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- You do not smoke or are a light smoker
- Your Body Mass Index (BMI) is between 18.5 and 29.9 kg/m2 and your body weight is between 50kg and 100 kg. The BMI shows the relation between body weight in kilograms and height in meters.
- For women; If you are heterosexually active, you have to use one of the following highly effective methods of contraception:
- Vasectomized male partner
- Intrauterine device with or without hormones
- Use of continuous hormonal contraception, combined with the use of a condom by your male partner. The condom should then be used together with a spermicide called Contragel Green which can be provided by PRA.
- Bilateral tube occlusion
- You are not sexually active (with a man).
- For men; If you are heterosexually active, you have to use one of the following highly effective methods of contraception:
- Female partner using a highly effective method of contraception for women as listed above
- Female partner using continuous hormonal contraception or has an intrauterine device
- You are not sexually active (with a woman).
- To determine if you are suitable to participate in this study, you will undergo a medical screening.
You will receive a gross compensation of € 672,- for participation in one of the A-groups of this study.
You will receive a gross compensation of €1440,- for participation in one of the B-groups.
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, regardless of the mode of transportation.
Period of stay and research
For Part A (A-groups), the study, consists of 1 period in which you will stay in our research facility in Groningen (location Martini) for 5 days (4 nights), followed by a short visit.
For Part B (B-groups), the study, consists of 1 period in which you will stay in our research facility in Groningen (location Martini) for 11 days (10 nights), followed by a short visit.
Please note: You have to be available for all dates for the group of choice to be able to participate in this study. These are the currently planned dates; however, these may be subject to change.
Information sheet PRA-176341
Type of study
Iron is important for several functions in the body. Among other things, it is necessary for the production of haemoglobin, the protein that transports oxygen in in red blood cells. Iron is also necessary for adequate functioning of your immune system and nervous system. However, too much iron in the body can cause damage. In certain diseases, too much iron may be absorbed or, may end up in the blood stream because of dysregulation. This will result in iron being stored in organs, which will eventually lead to tissue damage and organ failure.
The purpose of this study is to investigate how safe the new compound is when it is administered to healthy subjects. The new compound has not been administered to humans before. It has been previously tested in the laboratory and on animals.
It will also be investigated how quickly and to what extent the compound is absorbed and eliminated from the body (this is called pharmacokinetics). In addition, the effect of the compound on the body will be investigated. In addition, the effect of the compound on several iron-related markers in your blood will be investigated (this is called pharmacodynamics).
The effects of the compound will be compared to the effects of a placebo. A placebo is a medicine without any active ingredient. It is a ‘fake’ medicine.
This study is not intended to improve your health, but is necessary for the further development of the new study drug.
The study will only take place after it has been approved by the Independent Ethics Committee.
Setup and duration of the study
This study contains 2 parts, Part A and B.
For Part A, the study, consists of 1 period in which you will receive the compound or placebo once and it will be given as capsules. A placebo is a medicine without any active ingredient. It is a ‘fake’ medicine. Whether you will receive the compound or placebo will be determined by chance; we call this ‘the study is randomized’. Per group, 6 volunteers will receive the compound and 2 volunteers will receive placebo, meaning that you will have 75% chance to receive the compound and 25% chance to receive placebo. Neither you, nor the investigator knows if the compound or placebo will be dosed; we call this ‘the study is blinded’. However, if it is important for your health, for example in case of a serious adverse event, this information can be looked up during the study.
For participation in Part A, you will stay in our research facility in Groningen (location Martini) for 5 days (4 nights), followed by a short visit.
For Part B, the study, consists of 1 period in which you will receive the compound or placebo once a day for seven consecutive days. Depending of the results of Part A, it may be decided to adjust the dosing to twice daily in 1 or more groups in Part B. The compound will be given as capsules. During this period, you will stay in our research facility in Groningen (location Martini) for 11 days (10 nights), followed by a short visit.
Before the start of the study, you will undergo a medical screening in the Medical Screening Center Groningen (location Martini). Blood samples will be taken regularly during the study.
Risks and medical supervision
All potential drugs cause adverse effects; the extent to which this occurs differs.
As the compound will be administered to human for the first time in this study, side effects of the compound in human have not been reported to date. However, the compound has been studied in the laboratory and in animals. In these studies, at high repeated doses the compound showed an influence on certain heart parameters including sporadic heart rate increases, however there were no irregular heartbeats or other severe abnormalities observed. With repeated dosing in dogs at very high doses, that are much higher than the doses planned to be administered in the studies in healthy subjects vomiting, involuntary shaking of a body part and decreased activity were observed. All symptoms appeared gradually after dosing and were completely normalized by the end of the study.
You should be aware that possibly other, still unknown adverse effects may occur during the study. However, with the doses used in this study serious adverse effects are unlikely to occur.
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.
- Period of stay
- 11 days
- 1 times
- € 1.440,-
Group B2€ 1.440,-
11 days stay
- 20 Aug 2018 up to and including 30 Aug 2018
- 2 Sep 2018
Group B3€ 1.440,-
11 days stay
- 11 Sep 2018 up to and including 21 Sep 2018
- 24 Sep 2018
Group B4€ 1.440,-
11 days stay
- 2 Oct 2018 up to and including 12 Oct 2018
- 15 Oct 2018