We are looking for male and female volunteers aged between 18-65 years (inclusive) with a well-functioning Ileostomy which was formed more than 18 months ago. The study drug has the potential to treat inflammatory bowel disease including Crohn’s disease. You will not receive any benefit from participating in this trial other than a detailed medical examination and a payment of £1,545 for your time and inconvenience. The study will involve one screening visit, one inpatient period of 3 days (2 nights) and a follow up visit. The study drug will be administered as oral capsules.
Participants must meet the following criteria:
- You must be in good health and your Ileostomy should be working well.
- Your Ileostomy must not have been done to treat Crohn’s disease or bowel cancer.
- You should have a body-mass index of between 18 and 32 kg/m2 (you can calculate your BMI in the pre-screening form)
- You must not have taken part in another clinical trial within the last 3 months
- You must not be a current smoker (you must have refrained from smoking for at least 3 months).
There are other reasons why you may or may not qualify for this study. You can find out now if can take part by completing this short pre-screening form.
This will involve a doctor going through your medical history and a physical examination. You will have a number of tests during screening including vital signs (heart rate, blood pressure, respiratory rate and temperature), measurement of your height and weight, blood and urine tests. This appointment determines your eligibility to take part in the trial.
You will be required to attend a single admission of 3 days/2 nights.
You will be administered the study drug as capsules following an overnight fast. Throughout the duration of your visit at set time points you will have a number of assessments including; collections of ileostomy fluid, measurement of your vital signs, 12 lead ECGs and blood tests, urine tests, and a physical examination.
This will take place up to 7 days following your discharge from the unit.
Before every clinical trial, each medicine has undergone extensive laboratory testing, and every trial has to be approved by the MHRA (Medicine and Healthcare products Regulatory Agency) and an Independent Research Ethics Committee, who will evaluate and ensure the wellbeing of the volunteers is safeguarded.
The trials are such a valuable part of the process as they are stringently designed to guarantee the quality, reliability, and safety of new medicines.
In the last seven years, Quintiles Drug Research Unit at Guy’s Hospital has conducted over 1000 Phase 1 development studies worldwide. This has seen thousands of paid volunteers taking part in the trials, each making a hugely valuable contribution to medical research.
Quintiles Drug Research Unit at Guy’s Hospital is based in London and has over twenty years of Phase 1 clinical research experience in this unit, and this site alone has been involved in the testing of more than 200 potential new medicines.
If you would like to register to take part in a clinical trial at Quintiles Drug Research Unit at Guy’s Hospital you can do so via our secure online form.
By registering you are not making a commitment but simply expressing an interest to find out more. We will ask you a few more details about your health and will then discuss what studies you may be suitable for.
Studies will be approved by a recognized independent Research Ethics Committee.