RD 777/34920 – Simbec-Orion Skip to content

HELP CLINICAL RESEARCH TODAY

If you are a healthy male or female (of non-childbearing potential) and aged between 18 and 55, you can play an important part in developing a new treatment for a disease called Leishmaniasis.

Inconveience Payment Part A £4120

study information

Simbec-Orion Clinical Pharmacology will soon be running a study to investigate a new drug called DNDI-0690. DNDI-0690 is being developed for the treatment of a disease called leishmaniasis. This disease is caused by a parasite (an organism which lives on or in another organism and uses the host to survive) which infects the body of female sandflies. These types of fly bite humans, and this causes the parasite to be passed on and infect a human host. This disease is commonly found in countries which are less developed with high rates of poverty, malnutrition and poor housing conditions. There are 3 main forms of the disease which can cause symptoms ranging from breakdown of the tissues in the mouth, nose and throat to ulcers and scarring of the skin to fever, weakness and weight loss which can be fatal if left untreated.

Currently there are treatment options available for this disease, but these are not the most effective as they require a long duration of treatment, are associated with a number of side effects and are generally only effective against one form of the disease. Therefore, there is an unmet need to develop potential new treatments and therapies which could be more effective, and which could be used to combat all forms of the disease with one combined treatment.

The study will be split into 3 separate parts: Part A, Part B and Part C.

The purpose of Part A is to evaluate the safety, tolerability and concentration of DNDI-0690 in the blood and urine when it is given at different dose strengths once or twice a day for 10 days

In Part A of the study, there will be a maximum of 4 groups. Each group will consist of 9 participants; 6 who will receive the active drug DNDI-0690 in capsule form and 3 who will receive a placebo (containing no active drug).

Once each group has been completed, there will be a review of the data to determine what the appropriate dose should be for the next dosing group. As part of this data review, it may also be decided that the study drug should be given twice per day instead of once per day.

Within each group, blood and urine samples will be taken at set time points throughout the study in order to measure the concentration profile of DNDI-0690 in the blood and urine. We will compare the results from each of the groups to determine if there are any significant differences in the safety profile of DNDI-0690, the concentration of DNDI-0690 in the blood and urine and how this changes over time.

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

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
(DAY -2 TO DAY 12)

  • Arrive at Simbec-Orion 2 days before the first dose. From Days 1-10, you will take DNDI-0690 or placebo once or twice a day (if a two dose regimen is required).
    Once all assessments are completed on Day 12, you will leave Simbec-Orion.

  • 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.

POST STUDY FOLLOW UP VISIT

  • Approximately 14 days after the last dose of DNDI-0690 you will attend Simbec-Orion for a follow up 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.

If you complete this part of the study, you will receive a maximum inconvenience payment of £4120

APPLY NOW

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

[[[["field23","equal_to","Yes"],["field24","equal_to","Yes"],["field25","equal_to","No"],["field26","equal_to","Yes"],["field27","equal_to","Yes"],["field28","equal_to","Yes"],["field29","equal_to","Yes"],["field30","equal_to","Yes"],["field49","equal_to","Yes"],["field33","equal_to","Yes"],["field35","equal_to","Yes"],["field36","equal_to","Yes"],["field37","equal_to","Yes"],["field16","less_than","18"],["field16","greater_than","30.1"],["field17","less_than","60"]],[["show_fields","field44"]],"or"],[[["field23","equal_to","No"]],[["show_fields","field24"]],"and"],[[["field24","equal_to","No"]],[["show_fields","field25"]],"and"],[[["field26","equal_to","No"]],[["show_fields","field27"]],"and"],[[["field27","equal_to","No"]],[["show_fields","field28"]],"and"],[[["field29","equal_to","No"]],[["show_fields","field30"]],"and"],[[["field30","equal_to","No"]],[["show_fields","field49"]],"and"],[[["field49","equal_to","No"]],[["show_fields","field33"]],"and"],[[["field33","equal_to","No"]],[["show_fields","field34"]],"and"],[[["field34","equal_to","Yes"]],[["show_fields","field35"]],"and"],[[["field36","equal_to","No"]],[["show_fields","field37"]],"and"],[[["field28","equal_to","No"]],[["show_fields","field29"]],"and"],[[["field35","equal_to","No"]],[["show_fields","field36"]],"and"],[[["field25","equal_to","Yes"]],[["show_fields","field26"]],"and"],[[["field36","equal_to","No"]],[["show_fields","field37"]],"and"],[[["field34","equal_to","No"]],[["show_fields","field36"]],"and"],[[["field37","equal_to","No"]],[["show_fields","field43"]],"and"],[[["field16","greater_than","17.9"],["field16","less_than","30.2"]],[["show_fields","field23"]],"and"]]
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 – 30.1 kg/m2 and have a weight above 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 with Coronavirus/COVID-19?
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 had surgery in the last 12 weeks?
9. Are you a smoker or do you use e-cigarettes?
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 if female or 21 units a week if male?
12. Have you had any body piercings or tattoos in the last 6 months?
13. Have you had any history of drug or alcohol abuse in the past 2 years?

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

keyboard_arrow_leftPrevious
Nextkeyboard_arrow_right