• HIV is a virus that affects the immune system, especially the cells that help the body fight infections. In the case of infections, viruses, bacteria, fungi or parasites (so-called 'pathogens') enter the body and start to grow. If the immune system is strong enough, such a pathogen is less likely to cause an infection. However if the immune system is weakened, the body can no longer protect itself properly and someone becomes ill. If someone is not treated for HIV, this person can therefore become more susceptible to diseases.
• You will be administered the study compound on two different days. During the first dose, you will receive the study compound as a tablet taken by mouth, and you will receive a solution of the study compound administered directly into a blood vessel via an infusion. During the second dose, you will receive the study compound in the form of a cloudy drink.
• This is a clinical trial with a radioactive (14C) labeled compound. Radioactively labeling a compound is done to be able to study how quickly and to what extent the compound is absorbed, converted and excreted by the body. The radioactivity disappears from the body at the same time as the compound through the feces, urine and/or breath. The compound has a negligible amount of radiation burden. Please contact us for more information.
• To measure radioactivity levels in your body, blood, urine and feces will be collected during the trial.
• The compound has already been tested in healthy individuals. In these studies, the compound was assessed as safe and well tolerated. The following side-effects were observed most often: headache, nausea, constipation (difficulty passing bowel movements) and diarrhea. You may 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 Body Mass Index (BMI) is at least 18.0 and at most 32.0 kg/m². 
• You do not smoke and do not use any nicotine-containing products.

• As a female you can only participate if you are not pregnant, not breast feeding and meet one of the following conditions:
  • You have passed menopause (no periods for at least 12 months);
  • You have been sterilized..
• As a male you can only participate if you meet one of the following conditions:
  • You are using a condom with your female partner, until the last visit of the study;
  • 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.

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). For some clinical trials this period could be longer. Please contact us for more information.
• You can only participate in this trial if you have not participated in another trial with a radioactive (14C) labeled compound in the past 12 months.
• 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 29 days (28 nights).

The follow-up visit will take place 7 days after your final departure from the research facility. If not enough radioactivity has left your body after 28 days, there will be one or two more 24-hour overnight visits before the follow-up visit .

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