RD 773/34286 – Simbec-Orion Skip to content

DISCOVER A NEW WAY TO HELP

If you are healthy and aged between 18 and 60 you can play an important part in developing a new treatment for migraines.

Inconveience Payment £1680

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study information

Simbec-Orion Clinical Pharmacology will soon be running a study to investigate a new drug called KL-00119 (active ingredient sumatriptan). Sumatriptan is a pharmaceutical product which is used in the management and treatment of migraines in adults with or without aura (vision changes, flashing lights etc). A migraine is a moderate to severe headache which is characterised as a severe throbbing sensation on one side of the head and can include symptoms such as feeling sick and increased sensitivity to light.

The objectives of this study are to evaluate and compare the bioequivalence (assessment of whether comparative products can be considered the same in terms of effect) and bioavailability (the degree and rate at which a substance (such as a drug) is absorbed into the body or is made available at the site of its’ desired effect) of KL-00119 as an oral mucosal film in comparison with marketed reference products (Imitrex and Imigran nasal sprays).

Additionally, the study will evaluate the effect of accidental swallowing of the KL-00119 product following an overnight fast and following consumption of a high fat breakfast on the levels of sumatriptan in the blood and provide general safety information for all 3 products.

In this study, sumatriptan will be given in 2 different forms; KL-00119 the test study drug will be administered as an adhesive oral film which is designed to stick to the lining of your cheek and allows the drug to be delivered directly into the bloodstream. Imitrex and Imigran the study reference products (which are already marketed sumatriptan products in the USA and UK respectively) will be administered in the form of a nasal spray which delivers the drug in a form of an aerosol spray into the nose where it is absorbed into the bloodstream.

In Part A, participants will be required to take a single dose of each of the products (KL-00119, Imitrex and Imigran) across 3 treatment periods and blood samples will be taken as set time points in each period to measure the levels of sumatriptan in the blood, how this changes over time and differs between the 3 products.

The purpose of the data generated in this study is to determine whether the KL-00119 oral film product is equivalent and as effective or more/less effective than currently marketed products for migraine treatments and to provide further information and guidance to support the study sponsor in development of the study drug

For each treatment period, you will be required to stay at the Simbec-Orion unit for period of 2 days per period (1 overnight stay per period) and should therefore ensure that you are able to commit to completing this

If you complete this study, you will receive a maximum inconvenience payment of £1680.

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study 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 PERIODS
1-3 (DAY -1 TO DAY 1)

  • Arrive at Simbec-Orion the morning before the first dose.

  • On Day 1, you will take either KL-00119, Imitrex or Imigran. After each product use, blood samples will be taken to measure the levels of sumatriptan in your blood.

  • Once all assessments are completed on Day 1, you will leave Simbec-Orion.

  • You will repeat the process until all 3 products have been used and there will be approximately 4 days between each product dose.

POST STUDY
FOLLOW UP VISIT

  • Approximately 5-7 days after the last dose, you attend Simbec-Orion for a follow up visit.

  • During this visit, assessments will be performed to ensure that it is safe for you to be discharged from the study.

  • Once this visit is complete, your involvement in the study is completed.

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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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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 18-60 to participate in this trial. 

In order to participate in this trial, your BMI must fall within the range of 19.0-30.0 kg/m2 and your weight must be at least 55kg or above. 

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

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. Have you taken part in a clinical trial in the last 90 days or 3 months?
7. Have you ever suffered from a serious allergic reaction or have a known severe allergy?
8. Have you ever suffered with regular serious migraines or headaches?
9. Are you a smoker?
9.a. Have you smoked in the last 6 months or used a nicotine product in the last 6 months?
10. Have you donated Blood in the last 3 months?
11. Do you drink alcohol?
11. a. Do you consume more than 14 units a week?
12. Have you had any body piercings or tattoos in the last 6 months?
13. Are you currently using some form of contraception?
14. Do you have any dietary restrictions that would prevent you from consuming standardised calorie-controlled meals?(Vegetarian/Vegan options available)

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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