We are conducting a clinical trial, in healthy black male and female volunteers of Sub-Saharan African origin, to test two investigational medicines when given together to assess their safety and tolerability for their potential future use in the prevention of malaria in countries where the disease is present.
Clinical trial summary
In this clinical trial we are asking 40 healthy black male and female participants of Sub-Saharan African origin aged 18 to 45 to take two investigational medicines, which are intended to be given in the future, to people to prevent malaria, so we can investigate how safe and tolerable (i.e. do the volunteers suffer from any side effects) the medicines are, and measure for how long the medicines stay in your body (i.e. pharmacokinetics). Both investigational medicines are components of two approved anti-malarial medicines (each in combination with another medicine), but they have never been administered together before.
If you are interested in participating in the trial:-
- You will need to attend a screening appointment so that we can check if you are suitable to take part. At this appointment we will perform a number of tests including taking blood, 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 the heart monitor to the unit.
- If results from your screening appointment show you are suitable for the trial, you will be invited to take part. A small group of ten volunteers will initially be enrolled called the “sentinel group”. The data collected from the sentinel group will be carefully reviewed before a larger group (non-sentinel group) of thirty volunteers are able to start the study.
- The sentinel group of 10 volunteers will receive the medicines first and will stay in the clinical research unit for eight days / seven nights and the non-sentinel group of volunteers will be enrolled and take the medicines and are planned to stay in the clinical research unit for six days / five nights, after approval for a reduced length of stay has been approved by the Sponsor. After your in-house stay with us you will be required to return for further out-patient visits: Sentinel Group – on Days, 8, 15, 22 and a final follow-up visit on approximately Day 30. Non-sentinel Group – on Days 6, 8, 15, 22 and a final follow-up visit on approximately Day 30. For all volunteers this means that the total study, from screening visit(s) to the final follow-up visit will take approximately 52 days.
- In total, if you are included in the clinical trial you will come to the research unit seven times if in the non-sentinel cohort and six times if in the sentinel group.
- During your stay with us you will take the two medicines on Days 1, 2, and 3 in the form of tablets (in total between 6 and 8 tablets that you will swallow). You will not know if you are taking active medicines or dummy medicines. We will also perform tests (like those we did at screening) to check how well you tolerate the medicines, to help us understand how long it takes for your body to get rid of the medicines, and to evaluate how the medicines affect your heart’s electrical system.
Who can take part?
We will check your suitability for the clinical trial using the following criteria:-
- You are a healthy person aged between 18 and 45.
- Both of your biological parents are black and are of Sub-Saharan African origin.
- You weigh 50 kg or more and your body mass index (BMI) is between 18 and 28 kg/m2.
- You must be willing to complete a questionnaire (Beck Depression Inventory) that screens for depressive mood symptoms and suicidal thoughts.
- You must not consume tobacco in any form, or other nicotine-containing products, six months before you first receive the investigational medicines.
- You must not test positive for hepatitis B/C, HIV, alcohol or drugs or show any evidence of drug or alcohol abuse. (Alcohol abuse is defined as a regular weekly intake of more than 14 units).
- You must not consume grapefruit, cranberry, pomegranate, star fruit, pomelos, exotic citrus fruits or Seville oranges (including marmalade and juices made from these fruits) 30 days before you first receive the investigational medicines.
- You must be healthy with no underlying medical conditions that may either interfere with your participation in the clinical trial, and/or put you at any significant risk.
- You must not use any prescription medicines in the 14 days before, or over-the-counter medicines in the seven days before the first day you receive the investigational medicines. Some contraceptive medicines are allowed.
- You must not have donated or lost blood within 90 days before you first receive the investigational medicines.
- You must not have had malaria in the previous two years.
- You must not be pregnant or breastfeeding.
- You must not have had a COVID-19 vaccine four weeks prior to the first dose or plan to receive the vaccine until a minimum of one week after the last visit.
- You must agree to not donate sperm or ova (eggs) from the time of the first study drug administration until three months after you finish taking the investigational medicines.
- Female volunteers of childbearing potential, if heterosexually active, must agree to use highly effective contraception starting from one complete menstrual cycle prior to the first day of dosing and continuing until at least thirteen weeks after the last investigational medicine administration.
- Male volunteers must be willing to use appropriate contraception for the duration of the study and continuing until at least thirteen weeks after the last investigational medicine administration.
A full list of do’s and don’ts will be given to you by a member of our recruitment team if you are interested and want to find out more.
Clinical trial payment
In recognition of the time involved in taking part in the trial, you will receive £1,732 (if you are in the sentinel group) or £1,632 (if you are in the non-sentinel group) 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
21st to 27th February
1st, 8th, 15th and 23rd March
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.