Die Studie

Study of a new compound that is being developed for the treatment of idiopathic pulmonary fibrosis.

  • We are looking for healthy males between 21 and 65 years old.
  • You do not smoke
  • Your body weight must be at least 50 kg and at most 120 kg and your Body Mass Index (BMI) must be between 18 and 30 kg/m2.
  • If you are a woman, you are only allowed to participate in this study if you have been postmenopausal for at least one year or have been surgically sterilized for at least six months.
  • If you are a man, you are allowed to participate if you use sufficient contraception.
  • You can only participate if you have not received any other investigational study drug within 60 days before dosing in this study.
  • To determine if you are suitable to participate in this study, you will undergo a medical screening. Depending on the availability, this can take place in Groningen or Utrecht.

Zeitraum

The study consists of 2 parts: Part A and Part B.

Part A consists of 1 period during which you will stay in our research facility in Groningen for 7 days (6 nights), followed by 2 short visits. Group A6 of Part A consists of 3 periods. During each period you will stay in our research facility in Groningen for 7 days (6 nights). Each period is followed by 2 short visits.

Part B consists of 1 period during which you will stay in our research facility in Groningen for 20 days (19 nights), followed by 2 short visits. Finally, for all parts there will be a follow up visit within 2 to 6 days after the last short visit. Please note: You have to be available for all dates for the group of choice to be able to participate in this study. The actual study dates will be published on our website. These are the currently planned dates; however, these may be subject to change.

Aufwandsentschädigung

You will receive a gross compensation of €1489 for participation in one of the groups of part A (A1 to A5) of this study. For participation in group A6 of Part A you will receive a gross compensation of €3931. For participation in one of the groups of part B of the study, you will receive a gross compensation of €3197.

Travelling 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.