Knochenkrankheiten

Important information about this study

• In part 1 of the study, the study compound is administered once.
• As a smoker you can also participate in this medical trial.
• You will contribute significantly to the development of medications for people with bone diseases. For example, in the treatment of bone fracture healing.

Who can participate?

• You are a healthy male or female.
• You are between 22 and 65 years old.
• Your weight is at least 50.0 kg and at most 110.0 kg and your Body Mass Index (BMI) is between 18.0 and 30.0 kg/m2. 
• Both non-smokers and light smokers or occasional smokers are allowed to participate in this clinical trial (at most 5 cigarettes daily). During your stay in our research facility you are not allowed to smoke.

Note: 

• You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the first compound administration in this clinical trial (counting from the follow-up).
• To determine if you are suitable to participate in this trial, 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 continuous hormonal contraception (the pill or a hormonal IUD) in combination with a condom, cervical cap, or diaphragm used by your male partner;
• You have passed the menopause (no periods for at least 12 months);
• You have been sterilized (ovariectomy).

As a male you can only participate if you meet one of the following conditions:

• You are using a condom in combination with an additional contraception method used by your female partner;
• You have been sterilized or your female partner is sterilized or has passed the menopause (no periods for at least 12 months);
• You are not sexually active according to your lifestyle;
• You are only sexually active with a partner of the same sex.