PRA-178341 Alzheimer and ALS tot € 2.782,-

Many places available

Description

Study of an investigational compound that is being developed for the treatment of Alzheimer disease and ALS

Requested participants

  • M/F, healthy, 18 - 55 years old
  • Non-smokers only

Duration and visits

  • 19 days stay
  • 1 short visits

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Research details

Particulars

  • You do not smoke. 
  • Females are only allowed to participate in this study if you:  
  • -> Are sterilized for at least 6 months (Essure® methods is not allowed for this study)
    -> Or if you are postmenopausal for at least 12 months (without menstrual periods)
  • Your Body Mass Index (BMI) is between 19 and 32 kg/m2 and your body weight is at least 50 kg. The BMI shows the relation between body weight in kilograms and height in meters.
  • For the groups B1a untill B3c 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. 
  • To determine if you are suitable to participate in this study, you will undergo a medical screening visit.
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Compensation

You will receive a gross compensation of €1.510,- for complete participation in both periods of Group A4 and A4a. If it will be decided to cancel the second period, you will receive a gross compensation of €1.159,-, In this last compensation we took the time that you kept free for period 2 into account.

You will receive a gross compensation of €2.782,- for complete participation in one of the groups B1a-B3c.

You will receive a gross compensation of €2.282,- for complete participation in group B4.

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 Group A2 , A4  and A4a the study, consists of 2 periods in which you will stay in our research facility in Groningen (location Martini) for 5 days (4 nights) for each period.

One week after the first period of Group A4 or  group A4a, it will be decided if the second period is necessary or if this period will be cancelled. Please note that you have to be available for both periods.

For Part B, the study, consists of 1 period in which you will stay in our research facility in Groningen (location Martini) for 19 days (18 nights), followed by two short visits.

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-178341

Type of study

Soon, a research study will start at PRA of a new compound that may eventually be used for the treatment of Alzheimer’s disease and amytotrophic lateral sclerosis, ALS. ALS is a disease of the nerve cells that control the muscles.

This study will be performed in approximately 62 healthy male and female volunteers. The study will be performed in 2 parts: Part A and Part B.

The purpose of this study is to investigate how safe the new compound is when it is administered to healthy subjects. The compound has not been administered to humans before. It has been previously tested in the laboratory and on animals. The compound will be studies at different dose strengths. A compound with similar activity is currently being tested in humans in the USA.

It will also be investigated how quickly and to what extent the compound is absorbed and eliminated from the body (this is called pharmacokinetics) and the effect of food on the absorption and elimination of the compound (only for Part A, Group 2 and possibly Group 4). In addition, the effect of the compound on a specific protein will be investigated (this is called pharmacodynamics).

The effects of the 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 - Part A

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 are eligible for participation, for Group A1 and A3, the study consists of 1 period in which you will stay in our research facility in Groningen (location Martini) for 5 days (4 nights), followed by one short visit. For Group A2 and possibly A4 and A4a, the study consists of 2 periods in which you will stay in our research facility in Groningen (location Martini) for 5 days (4 nights) for each period, followed by one short visit. One week after the first period of Group A4, it will be decided if the second period is necessary or if this period will be cancelled. Please note that you have to be available for both periods.

Group A1 and A3 will receive the new compound or placebo once as oral capsules. Group A2 and A4 will receive the new compound once at each period. If Group A4 only has 1 period, you will receive the new compound or placebo only once.

Blood samples and urine will be taken regularly during the study. Also your heart rhythm will be monitored continuously from 26 hours before administration of the study compound until 24 hours thereafter. At some moments during these periods you will be asked to lie down quietly for 15 minutes. As long as you are connected to the telemetry and holter you cannot take a shower, you have to behave as relaxed as possible and have to prevent that you will sweat. As soon as you are connected, you cannot use electric devices (razor device, electric toothbrush, hairdryer) anymore and you may not wear jewelry.

Setup and duration of the study - Part B

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 are eligible for participation, the study consist of 1 period during which you will stay in the research center in Groningen (location Martini) for 19 days (18 nights), followed by two short visits.

 

During this period, for Group B1, B2 and B3, the new compound or placebo will be given as oral capsules twice daily on Day 1 until Day 13. I addition you will receive the new compound or placebo on Day 14 once.

Group B4 will receive the new compound or placebo as oral capsules once daily on Day 1 until Day 14.

Blood samples and urine will be taken regularly during the study. Also your heart rhythm will be monitored continuously from 26 hours before the first administration of the study compound on Day 1 until 8 hours after dosing on Day 2 and from 1 before the administration on Day 14 until 24 hours thereafter. At some moments during these periods you will be asked to lie down quietly for 15 minutes.

As long as you are connected to the telemetry and holter you cannot take a shower, you have to behave as relaxed as possible and have to prevent that you will sweat. As soon as you are connected, you cannot use electric devices (razor device, electric toothbrush, hairdryer) anymore and you may not wear jewelry.

In addition cerebrospinal fluid will be collected via a lumbar puncture on Day -1 and Day 12 for Group B1, B2 and B3. 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 drained (maximum of 20 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.

To limit the chance of headaches it is important that you drink enough liquids (minimal 1.5 liters a day, from 1 day prior to the puncture [Day -2/Day 11] until 1 day thereafter [Day 1/Day 13]).

During the lumbar puncture and the 1.5 to 2 hours thereafter fluid will be administered using an intravenous infusion.

Risks and medical supervision - Part A

The study compound may cause side effects. As the compound will be administered to humans for the first time in this study, side effects in humans are not known yet. In studies with other compounds with a similar mode of action only mild side effects were observed. The most common side effects were headache and contact dermatitis.

The compound has been studied the laboratory and in rats and monkeys. The most frequently observed side effects in animals, observed at very high doses, much higher than the equivalent doses to be studied in humans, were: swollen lymph nodes and spleen, increased activity of the bone marrow and increased amounts of specific types of white blood cells in the blood, reduction in red blood cells (anemia), and skin reactions (also inside the mouth). These effects were observed after multiple administrations of the compound and disappeared after discontinuation of the compound. In some monkey, skin reactions (also inside the mouth) were seen after multiple administrations of the compound at doses much higher than planned for this study.

During this study possible changes in the amounts of white and red blood cells and changes of the skin will be closely monitored. Skin reactions may have to be evaluated by a dermatologist in Martini Hospital and may require taking a skin biopsy.

To keep the risks as low as possible, your health will be monitored continuously during the study.

You should be aware that  the adverse events mentioned above and possibly other, still unknown adverse events, may occur during the study.

Risks and medical supervision - Part B

The study compound may cause side effects. As the compound will be administered to humans for the first time in this study, side effects in humans are not known yet. In studies with other compounds with a similar mode of action only mild side effects were observed. The most common side effects were headache and contact dermatitis.

The compound has been studied the laboratory and in rats and monkeys. The most frequently observed side effects in animals, observed at very high doses, much higher than the equivalent doses to be studied in humans, were: swollen lymph nodes and spleen, increased activity of the bone marrow and increased amounts of specific types of white blood cells in the blood, reduction in red blood cells (anemia), and skin reactions (also inside the mouth). These effects were observed after multiple administrations of the compound and disappeared after discontinuation of the compound. In some monkey, skin reactions (also inside the mouth) were seen after multiple adminstrations of the compound at doses much higer than planned for this study.

During this study possible changes in the amounts of white and red blood cells and changes of the skin will be closely monitored.

The collection of cerebrospinal fluid can also cause some side effects. 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.

You should be aware that the adverse events mentioned above and possibly other, still unknown adverse events, may occur 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. Your Body Mass Index (BMI) is between 19 and 30 kg/m2 and your body weight is at least 50 kg. 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) 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. 

More info Less info

Group B3b

€ 2.782,-

19 days stay

  • 21 Aug 2018 up to and including 8 Sep 2018

short stay

Inapplicable

short visit

  • 11 Sep 2018

Group B3c

€ 2.782,-

19 days stay

  • 28 Aug 2018 up to and including 15 Sep 2018

short stay

Inapplicable

short visit

  • 18 Sep 2018

Group B4

€ 2.282,-

19 days stay

  • 17 Sep 2018 up to and including 5 Oct 2018

short stay

Inapplicable

short visit

  • 8 Oct 2018

Group B3a

€ 2.782,-

19 days stay

  • 14 Aug 2018 up to and including 1 Sep 2018

short stay

Inapplicable

short visit

  • 4 Sep 2018
Group full

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