Study of a new compound that is being developed for the treatment of inflammatory bowel diseases
- You do not smoke.
- You are between 18 and 55 years old.
- Your Body Mass Index (BMI) is between 18 and 30 kg/m2.
- If you have a female partner of childbearing potential, you must use contraceptive measures.
- Women can only participate if they are surgically sterilized or postmenopausal (12 months without menses).
- You have not participated in any other drug study within 12 weeks preceding the first administration of the study compound.
- To determine if you are suitable to participate in this study, you will undergo a medical screening.
You will receive a gross compensation of € 3,227.- for participation in part 4 (group Q, R or S).
Travelling expenses will be reimbursed based on the distance traveled (€0.19 net per kilometer) with a minimum of €12.- and a maximum of €160.- (840 kilometers) per return, regardless of the mode of transportation.
Period of stay and research
Part 4 of this study (group Q, R and S) consists of 1 period during which you will stay in our research facility in Groningen for 22 days (21 nights). Finally, for all groups there will be a follow-up visit between 12 and 16 days after final administration of the study drug.
Please note: You have to be available for all dates for the group of choice to be able to participate in this study. The actual dates will be published on our website. These are the currently planned dates; however, these may be subject to change.
Type of study
Soon a research study will start at PRA with a new study drug that may eventually be used for the treatment of inflammatory bowel diseases. The purpose of the study is to investigate to what extent the study medication is safe and tolerated. It will also be investigated how quickly and to what extent the study medication is absorbed and eliminated from the body. In addition, the effect of a high calorie/high fat breakfast will be investigated in part 3.
The study drug is not registered as a drug and has not been given to humans before. The study will only take place after it has been approved by the Independent Ethics Committee.
Setup and duration of the study
The study will consist of 3 parts. You can participate in one of these parts. Part 1 and 2 consist of 1 period during which you will stay in the clinical research center in Groningen for 6 days (5 nights). Part 3 consists of 2 periods during which you will stay in the clinical research center in Groningen for 5 days (4 nights) each. These periods are separated by a 9-day wash-out period. Before the start of the study you will visit the medical screening centre. A follow up visit will be conducted between 12 and 16 days after the last dosing. At screening, entry in the clinic and the follow-up visit you must have fasted for 4 hours.
In part 1 and 2, you will receive the study drug or placebo once in the form of a capsule. In part 3, you will receive the study drug on two separate occasions, once in every period in the form of a capsule. Blood and urine samples will be collected regularly during the study.
Risks and medical supervision
The compound can possibly inhibit an enzyme that regulates the immune response of the body. The compound will be administered to man for the first time in this study, side effects in man have not been reported to date. However, the compound has been studied extensively in the laboratory and in animals. In rats who received the compound daily for 6 weeks, some adverse findings were observed in bone, heart and kidneys. In dogs some adverse effects were also observed in the heart after daily dosing for 6 weeks. After single administration and after 7 days of dosing, no adverse effects were observed. These side effects are not likely to occur in this single, and low dose study.
Besides, you will be under strict medical supervision during the study. Before the study and at the end of the study you will undergo an extensive medical screening.
Conditions for participation
You are a healthy male between 18 and 55 years old. You can only take part in the study if you do not smoke. If you have a female partner of childbearing potential, you must use contraceptive measures. This means that you should use a condom in combination with a (hormonal) contraceptive by the female partner. The study will be executed under standardized conditions. Use of your own medication, alcohol, regular coffee and tea, cola, power drinks, chocolate (including products made of chocolate), grapefruit (juice) and tobacco products during the study is not allowed. Also, before the study there will be restrictions for these products. Use of decaffeinated coffee and (some) teas without caffeine is allowed.
Before you are allowed to take part in the study, you will be medically screened; this screening will take place within three weeks before the start of the study.
Sign up for one of the following study groups
22 days stay
- 9 Jan 2020 up to and including 30 Jan 2020
22 days stay
- 18 Nov 2019 up to and including 9 Dec 2019
2× 8 days stay
- 13 Aug 2019 up to and including 20 Aug 2019
- 26 Aug 2019 up to and including 2 Sep 2019
2× 8 days stay
- 20 Aug 2019 up to and including 27 Aug 2019
- 3 Sep 2019 up to and including 10 Sep 2019