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- Your Body Mass Index (BMI) is between 18 and 30 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 are using sufficient contraception or have been postmenopausal for at least one year or have been surgically 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 € 3.361,- 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. For period 1 you will stay in our research facility for 12 days (11 nights) and for period 2 you will stay for 17 days (16 nights) in our research facility in Groningen, location UMCG.
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-180351
Type of study
Soon a study will start at PRA with an experimental compound that is being developed for the treatment of Autism Spectrum Disorder (ASD). ASD is typically characterized by social deficits, communication difficulties, stereotyped or repetitive behaviours and interests, and in some cases, cognitive delays.
The purpose of this research study is to investigate to what extent the experimental compound is safe and tolerated. It will also be investigated how quickly and to what extent the experimental compound is absorbed and eliminated from the body. In addition, it will also be investigated to what extent the compound is tolerated by volunteers if administered alone or in combination with anther compound.
The experimental compound is not registered as a drug but has been given to humans before. The other compound has already been approved. The study will only take place after it has been approved by an Independent Ethics Committee.
Setup and duration of the study
Before the start of the study you will visit the medical screening centre in Groningen.
The study will consist of 2 periods during which you will stay in the clinical research center in Groningen, location UMCG for Group 1 and location Martini for Group 2. For study period 1 you will stay for 12 days (11 nights) and for study period 2 you will stay for 22 days (21 nights) in our research center.
You will receive the experimental compound once daily in the form of an oral tablet. You will receive the approved compound twice daily as capsules.
Blood samples will be taken regularly during the study.
Risks and medical supervision
The experimental compound blocks activation of the vasopressin receptor in the brain and is in development for treatment of the core deficits in ASD.
The approved compound, which is used to treat fungal infections, is known to interfere with the activity of the liver enzyme CYP3A. This enzyme is involved in the breakdown of the experimental compound in the body and will therefore interfere with the level of the experimental compound in the blood.
All compounds can cause side effects, the extent to which this occurs differs between individuals. In previous studies with the experimental compound in 195 healthy volunteers, the compound was safe and generally well tolerated.
The most common side effects of the approved compound are nausea, vomiting, diarrhoea, abdominal pain and rash.
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 65 years old. You can only take part in the study if you do not smoke. Women must be surgically sterile or post-menopausal or use acceptable methods of contraception (birth control) to participate in this study.
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 some herbal remedies/supplements during the study are 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 can take part in the study, you will be medically screened; this screening will take place within four weeks before the start of the study.
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