Die Studie

Die Studie ist in Englisch. Um Teil zu nehmen, müssen Sie der englischen oder holländischen Sprache mächtig sein.

Study of a new compound that is being developed for the treatment of behavioral problems in autism spectrum disorders (ASD).

Particulars:

  • Your Body Mass Index (BMI) is between 18 and 30 kg/m2. The BMI reflects the relation between your body weight in kilograms and your height in meters.
  • You are a healthy male.
  • You are between 18 and 54 years.
  • Only non-smokers are allowed to participate in this study.
  • You have not participated in any other drug study (counting from the follow-up of the previous study) within 90 days prior to the screening of this study. For specific studies this could be 6 months. You can call us to get more information about this.
  • As a male, you are only allowed to participate in this study if:
    • You use a condom;
    • or your female partner is postmenopausal (at least 12 months without menstruation) or has been surgically sterilized (at least 6 months);
    • or you are only sexually active with a male;
    • or you are true abstinent (not sexually active) in accordance with your lifestyle.
  • To determine if you are eligible to participate in this study, you will undergo a medical screening.

Zeitraum

The study consists of two parts, part 1 and part 2. You are only allowed to participate in one part. Both parts consist of a period of 9 days (8 nights) followed by a period of 14 days (13 nights) in our research facility in Groningen. You return to your home in between the two periods. After the last period of your stay you will have to return once for your follow-up visit, which will take place 10 – 14 days after the last administration of the study compound. If the dates change, you will be notified as soon as possible.

Group 9 days and 14 days stay Follow up
Group 1a 17 Aug 2020 up to and including 25 Aug 2020
1 Sep 2020 up to and including 14 Sep 2020
Follow-up by appointment between 19 - 23 September 2020
Group 1b 25 Aug 2020 up to and including 2 Sep 2020
9 Sep 2020 up to and including 22 Sep 2020
Follow-up by appointment between 27 September - 01 October 2020
Group 2a 7 Sep 2020 up to and including 15 Sep 2020
22 Sep 2020 up to and including 5 Oct 2020
Follow-up on appointment between 07 - 11 October 2020

Aufwandsentschädigung

You will receive a gross compensation of € 3376 for full participation. 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, irrespective of the method of transportation.