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- You do not smoke.
- Your body weight must be at least 50 kg and your Body Mass Index (BMI) must be between 18.0 and 32.0 kg/m2. The BMI shows the relation between body weight in kilograms and height in meters.
- Women are only allowed to participate in this study if they have been postmenopausal for at least 1 year or if they have been sterilized.
- To determine if you are suitable to participate in this study, you will undergo a medical screening.
You will receive a gross compensation of €1870,- 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 2 periods of residency in the clinic. During period 1 you will stay in our research facility in Groningen (Martini site) for 7 days (6 nights), followed by 2 short visits. During period 2 you will stay in our research facility for 6 days (5 nights), followed by 3 short visits. Between periods 1 and 2 you will take the study medication daily at home.
Information sheet PRA-179751
Type of study
The purpose of the study is to investigate the effect of multiple doses of 2 commonly used drugs (itraconazole or fluconazole) on how quickly and to what extent the study drug is absorbed and eliminated from the body. The safety of the study drug and how well it is tolerated when it is administered to healthy volunteers with and without itraconazole or fluconazole will also be investigated.
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 study will consist of 2 periods of residency in the clinic. During period 1 you will stay in our research facility in Groningen (Martini site) for 7 days (6 nights), followed by 2 further short non-residential visits. During period 2 you will stay in our research facility for 6 days (5 nights), followed by 3 further short non-residential visits over the next 3 days.
In each period you will receive 1 dose of CBD (2 doses in total during your participation in the study) as an oral solution. Between period 1 and period 2 you will take either itraconazole or fluconazole as oral capsules daily at home.
Risks and medical supervision
CBD is a new study drug that may be used for the treatment of neurological conditions. It is extracted from cannabis plants under highly controlled conditions to ensure the product is always the same. In previous studies with CBD from this Sponsor, CBD has not been associated with the potential euphoric effects that have been documented with recreational cannabis use.
Itraconazole and fluconazole are approved medicines for the treatment of fungal and yeast infections. Itraconazole has been on the market since 1992, fluconazole since 1988.
You will be under strict medical supervision during the study. Before the study and at the end of the study you will undergo extensive medical screening. All potential drugs can cause side effects; the extent to which this occurs differs in each person.
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. Women must be postmenopausal for at least one year or have been surgically sterilized. The study will be conducted under standardized conditions. Use of your own medication, alcohol, regular (caffeine-containing) coffee and tea, cola, power drinks, chocolate (including products made of chocolate) and grapefruit (juice) products during the study is not allowed. There will also be restrictions on the use/consumption of these products before the study. Use of decaffeinated coffee and (herbal) teas without caffeine is allowed. Before you can 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
- 13 days
- 5 times
- € 1.870,-
Groep 1€ 1.870,-
13 days stay
- 18 Jul 2018 up to and including 24 Jul 2018
- 1 Aug 2018 up to and including 6 Aug 2018
- 25 Jul 2018
- 26 Jul 2018
- 7 Aug 2018
- 8 Aug 2018
- 9 Aug 2018
Groep 2€ 1.870,-
13 days stay
- 25 Jul 2018 up to and including 31 Jul 2018
- 8 Aug 2018 up to and including 13 Aug 2018
- 1 Aug 2018
- 2 Aug 2018
- 14 Aug 2018
- 15 Aug 2018
- 16 Aug 2018
Groep 3€ 1.870,-
13 days stay
- 15 Aug 2018 up to and including 21 Aug 2018
- 29 Aug 2018 up to and including 3 Sep 2018
- 22 Aug 2018
- 23 Aug 2018
- 4 Sep 2018
- 5 Sep 2018
- 6 Sep 2018
Groep 4€ 1.870,-
13 days stay
- 22 Aug 2018 up to and including 28 Aug 2018
- 5 Sep 2018 up to and including 10 Sep 2018
- 29 Aug 2018
- 30 Aug 2018
- 11 Sep 2018
- 12 Sep 2018
- 13 Sep 2018