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- You do not smoke.
- Your Body Mass Index (BMI) is between 18.5 and 30 kg/m2 and your body weight is at least 50kg. The BMI shows the relation between body weight in kilograms and height in meters.
- Females are only allowed to participate in this study if they:
-> are sterilized for at least 6 months (Essure® methods is not allowed for this study)
-> are postmenopausal for at least 12 months (without menstrual periods).
- For groups B3a to B4c: You are willing to undergo 2 lumbar punctures. During these punctures cerebrospinal fluid will be collected via a lumbar puncture. A fine needle will be inserted at the space between two vertebrae in the lower back.
- You are willing to perform a pulmonary function test as part of the screening, if you are still eligible after the first screening visit. The pulmonary function test will be performed in a second screening visit, so the screening for this study contains 2 screening visits.
- To determine if you are suitable to participate in this study, you will undergo a medical screening visit.
You will receive a gross compensation of € 2.517,- for participation in one of the groups B3a to B4c.
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
For Part B, the study, consists of 1 period in which you will stay in our research facility in Groningen (location Martini) for 15 days (14 nights), followed by one short visit.
Information sheet PRA-177021
Type of study
This study will be performed in 72 healthy male and female, young and elderly volunteers. The study will be performed in 3 parts, Part A, Part B, and Part C. Part A will be performed in approximately 32 young volunteers, Part B will be performed in approximately 30 young volunteers and Part C will be performed in approximately 10 elderly volunteers. The remainder of this document concerns Part B only.
The purpose of this study is to investigate how safe the new compound is when it is administered to healthy subjects. The new compound has not been administered to humans before. It has been previously tested in the laboratory and on animals. The new compound will be studied at different strengths. A compound with a similar activity has been tested in humans before.
It will also be investigated how quickly and to what extent the new compound is absorbed and eliminated from the body (this is called pharmacokinetics). In addition, the effect of the new compound on a specific protein will be investigated (this is called pharmacodynamics).
The effects of the new compound will be compared to the effects of a placebo. A placebo is a medicine without any active ingredient. It is a ‘fake’ medicine.
The study will only take place after it has been approved by the Independent Ethics Committee
Setup and duration of the study
To determine if you are suitable to participate in this study, you will undergo a medical screening visit at the centre in Groningen (location Martini). If you pass the first screening you will have to return for a pulmonary test, which is also part of the screening.
Following the two screening visits, if you are eligible for participation, the study consist of 1 period during which you will stay in the research center in Groningen location Martini Hospital for 15 days (14 nights), followed by one short visit. During this period the new compound or placebo will be given as oral capsules once daily on 10 consecutive days.
Blood samples and urine will be taken regularly during the study. In addition cerebrospinal fluid will be collected via a lumbar puncture twice. A fine needle will be inserted at the space between two vertebrae in the lower back. The puncture will be performed in a sitting and stooped position, under local anesthesia and will be performed by a specialist (anesthesiologist). When enough cerebrospinal fluid has been collected (maximum of 6 milliliter), the needle will be removed. After the procedure you will be transferred in a wheelchair to your bed. After that you have to lie down on your back for another 1.5 - 2 hours, this is to decrease the risk on leakage of cerebrospinal fluid.
During the lumbar puncture and the 1.5 to 2 hours thereafter fluid will be administered using an intravenous infusion.
Risks and medical supervision
The new compound may cause side effects. As compound will be administered to man for the first time in this study, side effects of the compound in man have not been reported to date. However, the compound has been studied the laboratory and in rats and monkeys. The most frequently observed side effects in animals were: decrease in blood pressure and heart rate.
You should be aware that the adverse events mentioned above and possibly other, still unknown adverse events, may occur during the study.
In Group B2, B3 and B4 cerebrospinal fluid will be collected on 2 occasions. Insertion of the needle for the collection of cerebrospinal fluid may be painful. Removing the needle is painless. Usually no complications occur during a lumbar puncture. Sometimes, during the puncture, a nerve can be hit. Then you will feel an electric pulse or a shooting pain in your leg. This can be painful, but is not harmful. This method has been performed with humans before and was generally well tolerated. A number of complaints and complications related to the procedure are already known from previous studies. The most common side effects are headache (post-lumbar puncture headache), back pain and neck pain, discomfort during the procedure, pain at the location of the spinal catheter, dizziness and fainting.
The risks of above mentioned complaints are limited, but you may suffer from these or other, still unknown, complications. To keep the risks as low as possible, your health will be monitored continuously during the study.
Conditions for participation
You are a healthy male or female between 18 and 50 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 they are sterilized for at least 6 months (Essure® methods is not allowed for this study) or when they are postmenopausal for at least 12 months (without menstrual periods).
The study will be done 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 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 are allowed to take part in the study, you will be medically screened.
- Period of stay
- 15 days
- 1 times
- € 2.517,-
Group B3c back-up€ 2.517,-
15 days stay
- 4 Jun 2018 up to and including 18 Jun 2018
- 25 Jun 2018
Group B4a€ 2.517,-
15 days stay
- 18 Jun 2018 up to and including 2 Jul 2018
- 9 Jul 2018
Group B4b€ 2.517,-
15 days stay
- 25 Jun 2018 up to and including 9 Jul 2018
- 16 Jul 2018
Group B4c€ 2.517,-
15 days stay
- 2 Jul 2018 up to and including 16 Jul 2018
- 23 Jul 2018