Group 1a
- 22 up to and including 29 July
Period(s) of stay (8 days)
- 22 up to and including 29 July
- €2080,-
Compensation
- €2080,-
By appointment on 31st of July & 2nd of August 2024
Follow up
By appointment on 31st of July & 2nd of August 2024
Find out if you qualify for this trial
- You are a healthy male or female
- You are between 18 and 70 years old
- Your Body Mass Index (BMI) is between 18 and 32 kg/m2
Good to know about this trial
- The study compound has been administered to people before
- The maximum age to participate is 70 years old
- The research takes place in Groningen and Utrecht
Study groups
Register without obligation for the group of your preference
THE RESEARCH PHYSICIAN ABOUT THIS RESEARCH
Additional information
- The study compound is a new compound that may potentially be used for the treatment of amyotrophic lateral sclerosis (ALS). ALS is a rare disease where nerve cells in the brain and spinal cord that are responsible for movement become damaged and die. This results in loss of coordination, muscle mass, muscle strength, ability to speak, swallowing function, and eventually respiratory function. ALS gets worse over time and current treatments only bring about a small increase in lifespan. There is no cure.
- The study compound is being developed as a potential treatment for ALS as lab tests have shown that it can reduce the overactivation of cells. Overactivation in nerve cells in the brain and spinal cord is shown to correlate with a shortened lifespan in people with ALS.
- In this study we look at how safe the new study compound is and how well it is tolerated when it is used by healthy participants. We also investigate how quickly and to what extent the study compound is absorbed, transported, and eliminated from the body. The study compound has been administered to humans before.
- In this study, the study compound will be tested at different doses.
- The effects of the study compound are compared to the effects of a placebo (a compound without any active ingredient). It is determined by chance whether you get the study compound or the placebo.
- During your participation, you will receive the study compound as a liquid that you will take in by mouth three times daily on days 1 through 4 and a single time on day 5.
WHO CAN PARTICIPATE?
Target group
- You are a healthy male or female.
- You are at least 18 and at most 70 years old.
- Your Body Mass Index (BMI) is between 18.0 and 32.0 kg/m2.
- Both non-smokers and light smokers (maximum of 5 cigarettes per day) are allowed to participate in this clinical trial. During your stay in our research facility you are not allowed to smoke.
Note:
- You cannot participate in the trial if you have participated in another clinical trial in one month prior to the first compound administration in this clinical trial (counting from the follow-up visit of the previous 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 are not pregnant, not breast feeding and meet one of the following conditions:
- You are using hormonal contraception (for example the contraceptive pill or intra-uterine device containing hormones);
- You are using a copper intra-uterine device;
- You have passed the menopause (no periods for at least 12 months);
- You have been sterilized or your male partner has been sterilized;
- You are not sexually active according to your lifestyle;
- You are only sexually active with a partner of the same sex.
- As a male you can only participate if you meet one of the following conditions:
- You are using a condom with your female partner;
- You have been sterilized or your female partner is sterilized or has passed the menopause (no periods for at least 12 months);
- You are not sexually active according to your lifestyle;
- You are only sexually active with a partner of the same sex.
WHAT IS THE COMPENSATION FOR THIS RESEARCH?
Compensation
You may receive a gross compensation of up to € 2080 for full participation in in this trial. The compensation will be paid out after completion of the study.
Travel expenses will also be reimbursed based on the distance traveled (€ 0.21 net per kilometer) with a minimum of € 13 and a maximum of € 176,40 (840 kilometers) per round trip, regardless of the mode of transportation.
HOW LONG DOES THIS RESEARCH TAKE?
Period of stay and research
The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 8 days (7 nights). The follow-up visit will take place 2 to 4 days after your departure from the research facility.
Note: You must be available for all dates to be able to participate in this clinical trial.
Veelgestelde vragen
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Je mag maximaal 4 keer per jaar deelnemen aan een onderzoek. Tussen twee onderzoeken moeten minstens 30 dagen zitten. Voor sommige onderzoeken geldt een langere wachttijd.
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Je kunt tijdens het onderzoek last krijgen van milde klachten als hoofdpijn of misselijkheid. Dat kan door het geneesmiddel komen. Maar het kan ook komen doordat je voor het onderzoek bijvoorbeeld nuchter moet blijven. Die bijwerkingen zijn vervelend, maar gelukkig niet gevaarlijk.
Voordat een geneesmiddel op mensen mag worden getest, is het al uitgebreid onderzocht in een laboratorium. Daardoor kunnen we goed voorspellen welke bijwerkingen je eventueel kunt krijgen en kunnen we je daarop voorbereiden. Het komt dus bijna nooit voor dat deelnemers last krijgen van onverwachte bijwerkingen. Een allergische reactie op het middel komt gemiddeld bijvoorbeeld één keer per jaar voor.
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Je deelname aan geneesmiddelenonderzoek is altijd vrijwillig. Je mag dus op elk moment besluiten om te stoppen. Soms ben je genoodzaakt om te stoppen. Bijvoorbeeld vanwege familieomstandigheden, of als de arts besluit dat dat voor jouw gezondheid beter is. Als je stopt, bekijken we op welk deel van de vergoeding je recht hebt. Wel zo eerlijk!
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Als je meedoet aan een onderzoek waarvoor je langer dan 10 dagen in het onderzoekscentrum verblijft, is het soms mogelijk om (in overleg) bezoek te ontvangen.