of ABX464 once a day.

  • On Day 16, you will return to Simbec-Orion in the afternoon after your morning dose and stay in the unit until Day 19.

  • On Day 17, you will take the final doses of ABX464 and caffeine together.

  • On Day 19, you will leave Simbec-Orion.

POST STUDY
FOLLOW UP VISIT

  • Approximately 10-14 days after the last dose of ABX464 and caffeine, you will be required to attend Simbec-Orion for a final follow up visit.

  • The visit will require some final assessments and provided that these are okay, your participation in the study will be complete.

If you complete this study, you will receive a maximum inconvenience payment of £3945. You should note that this payment will be split into 2 parts: £500 after completion of the Day 6 visit and then the remaining £3445 after completion of the post-study follow up visit.

PART B TIMELINE:

SCREENING
VISIT

  • A short visit to Simbec-Orion within 28 days of the planned first dose (Day 1).

  • During this visit, assessments will be performed to determine if you are suitable to participate in the study.

TREATMENT PERIOD
(DAY -1 TO DAY 19)

  • You will be required to attend from the day before dosing (Day -1) for baseline assessments and will stay in the clinic until Day 2.

  • On Day 1, you will take the first dose of 50 mg of ABX464 and on Day 2 you will take the first dose of 100 mg fluvoxamine.

  • From Days 3-10 you will return to the unit to receive the daily dose of 100 mg fluvoxamine.

  • On the afternoon of Day 10 (after your fluvoxamine dose), you will return to Simbec-Orion and stay in the unit until Day 12.

  • On Day 11, you will take the final dose of ABX464 with fluvoxamine.
    Following Day 12, you will continue to take fluvoxamine for a period of 14 days; 50 mg once a day for 7 days and 25 mg once a day for 7 days.

POST STUDY
FOLLOW UP VISIT

  • Approximately 3-5 days after the last dose of fluvoxamine, you will be required to attend Simbec-Orion for a final follow up visit.

  • The visit will require some final assessments and provided that these are okay, your participation in the study will be complete.

If you complete this study, you will receive a maximum inconvenience payment of £3000. You should note that this payment will be split into 2 parts: £500 after completion of the Day 12 visit and then the remaining £2500 after completion of the post-study follow up visit

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Thank you for your interest in joining our panel of healthy volunteers, please register by completing the below form.

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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. 

In order to participate in this trial, your BMI must fall within the range of 18.5-30.0 kg/m2 and your weight must be at least 55kg or above. 

Your BMI = [ Field17 / ( Field55 * Field55 ) ]

Which part of the trial are you applying for?
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 with 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?
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. Do you suffer from regular headaches (i.e., weekly or more frequent)?
8. Do you suffer from or have a history of depression and/or anxiety? (PART B ONLY)
9. Have you taken part in a clinical trial in the last 90 days or 3 months?
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 e-Cigarettes)?
11.a. Have you smoked or used any nicotine products within the last 6 months?
12. Have you donated 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. Have you had any body piercings or tattoos in the last 6 months?
15. Are you currently using some form of contraception?
16. Are you currently pregnant, lactating or breastfeeding (females only)?

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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