Study of a new compound that is being developed for the treatment of inflammatory bowel diseases (e.g. Crohn’s disease or Ulcerative colitis) and rheumatoid arthritis
- You do not smoke
- Your Body Mass Index (BMI) is between 18 and 32 kg/m2. The BMI shows the relation between body weight in kilograms and length in meters.
- Women are only allowed to participate in this study if they have been postmenopausal for at least one year or have been surgically sterilized.
- To determine if you are suitable to participate in this study, you will undergo a medical screening.
You will receive a gross compensation of € 2.049,- for participation in Group 13.
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
For group 13, the MAD part (multiple ascending dose part) the study consists of 1 period during which you will stay in our research facility in Groningen (location Martini) for 17 days (16 nights).
Please note: You have to be available for all dates for the group of choice to be able to participate in this study. These are the currently planned dates; however, these may be subject to change.
Type of study
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 (this is called pharmacokinetics [PK]). Further, the effect of food on the pharmacokinetics will be investigated (FE part only). In addition, the effect of the compound on certain proteins in your blood will be investigated (this is called pharmacodynamics) (all study parts).
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, a single ascending dose part with an integrated food effect part (SAD/FE part), a multiple ascending dose part (MAD part) and patient part).
This document contains the information about the MAD part. The actual study consists of 1 period during which you will stay in the clinical research center in Groningen (location UMCG) for 17 days (16 nights).
Before the start of the study you will visit the medical screening center in Groningen. You will receive the study drug or placebo once daily in the form of oral capsules. Blood samples will be taken and urine will be collected regularly during the study.
Risks and medical supervision
The new study drug may eventually be used for the treatment of inflammatory bowel disease (IBD) and rheumatoid arthritis (RA), both inflammatory diseases. IBD is a chronic inflammatory disorder of the gastrointestinal tract of which 2 main forms can be distinguished, namely Crohn’s disease (CD) and ulcerative colitis (UC). Rheumatoid arthritis is a long-lasting auto-immune disorder that primarily affects the joints. The study compound that will be researched in this study inhibits a protein that is involved in abnormal immune responses seen in this type of conditions.
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 or female of non-child bearing potential between 18 and 55 years old. Your Body Mass Index (BMI) is between 18 and 32 kg/m2. The BMI shows the relation between body weight in kilograms and length in meters. You can only take part in the study if you do not smoke. Women must be surgically sterile or post-menopausal.
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) during the study is not allowed.
Also before the study there will be restrictions for these products. Use of decaffeinated coffee and (herbal) 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 four weeks before the start of the study.
17 days stay
- 10 okt 2017 up to and including 26 okt 2017