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Autism Spectrum Disorders

Ort der Studie

 

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

 

Besonderheiten (auf Englisch)

  • You are a healthy male or female.
  • You are between 18 and 54 years old.
  • Only non-smokers are allowed to participate in this study.
  • Your Body Mass Index (BMI) is between 18 and 30 kg/m2.
  • 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.
  • As a female, you are only allowed to participate in part 2 of this study if:
    • You use hormonal contraception or an intrauterine device from screening onwards;
    • or you have been postmenopausal for at least 12 months;
    • or you were surgically sterilized at least 6 months before the start of the study, or your partner is sterilized;
    • or you are only sexually active with a female;
    • or you are true abstinent (not sexually active) in accordance with your lifestyle.
  • Women who are breastfeeding or pregnant cannot participate.
  • To determine if you are eligible to participate in this study, you will undergo a medical screening.

Vergütung (auf Englisch)

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.

 

Periode und Studie (auf Englisch)

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 2b - Males and females

 

9 days en 14 days stay

16 Sep 2020 up to and including 24 Sep 2020

1 Oct 2020 up to and including 14 Oct 2020

 

follow-up

by appointment

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