Group 1
- 24 November up to and including 10 Dezember
Period(s) of stay (17 days)
- 24 November up to and including 10 Dezember
- €4033,-
Compensation
- €4033,-
10 or 16 December 2024
Follow up
10 or 16 December 2024
Find out if you qualify for this trial
- You are a healthy male or female
- You are between 18 and 55 years old
- You weigh more than 60 kg
- Your Body Mass Index (BMI) is between 18 and 29.9 kg/m2
Good to know about this trial
- The study compound has been administered to humans before.
- The study compound will be administered twice as a tablet (by mouth), together with an intravenous infusion (administration directly into a blood vessel) during the first administration. From day 8, you will also receive an approved medicine which is already available on the market (atazanavir), once daily for 9 days as a capsule (by mouth).
- As a light smoker (maximum of 5 sigarettes per day) you can particpate in this trial.
Study groups
Register without obligation for the group of your preference
The research physician about this research
Additional information
In this clinical trial, we investigate how the study compound is processed and eliminated by the body when it is taken alone or in combination with an approved medicine which is already available on the market (atazanavir). Atazanavir is being used for the treatment of human immunodeficiency virus (HIV). In addition, it is investigated how well the study compound is tolerated when it is used by healthy participants. Furthermore, it will also be investigated how well the study compound is absorbed by the body when given by mouth compared to an intravenous administration (administration directly into a blood vessel).
Who can participate?
Target group
- You are a healthy male or female.
- You are at least 18 and at most 55 years old.
- Your weight is at least 60 kg and your Body Mass Index (BMI) is at least 18.0 and at most 29.9 kg/m2.
- Both non-smokers and light smokers or occasional smokers are allowed to participate (maximum of 5 cigarettes per day) 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 the 3 months prior to the first study compound administration in 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 female you can only participate if you are not pregnant, not breast feeding and meet one of the following conditions:
- You have passed the menopause (no periods for at least 12 months);
- You have been sterilized.
- 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 highly effective contraceptive method used by 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 will receive a gross compensation of € 4033 for participation in this trial.
Travel expenses will 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 in-house period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 17 days (16 nights). The follow-up visit will take place 8 to 12 days after the last administration of the study compound.
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 bijwerkingen. 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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Als je meedoet aan geneesmiddelenonderzoek, moet je een paar keer per dag iets doen voor het onderzoek, zoals een test of gezondheidscheck. Maar je hebt ook veel tijd voor jezelf! In het onderzoekscentrum vind je van alles om die tijd mee in te vullen. Er zijn bijvoorbeeld computers, Playstations, tv’s met Netflix, maar ook een tafeltennistafel, pooltafel en een dartbord. En natuurlijk is er wifi, dus neem gerust je eigen laptop of tablet mee. Sommige deelnemers gaan voor hun werk of studie aan de slag. Maar je kunt natuurlijk ook een paar dagen lekker ontspannen.
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Hoeveel geld je krijgt voor jouw deelname aan een geneesmiddelenonderzoek, wordt bepaald door de duur van het onderzoek. Hoe langer het onderzoek duurt, hoe hoger de vergoeding. Maar er zijn meer factoren die de hoogte van de vergoeding bepalen, zoals speciale medische handelingen.