Group A1a
- 13 up to and including 19 Dezember
Period(s) of stay (7 days)
- 13 up to and including 19 Dezember
- 12 Januar (phone call)
Follow-up
- 12 Januar (phone call)
- €1668,-
Compensation
- €1668,-
Find out if you qualify for this trial
- You are a healthy male or female
- You are between 18 and 55 years old
- You weigh more than 50 kg
- Your Body Mass Index (BMI) is between 18.5 and 32 kg/m2
Good to know about this trial
- Within this cinical trial interrem payment is possible.
- The medication will be given in the form of a capsule for swallowing.
- Smokers can participate in this research.
Study groups
Register without obligation for the group of your preference
The research physician about this research
Additional information
The study compound is being developed for the treatment of heart failure. In this clinical trial, we investigate how the study compound is processed and eliminated by the body and how well it is tolerated when it is used by healthy participants.
Für Deutschland: Bitte beachten Sie: Die Arzneimittelstudien finden im niederländischen Groningen statt. Sie müssen Englisch oder Niederländisch sprechen, verstehen und lesen können, um an einer Studie teilnehmen zu können.
Who can participate?
Target group
- You are a healthy male or female.
- You are at least 18 and at most 55 years old.
- Your weight is at least 50 kg
- Your Body Mass Index (BMI) is:
- at least 18 and at most 32 kg/m2 for part A, B and C.
- at least 18 and at most 30 kg/m2 for part D.
- Both non-smokers and light smokers or occasional smokers are allowed to participate in this clinical trial (maximum of 5 cigarettes per day). During your stay in our research facility, you are not allowed to smoke.
Note:
- You cannot participate in the trial if you have participated in another clinical trial in the 30 days (about 4 and a half weeks) prior to the screening of this clinical trial (counting from the last dosing).
- To determine if you are suitable to participate in this trial, you will undergo a medical screening.
As a female you can only participate if you meet one of the following conditions:
- You have passed menopause (no periods for at least 12 months);
- You have been sterilized or due to other reasons are sterile.
As a male you can only participate if you meet one of the following conditions;
- You are using a condom during sexual intercourse;
- You are not sexually active according to your lifestyle.
What is the compensation for this research?
Compensation
For participation in one of the groups of part A of the trial, you will receive a gross compensation of €1668.
For participation in one of the groups of part B of the trial, you will receive a gross compensation of €3199.
For participation in one of the groups of part C of the trial, you will receive a gross compensation of €3850.
For participation in one of the groups of part D of the trial, you will receive a gross compensation of €4718.
Travel expenses will be reimbursed based on the distance traveled (€ 0.21 net per kilometer) with a minimum of € 13 and a maximum of € 176.40 (840 kilometers) per round trip, regardless of the mode of transportation
How long does this research take?
Period of stay and research
The trial consists of 4 parts: part A, part B, part C and part D. You can only participate in one part of this clinical trial.
Part A consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 7 days (6 nights). The follow-up visit will take place on the day of your departure from the research facility. 21 to 27 days (about 4 weeks) after your departure from the research facility, you will be contacted by phone for some questions.
Part B consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 13 days (12 nights). The follow-up visit will take place 4 to 5 days after your departure from the research facility. 20 to 26 days (about 3 and a half weeks) after the follow-up visit, you will be contacted by phone for some questions.
Part C consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 16 days (15 nights). The follow-up visit will take place 4 to 5 days after your departure from the research facility. 20 to 26 days (about 3 and a half weeks) after the follow-up visit, you will be contacted by phone for some questions.
Part D consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 20 days (19 nights). The follow-up visit will take place 3 to 4 days after your departure from the research facility. 21 to 27 days (about 4 weeks) after the follow-up visit, you will be contacted by phone for some questions.
Note: You must be available for all dates to be able to participate in this clinical trial.
Particularities
The trial consists of 4 parts: part A, part B, part C and part D.
In part A you receive the compound once.
In part B you receive the compound once or twice daily for 10 days (about 1 and a half weeks).
In part C you receive the compound twice daily for 14 days (about 2 weeks).
In part D you receive the compound twice in combination with an approved medicine.
- For part A, part B and part D: During the trial your heart rhythm and blood pressure will be continuously monitored during certain periods.
- For all parts: on some days, during the trial, you have to fast up to 14 hours.
Frequently asked questions
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Sie dürfen höchstens 4 Mal pro Jahr an einer Studie teilnehmen. Zwischen zwei Studien müssen mindestens 30 Tage liegen. Für einige Studien gilt eine längere Wartezeit.
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Während der Studie können leichte Beschwerden wie Kopfschmerzen oder Übelkeit auftreten. Dies kann durch das Medikament verursacht werden. Aber es kann zum Beispiel auch daran liegen, dass Sie für die Studie nüchtern bleiben müssen. Diese Nebenwirkungen sind unangenehm, aber glücklicherweise nicht gefährlich.
Bevor ein Medikament am Menschen erprobt werden darf, wurde es bereits umfassend in einem Labor getestet. So lässt sich gut vorhersagen, welche Nebenwirkungen eventuell bei Ihnen auftreten werden, damit Sie sich darauf einstellen können. So kommt es fast nie vor, dass Teilnehmer unter unerwarteten Nebenwirkungen leiden.
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Eine Studie umfasst in der Regel fünf bis zwölf Teilnehmer. Die Gruppen werden so zusammengestellt, dass sie optimal zu den Anforderungen der Studie passen. Diese Anforderungen sind in jeder Studie beschrieben. Sehen Sie sich alle aktuellen Studien an.
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ICON führt häufig Studien mit radioaktiv markierten Medikamenten durch. Damit können wir untersuchen, wie und wie schnell das Medikament im Körper aufgenommen, verarbeitet und ausgeschieden wird. Bei einer Studie mit radioaktiv markiertem Medikament ist das Risiko von Nebenwirkungen geringer als bei anderen Studien. In diesen Studien wird eine viel geringere Dosis verabreicht. Erfahren Sie mehr über Studien mit radioaktiv markierten Medikamenten.