PRA-177021

Parkinson’s disease (part D)

Study of an investigational compound that is being developed for the treatment of Parkinson’s disease

Particulars

  • You must speak and understand English or Dutch to participate.
  • You are a healthy male or female
  • You do not smoke.
  • Your Body Mass Index (BMI) is between 18.5 and 32 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).
  • To determine if you are suitable to participate in this study, you will undergo a medical screening visit.
  • 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 are only allowed to participate, if you did not participate in a drug study within the 60 days prior to the screening for this study.
Calculate BMI

Compensation

You will receive a gross compensation of € 4172,- for participation in group D1a or D1b. In case that the pulmonary test will be on a different day than the follow-up visit, you will receive an additional gross compensation of € 75.-.

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 D, the study, consists of 1 period in which you will stay in our research facility in Groningen for 31 days (30 nights), followed by one short visit. Finally, there will be a follow-up visit including a pulmonary function test. Please note: it may happen that the pulmonary function test takes place on a day other than the follow-up visit.

Please note: You must 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.

More info

Type of study

Soon, a research study will start at PRA of a new compound that may eventually be used for the treatment of Parkinson’s disease.

This study will be performed in approximately 152 healthy male/female volunteers. The study will be performed in 4 parts, Part A, Part B, Part C, and Part D. The remainder of this document concerns Part D only. Part D of the study will consist of 2 groups of 8 volunteers each. You can participate in one of these groups.

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 function 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 centre in Groningen location Martini Hospital for 31 days (30 nights), followed by one short visit. Finally, there will be a follow-up visit including a pulmonary test. Please note: it may happen that the pulmonary function test takes place on a day other than the follow-up visit. During this period the new compound or placebo will be given as oral capsules once daily on 28 consecutive days. Blood samples and urine will be taken regularly during the study

Risks and medical supervision

The new compound may cause side effects. As compound was administered to man for the first time in this study, side effects are limited to those reported in this study. To date 78 persons received single or multiple doses of the study compound during this study. Headache and nausea are the most frequently observed complaints, but no side effects could be linked to the study compound.

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.

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

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. You have not participated in an earlier part of this study. 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.

Between 3-9 days after the (last) leave from the research centre your health will be checked for the last time during a short visit.

Sign up for one of the following study groups

Group D1a

31 days stay

  • 21 Aug 2019 up to and including 20 Sep 2019

short visit

  • 26 Sep 2019
€ 4.172,- Select

Group D1b

31 days stay

  • 28 Aug 2019 up to and including 27 Sep 2019

short visit

  • 3 Oct 2019
€ 4.172,- Select