Bacterial infection

Bakterielle Infektion

Clinical trial of a new compound that is being developed for the treatment of Clostridium difficile colitis (bacterial infection in the bowel)

The research physician about this research

In this study the safety and tolerability of the study compound is investigated when administered to healthy volunteers. The trial consists of 2 parts: part A and part B. You can participate in one part of the trial.

Für Deutschland: Bitte beachten Sie: Die Arzneimittelstudien finden im niederländischen Groningen statt. Sie müssen Englisch oder Niederländisch sprechen, verstehen und lesen können, um an einer Studie teilnehmen zu können.

Important information about this study

• Only 1 short period of stay. Easy to combine with your studies or work.
• Single administration of study drug as a capsule
• Note: For this study we are looking for healthy participants between 18 and 65 years old. Except for groups A7a and A7b. For this we are looking for healthy participants aged 66 and older.

Who can participate?

• You are a healthy male or female
• You are 18 years or older (note: age differs per group)
• Your body weight is at least 50 kg and your Body Mass Index (BMI) is between 18.0 and 32.0 kg/m2.
• Only non-smokers are allowed to participate in this clinical trial.

Note: 

• You cannot participate in the trial if you have participated in another clinical trial in the 28 days prior to this clinical trial (counting from the follow-up visit).
• For this trial, you cannot have received a COVID-19 vaccine (including booster vaccines) within 14 days prior to the start and during this trial.
• 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 meet one of the following conditions:

• 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 only have sexual contact with females;
• 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;
• You have been sterilized or your female partner is sterilized or postmenopausal;
• You only have sexual contact with men;
• You are not sexually active according to your lifestyle.

Compensation

• You will receive a gross compensation of € 1250 for participation in one of the groups of part A.
• For participation in one of the groups of part B of the trial, you will receive a gross compensation of € 3720. 

Travelling expenses will be reimbursed based on the distance traveled (€ 0,21 net per kilometer) with a minimum of € 12,- and a maximum of € 177,- (840 kilometers) per round trip, regardless of the mode of transportation.

Period of stays and research

The trial consists of 2 parts: part A and part B.

• Part A consists  of 1 period  during which you will stay in the research facility in Groningen for 5 days (4 nights). The follow-up visit will take place around 5 days after your departure from the research facility.
• Part B consists  of 1 period  during which you will stay in the research facility in Groningen for 18 days (17 nights). The follow-up visit will take place around 6 days after your departure from the research facility.

Particularities

Curious about what to expect when participating in a holter-ECG study? Then watch the video below!