The aim of the study is to assess the quality and duration of your sleep, and to assess your level of alertness and ability to perform certain tasks in the morning after you wake up following an evening dose of either study drug, at two different doses, or placebo (dummy drug). Each group of participants will receive all 3 treatments in turn but in a different order.
We are currently looking for healthy males, aged 18-55. To be eligible you must be in good health and must not have any current or history of sleep problems. You should usually go to bed between 10pm and midnight (12am), spend 7-8.5 hours in bed and have normal sleep habits (e.g. no shift work or daytime naps). You must also be a non-smoker for at least 3 months and should not be taking any regular medications. You must also have a body mass Index (BMI) of between 18 and 30 kg/m2 and a body weight of at least 50 kg, which we will check for you. You must be using male condoms, and any females partners must also be on an effective form of contraception (prescribed hormonal implants, contraceptive patches, contraceptive injections, oral contraceptives, and intrauterine device (IUD)) during the trial and for 3 months after the final discharge from the clinic.
To be eligible to take part you must be:
• A Healthy Male aged 18-55 Years with a BMI of 18-30 kg/m2 and a weight of at least 50 kg.
• Taking no medication.
• A Non-smoker/not using nicotine replacement products for at least 3 months
• Not have a history of any significant sleep problems.
• Have a regular sleep/wake schedule, going to bed between 10pm and 12am and sleeping between 7-8.5 hours.
• Available for the duration of the study (approximately 2 months).
• Be registered with a GP.
• Be willing to use double barrier method for contraception.
• Not have taken part in another clinical trial or donated blood for 3 months prior to your screening appointment.
The study comprises of 6 visits to Surrey CRC. You must be available for the whole duration of the study (approximately 2 months from screening). During the first visit you will be seen by one of the Research Centre’s doctors; a full explanation of the study will be given, you will go through the consent process and you will be asked to give details of your medical history during the medical screening. Routine blood tests and urine samples will be taken to test for HIV, Hepatitis B & C, drugs of abuse and nicotine use. In addition, an alcohol breath test will be performed. Your vital signs (heart rate, breathing rate, blood pressure and oral temperature), and ECG (a recording of the electrical activity of your heart), your height and weight will be measured and the study doctor will perform a routine physical examination to evaluate your health. You will be required to complete questionnaires about your health and sleep patterns. If you decide to take part in the study your GP will be contacted, with your permission, in order to notify him/her of your participation. This visit will last up to 4 hours.
At your screening appointment you will receive an actiwatch, which is a wristwatch device that records your sleep wake patterns. You will be required to wear this watch for the duration of the study.
If you pass that you will be invited in for a 1 night sleep assessment before being accepted onto the study. This will allow you to get used to the study sleep labs and we will also check for presence of any sleep disorders, which might exclude you from the study. Your sleep will be monitored and recorded during the night using electrodes attached to your body and scalp (using a water soluble paste); this is called polysomnography (PSG). The PSG will record brain and muscle activities, eye movement, heart activity, airflow and any changes in your sleep or wakefulness.
If you are still eligible, you will then go on to complete 3 treatment periods (Visits 3-5) which each consist of a two night residential stay. There will be a gap (washout period) of 7 days between each dose so that the study drug has cleared from your system before you start the next treatment. The first night will be an adaptation night and you will receive the study drug on the second night. You will not know which medication you will be taking on each visit. During your residential stays you will be required to wear the electrodes as your sleep will be recorded. Your 6th and final visit will be a follow-up visit; it will be scheduled between 7 and 14 days after the last treatment night. You will be carefully monitored throughout the study period by our experienced clinical staff and doctors.
You will be reimbursed for your time in the region of £1400, plus reasonable travel expenses will be provided for your visits.
If you have already registered with us or have previously taken part in a study at the CRC please click "already registered" to express your interest. If you have not previously registered please click "new participant application form".