Learn more about this research?
- You do not smoke.
- Your Body Mass Index (BMI) is between 18 and 32 kg/m2. The BMI reflects the relation between your body weight in kilograms and your height in meters.
- To determine if you are eligible to participate in this study, you will undergo a medical screening.
You will receive a gross compensation of € 2.314,- for full participation in Group 1.
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, irrespective of the method of transportation.
Period of stay and research
The study consists of 1 period were you will stay for 20 days (19 nights) in our research facility in Groningen (location UMCG).
Please note: You have to be available for the entire period to participate in this study. These are the currently planned dates; however, these may be subject to change. If the dates do change you will be notified as soon as possible.
Information sheet PRA-176761
Type of study
The purpose of this study is to investigate the influence of the study medication on the absorption, distribution, and elimination (this is called pharmacokinetics) of Methotrexate from the body. The study medication has been administered to humans before. Methotrexate is not a new compound, it is already available on the market in several dosages and formulations. It will also be investigated whether Methotrexate given without and with the study medication is safe. This study is not intended to improve your health, but is necessary for the further development of this study medication.
In autoimmune diseases the immune system does not only react to foreign substances, as it should, but also to parts of the body. This results in inflammatory reactions in the joints (RA), skin (psoriasis), or the bowel. The study medication blocks an enzyme (tyrosine kinase 2) which has a role in the immune response and should decrease the immune response to parts of the body. Methotrexate has been on the market for more than 50 years as a drug for the treatment of RA, psoriasis, and some types of cancer. To prevent potential side effects of Methotrexate as much as possible, leucovorin (calcium folinate) will be given 24 hours after the administration of Methotrexate. Leucovorin is a drug used to block part of the activity of Methotrexate thus reducing the risk for side effects.
The study will only take place after it has been approved by the Independent Ethics Committee.
Setup and duration of the study
The study consists of 1 period were you will stay for 20 days (19 nights) in our research facility in Groningen (location UMCG). The study medication will be given as oral capsules, Methotrexate as tablets and Leucovorin as capsules. Before the start of the study you will visit the medical screening centre. Blood samples will be taken regularly during the study.
Risks and medical supervision
All drugs have the potential to cause adverse events. You should be aware that unknown adverse effects may occur during the study. The study medication is a so-called kinase inhibitor. Acne is a side-effect of many drugs with a similar mechanism of action. The same is true for the study medication. Acne can occur from the second day of treatment onwards on typical places like the face and chest, but other parts of the body may also be affected. In general, the skin abnormalities resolve spontaneously when the drug is discontinued. In most cases the acne is treated with a cream. Other types of skin rashes, including urticaria, were occasionally observed.
In general, tolerability of Methotrexate as a single dose in healthy volunteers is excellent. As a precaution against possible side effects, you will get a dose of Leucovorin 24 hours after the administration of Methotrexate. Leucovorin is used as an antidote, a compound countering the side effects of other compounds, like for Methotrexate. Sometimes, in less than 1 in 100 people, Leucovorin can cause fever.
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 50 years old. Your Body Mass Index (BMI) is between 18.0 and 32.0 kg/m2 (the BMI reflects the relation between your body weight in kilograms and your height in meters). You can only take part in the study if you do not smoke.
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 and during each period there will be restrictions for these products. Use of decaffeinated coffee and (herbal) teas without caffeine (also mentioned theine) is allowed. Before you are allowed to take part in the study, you will be medically screened. The screening will take place within four weeks before the start of the study.
- Period of stay
- 20 days
- 0 times
- € 2.314,-
Group 1a€ 2.314,-
20 days stay
- 12 Apr 2018 up to and including 1 May 2018