• The study compound is a new compound that may potentially be used for the treatment of bladder pain syndrome.  Bladder pain syndrome is a condition that cannot be cured. The disease has no identifiable cause (such as bacteria in a ‘normal’ bladder infection). Symptoms of bladder pain syndrome include persistent pain in the pelvic area and urinary tract complaints. These may be the result of hypersensitivity of the nerves.
• The study compound has been administered to humans before.
• In group 1 the study compound will be given twice, once with a high fat breakfast and once without breakfast. In group 2 you will receive the study compound once. In group 3 to 5 you will be given the study compound twice a day for 14 days. The study compound will be given as capsules to be taken by mouth with water

The compound has already been tested in healthy individuals. It has also been studied extensively in the laboratory and in animals. The following side effects were observed in trials with healthy individuals: headache, back pain, limb discomfort (for example muscle pain, tingling, numbness, weakness, stiffness or cramping) and nausea.

You may also experience other, yet unknown, side effects. Prior to the medical screening, you will receive written information about the trial, 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 is clear to you, you can decide to give written consent to participate in the trial. The medical screening will only take place after you have given written consent to participate in the trial. We want to emphasize that even after giving written consent, participation in any clinical trial is voluntary. You can decide at any time not to participate or to stop the medical screening or the trial. 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 55 years old.
• Your weight is at least 50 kg and at most 110 kg and your Body Mass Index (BMI) is at least 18.5 and at most 29.9 kg/m2. 
• Both non-smokers and light smokers or occasional smokers (less than 5 cigarettes per day) are allowed to participate in this clinical trial. 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 2 months 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.
• As a female you can only participate if you are not pregnant, not breastfeeding and meet one of the following conditions:
  • You are using hormonal contraception (for example the contraceptive pill or 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 only sexually active with a partner of the same sex;
  • You are not sexually active according to your lifestyle.
• As a male you can only participate if you meet one of the following conditions:
  • You are using a condom with your fertile 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.

Group 1 and 2

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

Group 3 to 5

The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 19 days (18 nights). The follow-up visit will take place during your departure from the research facility.

Note: You must be available for all dates to be able to participate in this clinical trial.