Learn more about this research?
- You do not smoke.
- Your Body Mass Index (BMI) is between 18 and 30 kg/m2. The BMI reflects the relation between your body weight in kilograms and your height in meters.
- As a male you are only allowed to participate in this study if you:
- use a condom and your female partner uses an intrauterine device;
- or use a condom and your female partner uses an additional hormonal contraceptive (e.g. the pill);
- or are vasectomized at least 6 months before the start of the study;
- or are true abstinent during the study.
- As a female you are only allowed to participate in this study if you:
- use a intrauterine device or hormonal contraceptives (e.g. the pill) and your male partner uses a condom;
- or are true abstinent during the study;
- or your male partner has been vasectomized at least 6 months before the start of the study;
- or you are surgically sterilized or have had a tubal ligation at least 6 months before the start of the study;
- or you are postmenopausal for at least 12 months (without menstrual periods).
- To determine if you are eligible to participate in this study, you will undergo a medical screening.
You will receive a gross compensation of € 1.327,- for full participation in one of the groups mentioned above.
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
For all groups the study consists of 1 period where you will stay for 10 days (9 nights) in our research center in Groningen, followed by 2 short visits to our research center.
Please note: You have to be available for the entire period for the group of choice to be able to participate in this study. The above dates 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-180541
Type of study
Soon a research study will start at PRA with a new drug that may eventually be used for the treatment of fungal infections.
The purpose of the study is to investigate how safe the study medication is and how well it is tolerated. It will also be investigated how quickly and to what extent the study compound is absorbed and eliminated from the body. The effects of the study compound will be compared to the effects of a placebo. A placebo is a medicine without any active ingredient. The study compound has been administered to humans before.
This study is not intended to improve your health, but is necessary for the further development of this study medication. The study will only take place after it has been approved by the Independent Ethics Committee.
Setup and duration of the study
For all groups the study consists of 1 period where you will stay for 10 days (9 nights) in our research center in Groningen (location Martini), followed by 2 short visits to our research center.
On Day 1 you will receive the study compound twice via an intravenous infusion, once after breakfast and once after dinner. From day 2 up to day 7 you will receive 1 intravenous infusion each day after breakfast. You will receive the study medication administered as a 3 hour infusion. 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. The study compound has been administered to healthy volunteers in two previous medical-scientific studies. The study compound were administered by an intravenous infusion, orally as a tablet and orally as a liquid. Thus far the study compound has been well tolerated. Across both studies, the most frequently reported side effects were nausea, headache, vomiting, fatigue and dizziness.
You should be aware that the aforementioned adverse effects and possibly other, still unknown, adverse effects may occur during the study.
You will be under strict medical supervision during the study. 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 or female between 18 and 55 years old. Your Body Mass Index (BMI) is between 18.0 and 30.0 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. As a female volunteer you are only allowed to participate in this study if you use a medically acceptable method of contraception (for example hormonal contraceptives or a intrauterine device) or if you are postmenopausal for at least one year or if you are surgically sterilized. Women who are pregnant or breastfeeding are not eligible for participation.
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 called 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
- 10 days stay
- 2 times
- € 1.327,-
Group 2b€ 1.327,-
10 days stay
- 1 Nov 2018 up to and including 10 Nov 2018
- 12 Nov 2018
- 15 Nov 2018
Group 3a€ 1.327,-
10 days stay
- 19 Nov 2018 up to and including 28 Nov 2018
- 30 Nov 2018
- 3 Dec 2018
Group 3b€ 1.327,-
10 days stay
- 29 Nov 2018 up to and including 8 Dec 2018
- 10 Dec 2018
- 13 Dec 2018
Group 1c€ 1.327,-
10 days stay
- 24 Sep 2018 up to and including 3 Oct 2018
- 5 Oct 2018
- 8 Oct 2018
Group 2a€ 1.327,-
10 days stay
- 22 Oct 2018 up to and including 31 Oct 2018
- 2 Nov 2018
- 5 Nov 2018