Die Studie
- You are a healthy male or female
- You are between 18 and 55 years old
- Your Body Mass Index (BMI) is between 18.0 and 30.0 kg/m2.
- You can only participate in this trial if you do not smoke or use other nicotine-containing products.
Note:
- You cannot participate in the trial if you have participated in another clinical study in the 30 days prior to this trial (counting from the follow-up visit to the screening visit).
- To determine if you are suitable to participate in this study, 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:
- You are using adequate contraception (for example the contraceptive pill or 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 only have sexual contact with women;
- You are not sexually active according to your lifestyle.
As a male you can only participate if you meet one of the following conditions:
- You are using a condom in combination with a contraception method used by your female partner (for example the contraceptive pill or intra-uterine device);
- You have been sterilized or your female partner has been sterilized or is postmenopausal (no period for at least 12 months);
- You only have sexual contact with men;
- You are not sexually active according to your lifestyle.
Zeitraum
The study consists of 3 parts: part A and part B. You can only participate in 1 group of 1 part.
- Part A consists of 1 period during which you will stay in the research facility in Groningen for 4 days (3 nights).
- For 1 group of part A the trial consists of 4 periods of 4 days (3 nights) each. For some participants of this group the study will stop after the first period. If this is the case, you will be informed during the study.
- Part B consists of 1 period during which you will stay in the research facility in Groningen for 17 days (16 nights).
The follow-up visit will take place for each part between 5 to 10 days after your (final) departure from the research facility.
Note: You must be available for all dates to be able to participate in this trial. These are the currently planned dates; however, these may be subject to change.
| Group A6 | |
| stay | - 1 Sep 2022 up to and including 4 Sep 2022
|
| follow-up | - by appointment between 9 Sep 2022 up to and including 14 Sep 2022
|
| Group B1a | |
| stay | - 27 Sep 2022 up to and including 13 Oct 2022
|
| follow-up | - by appointment between 18 Oct 2022 up to and including 23 Oct 2022
|
| Group B1b | |
| stay | - 28 Sep 2022 up to and including 14 Oct 2022
|
| follow-up | - by appointment between 19 Oct 2022 up to and including 24 Oct 2022
|
For some participants in this group, the study ends after the second period. If this is the case, you will be informed during the clinical trial.
Aufwandsentschädigung
- For participating in part A with 4 periods you will receive a gross compensation of € 3445.
- For participation in part B you will receive a gross compensation of € 3055.
Travel 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 round trip, regardless of the mode of transportation.
