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DISCOVER A NEW WAY TO HELP

If you are a healthy male or female (of non-childbearing potential) aged between 18 and 55, then you may be eligible to participate in a clinical trial investigating a treatment being developed for Amyotrophic Lateral Sclerosis (ALS – also known as Motor Neurone Disease – MND).

Maximum Inconvenience Payment of £4950.

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study information

Simbec-Orion Clinical Pharmacology will soon be running a study to investigate the study drug, DNL343. 

The main objectives of this study are as follows: 

  • To determine if there any effects/interactions between DNL343 and itraconazole (ITZ – a drug commonly used in the treatment of different types of fungal infections), and to determine how ITZ affects the safety, tolerability (degree to which side effects of a drug can be tolerated) and concentration of DNL343 in the blood. 
  • To determine the safety and tolerability of DNL343 when it is administered on two occasions; once when it is taken alone and when it is administered in the presence of ITZ. 
  • To investigate the concentration of DNL343 in the blood, and to measure how this concentration differs when DNL343 is taken on its own versus in combination with ITZ. 

DNL343 is being developed as a potential treatment for Amyotrophic Lateral Sclerosis (ALS – also known as motor neurone disease (MND)). ALS is a long-term progressive condition of the nervous system whereby there is an accumulation of proteins in certain cells in the brain and nervous system known as motor neurones, leading to death of these cells. These cells control and manage the signals from the brain to the body which control movement and other key muscle functions. Therefore, as these cells die, symptoms begin to appear. ALS is associated with muscle weakness in limbs, difficulties in speech and swallowing and eventually loss of all muscle function including the muscles controlling breathing. 

There is currently no known cure for ALS, and available treatments are not effective in managing the overall symptoms of the disease, nor do they slow or stop the progression of the disease. Therefore, there is an unmet need to develop therapies which actively seek to target the underlying causes of the disease and provide a more effective overall treatment. 

This study is classed as a drug-drug interaction study. This means that you will be given a drug which has known effects and a known method of breakdown (metabolism) in the body (ITZ) and given the study drug (DNL343) to determine if there is any effect or interaction between the drugs in the body and whether administration of ITZ affects the safety, tolerability and concentration of DNL343 in the blood. 

The purpose of the study is to evaluate the safety, tolerability and effect of ITZ on the concentration of DNL343 in the blood to determine as to whether ITZ (and other drugs which act in the same way as ITZ) have the potential to interact with DNL343, thereby affecting the desired effect of DNL343 in the body. 

In the study, participants will take a single dose of DNL343 (40 milligrams – mg) on Day 1, followed by a 200 mg dose of ITZ twice daily on Day 15 (200 mg per dose), then once daily (200 mg) from Days 16-17, then 200 mg of ITZ twice daily on Day 18 (200 mg per dose), and then once daily from Days 19-28 (200 mg per dose) in addition to taking a single dose of DNL343 (40 mg, taken together with the morning dose of ITZ) on Day 18. 

If you participate in this study, you will be required to complete the following visits: 

  • Part 1 Treatment Period (Day -1 to Day 3 – total of 3 overnight stays) 
  • Return Visits (Days 5, 7 & 11 – single day visits – no overnight stays) 
  • Part 2 Treatment Period (Day 14 to Day 28 – total of 14 overnight stays) 
  • Return Visit (Day 31 – single day visit – no overnight stays) 
  • Post-Study Follow Up Visit (Day 45 – single day visit – no overnight stays) 

You should therefore ensure that you are able to commit to completing all visits before agreeing to participate in this study. 

Blood samples will be taken at set time points throughout the study in order to measure the concentration of DNL343 in the blood and to evaluate how the concentration of DNL343 differs when it is taken alone versus when it is taken with ITZ. 

The purpose of the data generated in this study is to provide further information and guidance to support the study sponsor in the development of the study drug DNL343. 

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study timeline

If you complete this study, you will receive a maximum inconvenience payment of £4950. 

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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 18-55 to participate in this trial. 

Your BMI must fall within the range of 18.5 – 30.0kg/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. Have you received a COVID-19 vaccination in the last 28 days?
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. Have you been hospitalised i.e., required an overnight stay during the last 4 weeks?
8. Do you have a history of any conditions of the brain, including history of stroke, cognitive impairment, seizures within the last 5 years, or head injury with loss of consciousness within the last 2 years?
9. Have you taken part in a clinical trial of an un-marketed drug in the last 90 days?
10. Have you taken part in a clinical trial of an un-marketed or marketed drug classed as biologic in the last 6 months?
11. Have you taken part in a clinical trial of a marketed drug in the last 30 days?
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 3 months?
13. Have you donated more than 500 mL of blood in the last 30 days?
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 (unless you are a female of non-childbearing potential, single with no current sexual partners or in an exclusively homosexual relationship)?
16a. If “Yes” answered selected options available to select:

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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