• In this trial, we look at the effect of administering 2 compounds that are already available on the market.
• One compound is given as an intravenous infusion (solution of the compound administered directly into a blood vessel) every 8 hours for 4 days. The infusion lasts 2 hours each time.
• The other compound is given as a tablet that you must swallow with 240 ml of water. This compound is administered twice in total, on different days.

Both compounds are already on the market and most of the side effects are known.

• Compound 1: based on studies with the compound in adult patients, the most common side effects that occurred in 1% or more of patients were: nausea, diarrhea, vomiting, headache, taste disorder, rash, inflammation of a vein, decreased sodium levels in the blood and/or increased liver enzyme levels in the blood (this says something about the functioning of the liver).
• Compound 2: the most common side effects that occur in 1% or more of people are joint pain, muscle pain, constipation, diarrhea, indigestion, nausea and/or headache.

Prior to the medical screening, you will receive written information about the study, which also describes the possible side effects. This information will also be discussed with you at the start of the medical screening. You can then ask questions to the screening physician or nurse. Once everything has been clarified, you can decide to give written consent to participate in the trial. The medical screening will only take place after you have done so. We want to emphasize that even after giving written consent, participation in any study is voluntary. You can decide at any time not to participate or to stop the medical screening or the study. You do not need to provide a reason for why you no longer wish to participate.

• You are a healthy male or female.
• You are at least 18 and at most 65 years old.
• Your Body Mass Index (BMI) is at least 18.0 and at most 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 per day). During your stay in our research facility, you are not allowed to smoke.
• As a female you can only participate if you are not pregnant, not breastfeeding and meet one of the following conditions, from at least 4 weeks prior to the first compound administration in this clinical trial:
  • You are using hormonal contraception (for example the contraceptive pill or an intra-uterine device containing hormones) in combination with a condom;
  • You are using a copper intra-uterine device in combination with a condom;
  • You have passed the menopause (no periods for at least 12 months);
  • You have been sterilized or your male partner has been sterilized;
  • You are not sexually active according to your lifestyle;
  • You are only sexually active with a partner of the same sex.

• 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 (for example the contraceptive pill or an intra-uterine device containing hormones);
  • 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.

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 visit).

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.

The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 10 days (9 nights). The follow-up visit will take place 5 – 9 days after your departure from the research facility.

Note: You must be available for all dates to be able to participate in this clinical trial. The current dates of the clinical trial will be published on our website.