Lebererkrankungen

Lebererkrankungen

Three-part clinical trial of a new compound that is in development for the potential treatment of liver disorders

The research physician about this research

In this clinical trial we will investigate how safe the study compound is and how well it is tolerated when it is used by healthy participants. The effect of food on the study compound will be investigated in part C of this clinical trial.

Important information about this study

• A part of the compensation will be paid during the study
• You will receive the study drug or placebo as a capsule
• Note: you cannot participate if you smoke
• This clinical trial started on July 6, 2021 and 19 groups have already been completed!

Who can participate?

• You are a healthy male or female
• You are between 18 and 55 years old
• Your Body Mass Index (BMI) is between 18.0 and 30.0 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 2 months prior to this clinical trial (counting from the follow-up visit).
• 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 male you can only participate if you meet one of the following conditions:

• You are using a condom;
• You have been sterilized or your female partner has been sterilized or is postmenopausal and you use a condom;
• You remain abstinent (not sexually active) if in accordance with your lifestyle .

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 and your male partner uses a condom;
• You have passed the menopause (no period for at least 12 months);
• You have been sterilized at least 6 months prior to the first administration.
• You are not heterosexually active in accordance with your lifestyle.

Compensation

• For participation in one of the groups of part A of the trial, you will receive a gross compensation of € 1.392,-.
• For participation in one of the groups of part B of the trial, you will receive a gross compensation of € 3.361,-.
• For participation in part C you will receive a gross compensation of € 2.924,-.
• Travel 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 round trip, regardless of the mode of transportation.

Period of stays and research

The trial consists of 3 parts: part A, part B and part C. You can only participate in one part of this clinical trial.

• Part A consists of 1 period during which you will stay in the research facility in Groningen for 6 days (5 nights), followed by 1 outpatient visit. The follow-up visit will take place 7 days after your last outpatient visit.
• Part B consists of 1 period during which you will stay in the research facility in Groningen for 19 days (18 nights), followed by 1 outpatient visit. The follow-up visit will take place 7 days after your last outpatient visit.
• Part C consists of 2 periods during which you will stay each period in the research facility in Groningen for 6 days (5 nights), and each period is followed by 1 outpatient visit. The follow-up visit will take place 7 days after your last outpatient visit.

PLEASE NOTE: You must be available for all dates to be able to participate in this trial. The current dates of the trial will be published on our website. These are the currently planned dates; however, these may be subject to change.