Clinical trial summary
In this clinical trial, we are asking up to 8 Caucasian healthy male and female participants aged 20 to 40 to take part in a trial for an investigational medicine, so we can see whether the investigational drug interacts with any other medication. You will be paid for your time if you take part in this clinical trial.
If you are interested in participating in the trial:
- This clinical trial part will involve you staying with us once for 9 days / 8 nights at our private clinical research unit in London Bridge.
- You will need to attend a screening appointment so we can check if you are suitable to take part in the trial. At this appointment we perform a number of tests including, taking blood samples, checking your heart and carrying out a physical examination to see if you will be OK to take part in the clinical trial. You will be required to wear a heart monitor for 24 hours after the screening appointment. You will need to return this to the unit.
- If results from your screening appointment show you are suitable for the trial, you will be invited to take part.
- This will involve a stay of 9 days / 8 nights in our clinical research unit.
- After your stay with us you will be required to return for further appointment on Day 15 of the trial.
- In total, if you are included in the clinical trial you will come to the research unit 3 times.
During your stay with us you will receive a single dose of medication used for sedation and multiple doses of the investigational medicine via your mouth. We will conduct a number of assessments (like those we did at screening) to check how much the investigational drug interacts with another medication and how well you tolerate the investigational medicine.
Who can take part?
We will check your suitability for the clinical trial using the following criteria:
- You are a healthy Caucasian male or female aged 20 to 40 years of age.
- Your Body Mass Index is between 18.0-25.0 kg/m2.
- You must be healthy with no underlying medical conditions that may affect the trial or put you at any significant risk.
- You must be able to consume all meals as part of a standardised diet, including meat, dairy, and gluten.
- Female participants of childbearing potential, if heterosexually active, must agree to the use of highly effective contraception starting from one complete menstrual cycle prior to the first dose until at least 5 weeks after the last dose.
- Female participants must not use combined hormonal contraception or hormonal replacement therapy containing oestradiol or ethinyloestradiol.
- Male participants must be willing to use appropriate barrier contraception starting from the first dose for at least 13 weeks after last dose, with female partners of child-bearing potential, including partners that are already pregnant.
- You must not donate sperm or ova (eggs) from the time of the first study drug administration until three months after the last follow-up visit.
- You must not test positive for alcohol or drugs at screening or admission, or show any evidence of alcohol or drug abuse within the last two years.
- You must not have used tobacco (e.g., smoking, patch, electronic cigarettes) within three months of the first dose of the study drug.
- You must not have taken part in another clinical trial in the last three months.
- You must not use any prescription drugs within 14 days or over-the-counter drugs within 7 days of the first dose of the study drug.
- You must not have a history of severe allergic reactions to any product.
Clinical trial payment
In recognition of the time involved in taking part in the trial, you will receive £2,948 (£1,966 clinical trial payment and £982 bonus) on completion of the clinical trial, provided you comply fully with all the clinical trial requirements. This amount is based on the anticipated clinical trial plan and will be adjusted pro-rata (i.e. same amount of money paid per unit of time), should we invite you to attend extra visits.
Clinical trial dates
Participants will only be selected to participate in one of the cohorts below.
Admission: 11th to 19th July
Follow-up visit: 26th July
Admission: 12th to 20th July
Follow-up visit: 27th July
You may be required to remain resident in the unit until the resolution of any safety issues, after which you will be discharged from the unit.
The contents of this page have been approved by an ethics committee. Any response to this advertisement will be recorded. Your response will not place you under any obligation to participate in this trial.