Learn more about this research?
- You are a non-smoker
- Your body weight must be at least 50 kg and your Body Mass Index (BMI) is between 18 and 32 kg/m2. The BMI shows the relation between body weight in kilograms and length in meters.
- For females: you are only to participate in this study if you are using highly effective methods of contraception (i.e. a condom combined with hormonal contraceptives such as the pill, or an intrauterine device) or if you have been postmenopausal for at least one year of if you have been surgically sterilized.
- You are willing to consume ethanol, sesame oil and milk and you are not intolerant to these products.
- To determine if you are suitable to participate in this study, you will undergo a medical screening.
You will receive a gross compensation of €2.212,- for participation in one of the groups of this study.
Travelling expenses will be reimbursed based on the distance traveled (€0,19 net per kilometer) with a minimum of €12,- and a maximum of €160,- (840 kilometers) per return, regardless of the mode of transportation.
Period of stay and research
The study consists of 3 periods during which you will stay in our research facility in Groningen (Martini site) for 6 days (5 nights) per period.
Please note: You have to be available for all dates for the group of choice to be able to participate in this study. These are the currently planned dates; however, these may be subject to change.
Information sheet PRA-179761
Type of study
The purpose of the study is to investigate what the effect is of different meal compositions, milk and alcohol on how quickly and to what extent the study drug is absorbed, distributed, metabolized and eliminated from the body. It will also be investigated how safe the study drug is and how well it is tolerated when it is administered to healthy volunteers without food and with different meal types, milk or alcohol.
The study drug is not yet approved for general use but has been given to humans before in research studies conducted to obtain its approval. The study will only take place after it has been approved by the Independent Ethics Committee.
Setup and duration of the study
The actual study will consist of 3 periods during which you will stay in the clinical research facility (Martini site) for 6 days (5 nights) per period.
You will receive the study drug once per period in the form of an oral solution. Each volunteer will receive 3 of the 5 treatments. All volunteers receive the study drug once under fasted conditions (Treatment 1; without food) in 1 of the periods. In the other periods, volunteers will receive 2 out of the 4 remaining treatments. The other treatments are administration of the study drug once after a high-fat and high-calorie breakfast (Treatment 2), administration after a low-fat and low-calorie breakfast (Treatment 3), administration before intake of 500 milliliters whole milk (Treatment 4) and administration before intake of 40 grams alcohol in 500 milliliters of lemonade (Treatment 5). To which 2 treatments besides Treatment 1 you are assigned will be determined by chance, and the order in which you will receive the treatments over the 3 periods will also be determined by chance.
Blood samples will be taken regularly during the study. In addition, several questionnaires to assess volunteers for potential suicide-related thoughts and to assess the complex attention, information processing speed and psychomotor functioning will be completed at certain timepoints during the study.
Risks and medical supervision
The study drug is extracted from cannabis plants under highly controlled conditions to ensure the product is always the same. In previous studies with the study drug from this Sponsor, it has not been associated with the potential euphoric effects that have been documented with recreational cannabis use.
All drugs can cause side effects; the extent to which this occurs differs between individuals. The following side effects have been reported by children and adults with severe epilepsy who have taken the study drug so far: feeling sleepy, not feeling like eating as much, diarrhea and fever.
You will be under strict medical supervision during the study. Before the study and at the end of the study you will undergo an extensive medical screening.
Conditions for participation
You are a healthy male or female between 18 and 60 years old. You can only take part in the study if you do not smoke. Females are only allowed to participate in this study if you are using highly effective contraception (i.e. a condom in addition to, hormonal contraceptives such as the pill, or an intrauterine device) or if you have been postmenopausal for at least one year or if you have been surgically sterilized.
The study will be executed under standardized conditions. Use of your own medication, alcohol, regular coffee and tea, cola, power drinks, chocolate (including products made of chocolate), grapefruit (juice) and tobacco products during the study is not allowed. Also before the study there will be restrictions for these products. Use of decaffeinated coffee and (herbal) teas without caffeine is allowed. Before you are allowed to take part in the study, you will be medically screened; this screening will take place within 4 weeks before the start of the study.
- Period of stay
- 3× 6 days
- 0 times
- € 2.212,-
Group 4€ 2.212,-
3× 6 days stay
- 27 Sep 2018 up to and including 2 Oct 2018
- 11 Oct 2018 up to and including 16 Oct 2018
- 25 Oct 2018 up to and including 30 Oct 2018
Group 2€ 2.212,-
3× 6 days stay
- 12 Sep 2018 up to and including 17 Sep 2018
- 26 Sep 2018 up to and including 1 Oct 2018
- 10 Oct 2018 up to and including 15 Oct 2018
Group 3€ 2.212,-
3× 6 days stay
- 20 Sep 2018 up to and including 25 Sep 2018
- 4 Oct 2018 up to and including 9 Oct 2018
- 18 Oct 2018 up to and including 23 Oct 2018