Herzrhythmusstörungen

Die Studie

Arzneimittelstudie zu einem neuen Medikament, das zur Behandlung von Herzrhythmusstörungen entwickelt wurde.

• 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 and your Body Mass Index (BMI) is at least 18.0 and at most 30.0 kg/m2. 
• Both non-smokers and light smokers or occasional smokers are allowed to participate in this clinical trial (at most 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 prior to the start of this clinical trial (counting from the follow-up visit).
• To determine if you are suitable to participate in this trial, you will undergo a medical screening. Depending on availability, this can be performed in Groningen or in Utrecht.

As a female you can only participate if you are not pregnant, not breast feeding and meet one of the following conditions, from 4 weeks prior to the first compound administration in this trial:

• You are using hormonal contraception (for example the contraceptive pill or intra-uterine device containing hormones) in combination with a condom;
• You are using a copper intra-uterine device in combination with a condom;
• You have passed the menopause (no periods for at least 12 months);
• You have been sterilized or your male partner has been sterilized;
• You are not sexually active according to your lifestyle;
• You are only sexually active with a partner of the same sex.

As a male you can only participate if you meet one of the following conditions:

• You are using a condom in combination with an additional contraception method used by your female partner;
• You have been sterilized or your female partner is sterilized or has passed the menopause (no periods for at least 12 months);
• You are not sexually active according to your lifestyle;
• You are only sexually active with a partner of the same sex.

Zeitraum

Part B: The trial 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 – 6 days after your departure from the research facility.

Note: You must be available for all dates to be able to participate in this clinical trial.

Aufwandsentschädigung

• For participation in one of the groups of part B of the trial, you will receive a gross compensation of € 5.335,-.

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

Zusätzliche Information

In this clinical trial we will investigate how safe the study compound is and how well this is tolerated when it is used by healthy participants. The trial is divided into part A and part B and each part consists of multiple groups. In part A, there is one group in which the effect of food on the study compound will be investigated. You can only participate in one group in one part. 

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.