The study compound may potentially be used for the treatment of Parkinson’s disease and Parkinsonian syndromes. Parkinsonian syndromes refer to a collective term for syndromes that resemble Parkinson’s disease but do not have the same cause or course. The study compound reduces the amount of protein. An alteration in this protein, making it over-active, is a cause of Parkinson’s disease. Changes in this protein have also been found in patients with parkinsonism. 

In this study we will investigate how quickly and to what extent the study compound is absorbed, transported, and eliminated from the body when it is given with and without food, and when this is given together with an anti-acid. We will also investigate how safe the study compound is and how well it is tolerated when it is used by healthy persons.

In part A, you will receive the study compound once with breakfast and once without breakfast. This is a high-fat breakfast with a fixed composition, which must be started exactly on time and must be finished within 30 minutes.

In part B, you will receive the study compound once without the anti-acid and once with the anti-acid. The anti-acid is an approved medicine that you will take orally as a capsule with water. Each period, you will be given breakfast once with a fixed composition, which must be started exactly on time and must be finished within 30 minutes.

The compound has already been tested as single and multiple doses in healthy individuals and patients with Parkinson’s disease. In these clinical trials, the following side-effects were observed most often: mild fatigue and headache. 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 65 years old.
• Your weight is at least 50 kg and at most 115 kg and your Body Mass Index (BMI) is at least 18.0 and at most 31.9 kg/m². The BMI shows the relationship between body weight in kilograms and height in meters.
• You have not smoked or used nicotine-containing products 60 days prior to the first compound administration.

Note:

• You cannot participate in the trial if you have participated in another clinical trial in the 3 months prior to the first compound administration in this clinical trial (counting from the last compound administration of the previous study).
• 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 hormonal contraception (for example the contraceptive pill or intra-uterine device containing hormones) in combination with a condom for up to 210 days after the last dose;
  • 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 in combination with an additional contraception method used by your female partner for up to 120 days after the last dose;
  • You have been sterilized, or your female partner is sterilized or has passed the menopause (no periods for at least 12 months);
  • You are only sexually active with a partner of the same sex;
  • You are not sexually active according to your lifestyle.

Part A of the trial consists of 2 periods during which you will stay in the research facility in Groningen for 6 days (5 nights) per period, followed by one short visit after each period. The follow-up visit will take place 6 or 7 days after the last short visit.

Part B of the trial consists of 2 periods during which you will stay in the research facility in Groningen for 6 days (5 nights) during the first period and 10 days (9 nights) during the second period, followed by one short visit after each period. The follow-up visit will take place 7 days after the last short visit.

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