• The study compound is a new compound that may potentially be used for the treatment of protracted iron overload. Iron plays an important role in many processes in the body, such as oxygen transport, energy production, and immune system response. In iron overload, there is too much iron in the body. The body is no longer able to eliminate this excess iron on its own, causing it to be stored in the liver, the heart, and other organs. If this accumulation continues, it can lead to serious damage and other conditions. The study compound binds to iron and promotes its excretion from the body. It is intended for patients who require blood transfusions. During a blood transfusion, a person receives blood from someone else via an infusion, but with each transfusion a large amount of iron also enters the body, which can again lead to iron overload.
• In this trial, we will investigate how quickly and to what extent the study compound is absorbed by the body. We will test the compound in two different forms in healthy people. We will also examine the effect of food intake on how the body processes the compound. Furthermore, we will investigate how safe the study compound is and how well it is tolerated.
• You will be given the study compound three times (once per stay) as follows:
  • once as oral tablets after fasting overnight for 10 hours (no eating or drinking, except water)
  • once as oral capsules after fasting overnight for 10 hours (no eating or drinking, except water)
  • once as oral tablets after a high-fat breakfast. The high-fat breakfast is a large breakfast which must be consumed entirely. It can be difficult to consume the entire breakfast, particularly for light eaters. Please contact us for more information.
• During the screening, you will have to undergo a swallowing test. This is to determine whether you are able and willing to swallow a large number of capsules and tablets.
• The compound has already been tested in healthy individuals and patients with iron overload after a blood transfusion. In these clinical trials, the following side-effect was observed most often: increases in certain blood values that indicate kidney toxicity were seen in patients. These values returned to normal after administration of the study compound was stopped. No indications of kidney damage have been seen in patients who received multiple doses of the study compound given three times per week. 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 55 kg and your Body Mass Index (BMI) is at least 18.5 and at most 25.0 kg/m². The BMI shows the relationship between body weight in kilograms and height in meters.
• You did not smoke and did not use any nicotine-containing products in the 6 months prior to screening.

Note:

• You cannot participate in this trial if you have participated in another clinical trial within 3 months prior to the admission date. In some cases, this period may be longer. Please contact us for more information.
• 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 use hormonal contraception (for example the contraceptive pill or intra-uterine device containing hormones);
  • You use a copper intra-uterine device;
  • 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:

• Your female partner uses a contraception method;
• 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.

The trial consists of 3 periods in which you will stay in the research facility in Groningen for 6 days (5 nights) per period. The follow-up visit will take place 2 to 4 days after the last 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. The location in Groningen is Van Swietenlaan 6