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 for reduced parathyroid function (hypoparathyroidism).

  • You are a healthy male between 18 and 60 years old
  • You do not smoke
  • Your body weight must be at least 50 kg and your Body Mass Index (BMI) is between 19 and 28 kg/m2, inclusive. 
  • Men can participate in both parts if they use sufficient contraception from admission until 90 days after the last visit:
    • You use a condom in combination with contraception of the female partner (in case your female partner is infertile or you are in a relationship with a man, a condom alone is sufficient), or;
    • You have been sterilized, or;
    • You are sexually abstinent, in accordance with your usual lifestyle.
  • You can only participate in this study if you have not participated in another drug study within at least 30 days before the dosing in this study.
  • To determine if you are suitable to participate in this study, you will undergo a medical screening. Based on availability, this will be performed in Groningen or Utrecht.

Hypoparathyroidism is decreased function of the parathyroid glands with underproduction or no production at all of parathyroid hormone. This lowers the levels of calcium and increases the levels of phosphate in the blood.

Zeitraum

Part A consists of 1 period during which you will stay in our research facility in Groningen for 6 days (5 nights), followed by a 24-hour visit (1 overnight stay). In case this follow-up visit is scheduled the day after discharge, you will stay in the research facility for 8 days (7 nights) in total.

Group 8 days stay
A3a 1 Nov 2020 up to and including 8 Nov 2020
A3b 4 Nov 2020 up to and including 11 Nov 2020

Please note: You have to be available for the whole period of time depending on the group of choice to be able to participate in this study. The current study dates will be published on this page. Here you will also find if you will stay 6 days with a separate follow-up visit or if you will stay 8 days in part A. These are the currently planned dates; however, these may be subject to change.

Aufwandsentschädigung

You will receive a gross compensation of €1196 for participation in one of the groups of part A of this study. In case you remain in the research facility until the follow-up visit, you will receive a gross compensation of €1285. 

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.