Study of a compound that is being developed for the treatment of chronic pain
- You are a woman and between 18 and 65 years old.
- Your Body Mass Index (BMI) is between 18 and 32 kg/m2. The BMI shows the relation between body weight in kilograms and length in meters.
- Both non-smokers and smokers or social smokers are allowed to participate in this study; however, during your stay in the research facility, smoking is not allowed.
- Women are only allowed to participate in this study if they are using double contraception, have been postmenopausal for at least one year or have been surgically sterilized.
- To determine if you are suitable to participate in this study, you will undergo a medical screening.
For group A7 of part A you will receive a gross compensation of €1,933,-.
For participation in group B1 or B1a you will receive a gross compensation of €2,058.-. For participation in group B2 you will receive a gross compensation of €2.421.- and for group B3 you will receive a gross compensation of €2.542,-.
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
Group A7 of part A consists of 3 periods of 5 days (4 nights). There are 3 and 2 days between the periods respectively.
Group B2 consists of 1 period during which you will stay in our research facility in Groningen for 19 days (18 nights) and group B3 consists of 1 period during which you will stay in our research facility in Groningen for 20 days (19 nights).
For all groups there is a follow up visit between 7 and 11 days after the last dosing. For all groups there is a follow up visit between 7 and 11 days after the last dosing.
Please note: You have to be available for all dates for the group of choice to be able to participate in this study. The actual dates will be published on our website. These are the currently planned dates; however, these may be subject to change.
Type of study
Soon a research study will start at PRA with a study drug that may eventually be used for the treatment of chronic pain. The purpose of the study is to investigate to what extent the study medication is safe and tolerated. It will also be investigated how quickly and to what extent the study medication is absorbed and eliminated from the body. In addition, the effect of a high fat breakfast on the absorption will be investigated in groups 3 and 4 of part A.
The study drug is not registered as a drug and has not been given to humans before. The study will only take place after it has been approved by the Independent Ethics Committee.
Setup and duration of the study
The actual study will consist of 2 parts: part A & part B.
Part A consists of 1 period during which you will stay in the clinical research center in Groningen for 4 days (3 nights). Group 3 of part A consists of 2 periods* of 4 days (3 nights) with 24 days in between. Group 4 of part A also consists of 2 periods of 4 days (3 nights), but then with 52 days in between.
Part B consists of 1 period during which you will stay 16 days (15 nights) in our clinical research center in Groningen. Follow up visit will be conducted between 7 and 11 days after the last dosing for all parts. Before the start of the study you will visit the medical screening centre in Groningen.
*Group 3 only consists of 2 periods for women. Male participants will only stay the first period, similar as the other groups in part A. The reimbursement will also be the same as the other groups.
In part A you will receive the study drug or placebo once in the form of one or more capsules, pending on the dose level. In group 3 and 4 of part A you will receive the study drug once every period in the form of a capsule. Once while fasted and once after a high fat breakfast. In part B you will receive the study drug or placebo once every day for 14 days in the form of a capsule. Blood samples will be taken and urine (Part A only) will be collected regularly during the study.
Working mechanism and risks
The study drug will inhibit a specific protein. This protein is present on nerve cells that transmit painful stimuli. In this way, the study drug may eventually be used for the treatment of chronic pain. The study drug will be administered to humans for the first time during this study. However, the study drug has been studied extensively in the laboratory and in animals. In male rats when the study drug was administered for four weeks at high doses, negative effects were observed on the testes. The dose levels in the current study will be significantly lower and therefore these side effects are not expected. However, to avoid any unnecessary risks, male subjects can only participate in the first 3 single and low dose groups. In female rats and monkeys (both sexes), no toxic effects were observed. Please keep in mind that the study drug may have side effects that are still unknown. 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 65 years old. You can only take part in the study if you do not smoke or are a light smoker. Men can only participate in the first 3 groups of part A. Women must use acceptable methods of contraception (birth control), be post-menopausal for at least 12 months or be surgically sterilized for at least 6 months in order to participate in this study.
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. Before the study there will be restrictions for these products as well. Use of decaffeinated coffee and (herbal) teas without caffeine is allowed. Before you are allowed to take part in the study, you will be medically screened; this screening will take place within four weeks before the start of the study.
You will receive maximum compensation of €562.- gross for participation in one of the groups of part A. For group 3 of part A you will receive maximum compensation of €1,354.- gross. For group 4 of part A you will receive maximum compensation of €1,802.-.
For participation in one of the groups of part B you will receive a maximum compensation of €2,058.- gross.
Traveling expenses will be reimbursed on the basis of traveled kilometers (€ 0.19 net per kilometer) with a minimum of € 12.- per return, and with a maximum of € 160.- (840 kilometers) per return, irrespective of the method of transport.
Sign up for one of the following study groups
20 days stay
- 4 Feb 2020 up to and including 23 Feb 2020
- by appointment
3× 5 days stay
- 12 Feb 2020 up to and including 16 Feb 2020
- 20 Feb 2020 up to and including 24 Feb 2020
- 27 Feb 2020 up to and including 2 Mar 2020
- by appointment
Groep A4 FemaleFull
2× 4 days stay
- 29 Aug 2019 up to and including 1 Sep 2019
- 24 Oct 2019 up to and including 27 Oct 2019
Group A5 FemaleFull
4 days stay
- 15 Sep 2019 up to and including 18 Sep 2019
Groep A6 WomenFull
4 days stay
- 8 Oct 2019 up to and including 11 Oct 2019
Group B1 FemaleFull
16 days stay
- 7 Nov 2019 up to and including 22 Nov 2019
16 days stay
- 5 Dec 2019 up to and including 20 Dec 2019
- by appointment
19 days stay
- 7 Jan 2020 up to and including 25 Jan 2020
- by appointment