PRA-19481X

MS

Study of a new compound that could be used for the treatment of MS (Multiple Sclerosis)

Besonderheiten (auf Englisch)

  • We are looking for healthy males and females between 18 and 65 years old.
  • Your body weight is between 50 kg and 92 kg and your Body Mass Index (BMI) is between 18.5 and 30.0 kg/m2.
  • Both smokers and non-smokers can participate, although smoking or use of other nicotine containing products(e.g. nicotine gum) is not allowed during your stay in the clinic.
  • As a male you are only allowed to participate in this study if:
    • your fertile female partner uses an intrauterine device or hormonal contraceptive (e.g. the pill) and you use 1 of the following forms of contraception: a condom, diaphragm or cervical cap;
    • or your female partner is postmenopausal (without menstrual periods);
    • or you are totally abstinent (not sexually active) as a result of your lifestyle.
  • As a female you are only allowed to participate in this study if:
    • you use an intrauterine device or hormonal contraceptives (e.g. the pill) combined with 1 of the following forms of contraception: a condom, diaphragm or cervical cap or you are using this from screening;
    • or you have been postmenopausal for at least 12 months (without menstrual periods);
    • or if you have been surgically sterilized for at least 6 months before the start of the study;
    • or you are totally abstinent (not sexually active) as a result of your lifestyle.
  • You have not participated in any other drug study within 30 days preceding the first administration of the study compound.
  • To determine if you are suitable to participate in this study, you will undergo a medical screening. The medical screening for this study will consist of two visits. During the first screening visit we will take a blood- and urine sample to evaluate the presence of the John Cunningham Virus (JCV). If it turns out that you are not a carrier of this virus, the remainder of the medical screening will be conducted during the second visit.
BMI berechnen

Vergütung (auf Englisch)

You will receive a gross compensation of € 4133,- for full participation in one of the groups. 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, irrespective of the method of transport.

Periode und Studie (auf Englisch)

For each group the study consists of 1 period where you will stay for 4 days (3 nights) in our research center in Groningen. After this period there will be 12 short visits to our research center.

Please note: You have to be available for all dates of the group of your choice to be able to participate in this study.

Sonstige Information (auf Englisch)

Type of study

Soon a new research study will start at PRA to compare a new compound that could be used for the treatment of MS (Multiple Sclerosis)

 

The study is intended to develop a study compound which is similar to a registered compound. The registered compound is a drug approved in Europe and the USA for the treatment of Multiple Sclerosis (MS) and in the USA also for the treatment of Crohn’s Disease. The purpose of the study is to investigate how quickly and to what extent the study compound will be absorbed and eliminated by the body (this is called pharmacokinetics) in comparison with the registered compound. It will also be investigated how the body responds to the study compound (this is called pharmacodynamics) compared to the two registered products. In addition, the study will assess the safety and tolerability profiles of study compound and both registered products.

This study does not aim to improve your health, but is necessary for the further development of this compound. The study will only take place after it has been approved by the Independent Ethics Committee.

Setup and duration of the study

For each group the study consists of 1 period where you will stay for 4 days (3 nights) in our research center in Groningen. After this period there will be 12 short visits to our research center. Prior to the study you will visit the medical screening center in Groningen on two occasions. During the first screening visit we will take blood samples to evaluate the presence of antibodies against the registered drug and John Cunningham Virus (JCV). During the second screening visit, the remaining part of the medical screening (consisting of, amongst others, a physical examination, measurement of your weight, height, blood pressure, heart rate and body temperature and making a heart tracing) will be conducted. You will receive one of the three study compounds once via an intravenous infusion of 60 minutes. Whether you will receive the study compound, EU­approved compound, or US-licensed compound will be determined by chance.

You can find the exact dates of each group on our website. If the dates do change you will be notified as soon as possible. Upon admission to the clinic you must have fasted for at least 4 hours. Blood samples will be taken regularly during the study.

Risks and medical supervision

As with any medicine, the registered drug may cause side effects, although not everybody gets them. The most common reported (in up to 1 in 10 people) side effects of the registred compound are: urinary tract infection, sore throat and runny or congested nose, shivering, itchy rash (hives), headache, dizziness, feeling sick (nausea), being sick (vomiting), joint pain, fever, tiredness. You should be aware that still unknown side effects may occur during the study.You will be under strict medical supervision during 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. You can only take part in the study if you do not smoke or if you are a light smoker. The study will be executed under standardized conditions. Use of your own medication, alcohol, regular coffee and tea, cola, power drinks and chocolate (milk) during the study is not allowed. Also before the study there will be restrictions for these products. Use of decaffeinated coffee and (herbal) teas without caffeine (also called theine) is allowed. Before you are allowed to take part in the study, you will be medically screened; this screening will take place within 8 weeks before the start of the study.

Registrieren Sie sich unverbindlich für eine der unten aufgeführten Studiengruppen

Group 20

4 Tage Aufenthalt

  • 24 Feb 2020 bis einschl. 27 Feb 2020

kurzer Besuch

  • 29 Feb 2020
  • 3 Mär 2020
  • 10 Mär 2020
  • 17 Mär 2020
  • 24 Mär 2020
  • 31 Mär 2020
  • 7 Apr 2020
  • 21 Apr 2020
  • 5 Mai 2020
  • 12 Mai 2020
  • 19 Mai 2020

Nachuntersuchung

  • 25 Aug 2020
€ 4.133,- Wählen

Group 21

4 Tage Aufenthalt

  • 27 Feb 2020 bis einschl. 1 Mär 2020

kurzer Besuch

  • 3 Mär 2020
  • 6 Mär 2020
  • 13 Mär 2020
  • 20 Mär 2020
  • 27 Mär 2020
  • 3 Apr 2020
  • 10 Apr 2020
  • 24 Apr 2020
  • 8 Mai 2020
  • 15 Mai 2020
  • 22 Mai 2020

Nachuntersuchung

  • 28 Aug 2020
€ 4.133,- Wählen

Group 22

4 Tage Aufenthalt

  • 2 Mär 2020 bis einschl. 5 Mär 2020

kurzer Besuch

  • 7 Mär 2020
  • 10 Mär 2020
  • 17 Mär 2020
  • 24 Mär 2020
  • 31 Mär 2020
  • 7 Apr 2020
  • 14 Apr 2020
  • 28 Apr 2020
  • 12 Mai 2020
  • 19 Mai 2020
  • 26 Mai 2020

Nachuntersuchung

  • 1 Sep 2020
€ 4.133,- Wählen

Group 23

4 Tage Aufenthalt

  • 5 Mär 2020 bis einschl. 8 Mär 2020

kurzer Besuch

  • 10 Mär 2020
  • 13 Mär 2020
  • 20 Mär 2020
  • 27 Mär 2020
  • 3 Apr 2020
  • 10 Apr 2020
  • 17 Apr 2020
  • 1 Mai 2020
  • 15 Mai 2020
  • 22 Mai 2020
  • 29 Mai 2020

Nachuntersuchung

  • 4 Sep 2020
€ 4.133,- Wählen

Group 25

4 Tage Aufenthalt

  • 12 Mär 2020 bis einschl. 15 Mär 2020

kurzer Besuch

  • 17 Mär 2020
  • 20 Mär 2020
  • 27 Mär 2020
  • 3 Apr 2020
  • 10 Apr 2020
  • 17 Apr 2020
  • 24 Apr 2020
  • 8 Mai 2020
  • 22 Mai 2020
  • 29 Mai 2020
  • 5 Jun 2020

Nachuntersuchung

  • 11 Sep 2020
€ 4.133,- Wählen

Group 27

4 Tage Aufenthalt

  • 19 Mär 2020 bis einschl. 22 Mär 2020

kurzer Besuch

  • 24 Mär 2020
  • 27 Mär 2020
  • 3 Apr 2020
  • 10 Apr 2020
  • 17 Apr 2020
  • 24 Apr 2020
  • 1 Mai 2020
  • 15 Mai 2020
  • 29 Mai 2020
  • 5 Jun 2020
  • 12 Jun 2020

Nachuntersuchung

  • 18 Sep 2020
€ 4.133,- Wählen

Group 28

4 Tage Aufenthalt

  • 23 Mär 2020 bis einschl. 26 Mär 2020

kurzer Besuch

  • 28 Mär 2020
  • 31 Mär 2020
  • 7 Apr 2020
  • 14 Apr 2020
  • 21 Apr 2020
  • 28 Apr 2020
  • 5 Mai 2020
  • 19 Mai 2020
  • 2 Jun 2020
  • 9 Jun 2020
  • 16 Jun 2020

Nachuntersuchung

  • 22 Sep 2020
€ 4.133,- Wählen

Group 29

4 Tage Aufenthalt

  • 26 Mär 2020 bis einschl. 29 Mär 2020

kurzer Besuch

  • 31 Mär 2020
  • 3 Apr 2020
  • 10 Apr 2020
  • 17 Apr 2020
  • 24 Apr 2020
  • 1 Mai 2020
  • 8 Mai 2020
  • 22 Mai 2020
  • 5 Jun 2020
  • 12 Jun 2020
  • 19 Jun 2020

Nachuntersuchung

  • 25 Sep 2020
€ 4.133,- Wählen

Group 30

4 Tage Aufenthalt

  • 30 Mär 2020 bis einschl. 2 Apr 2020

kurzer Besuch

  • 4 Apr 2020
  • 7 Apr 2020
  • 14 Apr 2020
  • 21 Apr 2020
  • 28 Apr 2020
  • 5 Mai 2020
  • 12 Mai 2020
  • 26 Mai 2020
  • 9 Jun 2020
  • 16 Jun 2020
  • 23 Jun 2020

Nachuntersuchung

  • 29 Sep 2020
€ 4.133,- Wählen
Volle Studien anzeigen

Group 1

Voll
€ 4.133,- Wählen

Group 2

Voll
€ 4.133,- Wählen

Group 3

Voll
€ 4.133,- Wählen

Group 4

Voll
€ 4.133,- Wählen

Group 5

Voll
€ 4.133,- Wählen

Group 6

Voll
€ 4.133,- Wählen

Group 7

Voll
€ 4.133,- Wählen

Group 8

Voll
€ 4.133,- Wählen

Group 9

Voll

4 Tage Aufenthalt

  • 17 Jan 2020 bis einschl. 20 Jan 2020

kurzer Besuch

  • 22 Jan 2020
  • 25 Jan 2020
  • 1 Feb 2020
  • 8 Feb 2020
  • 15 Feb 2020
  • 22 Feb 2020
  • 29 Feb 2020
  • 14 Mär 2020
  • 28 Mär 2020
  • 4 Apr 2020
  • 11 Apr 2020

Nachuntersuchung

  • 18 Jul 2020
€ 4.133,- Wählen

Group 10

Voll

4 Tage Aufenthalt

  • 20 Jan 2020 bis einschl. 23 Jan 2020

kurzer Besuch

  • 25 Jan 2020
  • 28 Jan 2020
  • 4 Feb 2020
  • 11 Feb 2020
  • 18 Feb 2020
  • 25 Feb 2020
  • 3 Mär 2020
  • 17 Mär 2020
  • 31 Mär 2020
  • 7 Apr 2020
  • 14 Apr 2020

Nachuntersuchung

  • 21 Jul 2020
€ 4.133,- Wählen

Group 11

Voll

4 Tage Aufenthalt

  • 23 Jan 2020 bis einschl. 26 Jan 2020

kurzer Besuch

  • 28 Jan 2020
  • 31 Jan 2020
  • 7 Feb 2020
  • 14 Feb 2020
  • 21 Feb 2020
  • 28 Feb 2020
  • 6 Mär 2020
  • 20 Mär 2020
  • 3 Apr 2020
  • 10 Apr 2020
  • 17 Apr 2020

Nachuntersuchung

  • 24 Jul 2020
€ 4.133,- Wählen

Group 12

Voll

4 Tage Aufenthalt

  • 27 Jan 2020 bis einschl. 30 Jan 2020

kurzer Besuch

  • 1 Feb 2020
  • 4 Feb 2020
  • 11 Feb 2020
  • 18 Feb 2020
  • 25 Feb 2020
  • 3 Mär 2020
  • 10 Mär 2020
  • 24 Mär 2020
  • 7 Apr 2020
  • 14 Apr 2020
  • 21 Apr 2020

Nachuntersuchung

  • 28 Jul 2020
€ 4.133,- Wählen

Group 14

Voll

4 Tage Aufenthalt

  • 3 Feb 2020 bis einschl. 6 Feb 2020

kurzer Besuch

  • 8 Feb 2020
  • 11 Feb 2020
  • 18 Feb 2020
  • 25 Feb 2020
  • 3 Mär 2020
  • 10 Mär 2020
  • 17 Mär 2020
  • 31 Mär 2020
  • 14 Apr 2020
  • 21 Apr 2020
  • 28 Apr 2020

Nachuntersuchung

  • 4 Aug 2020
€ 4.133,- Wählen

Group 15

Voll

4 Tage Aufenthalt

  • 6 Feb 2020 bis einschl. 9 Feb 2020

kurzer Besuch

  • 11 Feb 2020
  • 14 Feb 2020
  • 21 Feb 2020
  • 28 Feb 2020
  • 6 Mär 2020
  • 13 Mär 2020
  • 20 Mär 2020
  • 3 Apr 2020
  • 17 Apr 2020
  • 24 Apr 2020
  • 1 Mai 2020

Nachuntersuchung

  • 7 Aug 2020
€ 4.133,- Wählen

Group 16

Voll

4 Tage Aufenthalt

  • 10 Feb 2020 bis einschl. 13 Feb 2020

kurzer Besuch

  • 15 Feb 2020
  • 18 Feb 2020
  • 25 Feb 2020
  • 3 Mär 2020
  • 10 Mär 2020
  • 17 Mär 2020
  • 24 Mär 2020
  • 7 Apr 2020
  • 21 Apr 2020
  • 28 Apr 2020
  • 5 Mai 2020

Nachuntersuchung

  • 11 Aug 2020
€ 4.133,- Wählen

Group 17

Voll

4 Tage Aufenthalt

  • 13 Feb 2020 bis einschl. 16 Feb 2020

kurzer Besuch

  • 18 Feb 2020
  • 21 Feb 2020
  • 28 Feb 2020
  • 6 Mär 2020
  • 13 Mär 2020
  • 20 Mär 2020
  • 27 Mär 2020
  • 10 Apr 2020
  • 24 Apr 2020
  • 1 Mai 2020
  • 8 Mai 2020

Nachuntersuchung

  • 14 Aug 2020
€ 4.133,- Wählen

Group 18

Voll

4 Tage Aufenthalt

  • 17 Feb 2020 bis einschl. 20 Feb 2020

kurzer Besuch

  • 22 Feb 2020
  • 25 Feb 2020
  • 3 Mär 2020
  • 10 Mär 2020
  • 17 Mär 2020
  • 24 Mär 2020
  • 31 Mär 2020
  • 14 Apr 2020
  • 28 Apr 2020
  • 5 Mai 2020
  • 12 Mai 2020

Nachuntersuchung

  • 18 Aug 2020
€ 4.133,- Wählen

Group 19

Voll

4 Tage Aufenthalt

  • 20 Feb 2020 bis einschl. 23 Feb 2020

kurzer Besuch

  • 25 Feb 2020
  • 28 Feb 2020
  • 6 Mär 2020
  • 13 Mär 2020
  • 20 Mär 2020
  • 27 Mär 2020
  • 3 Apr 2020
  • 17 Apr 2020
  • 1 Mai 2020
  • 8 Mai 2020
  • 15 Mai 2020

Nachuntersuchung

  • 21 Aug 2020
€ 4.133,- Wählen

Group 24

Voll

4 Tage Aufenthalt

  • 9 Mär 2020 bis einschl. 12 Mär 2020

kurzer Besuch

  • 14 Mär 2020
  • 17 Mär 2020
  • 24 Mär 2020
  • 31 Mär 2020
  • 7 Apr 2020
  • 14 Apr 2020
  • 21 Apr 2020
  • 5 Mai 2020
  • 19 Mai 2020
  • 26 Mai 2020
  • 2 Jun 2020

Nachuntersuchung

  • 8 Sep 2020
€ 4.133,- Wählen