Die Studie
- You are a healthy male or female.
- You are between 18 and 60 years old.
- Your Body Mass Index (BMI) is between 18.0 and 32.0 kg/m2.
- Both non-smokers and light smokers or occasional smokers (who smoke no more than 5 cigarettes per day) are allowed to participate in this clinical trial. From one week prior to admission and 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 screening appointment (counting from the last dosing).
- COVID-19 vaccines are allowed up to the day before your stay at our clinic.
- Do you have a vaccination appointment planned, or have you recently been vaccinated and do you want to know whether you can participate in this study? Feel free to contact us to discuss the possibilities.
- 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 meet one of the following conditions:
- You are using hormonal contraception (for example the contraceptive pill or intra-uterine device containing hormones) from at least 4 weeks prior to admission;
- You are using a copper intra-uterine device from at least 4 weeks prior to admission.
- 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 fertile female partner from at least 4 weeks prior to your admission;
- 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 A: The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 6 days (5 nights), followed by 5 short visits including the follow-up visit.
Aufwandsentschädigung
- You will receive a gross compensation of € 2629 for participation in one of the groups of part A.
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.
