Die Studie

Clinical trial of a new compound that is being developed for the treatment of asthma and refractory chronic cough.

  • During the trial your heart rhythm will be continuously monitored during certain moments. You will be given electrodes (small, plastic patches) on your chest and abdomen that are connected to a portable device.
  • For certain groups, the first entry in the research center will be preceded by one short visit. During this short visit, an itch/pain test (which is a part of the medical screening) will be conducted. You will be informed in advance whether this short visit is necessary.
  • During the itch/pain test a small amount of mustard oil will be placed on the skin of the forearm, this will irritate the skin. Thereafter it will be measured to what extent the blood flow rises in reaction to the mustard oil.
  • The itch/pain test will (if applicable for the group) be repeated during your stay in the research facility (part 1: one time, part 2: up to three times, part 3: two times).

Who can participate?

  • Your are a healthy male or female.
  • You are between 18 - 75 years old.
  • Your Body Mass Index (BMI) is between 18.0 and 30.0 kg/m2
  • Only non-smokers are allowed to participate in this clinical trial.

Note:

  • You cannot participate in the trial if you have participated in another clinical trial in the 28 days prior to this clinical trial (counting from the last administration)
  • 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 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 postmenopausal;
  • You are not heterosexually active according to your lifestyle.

As a female you can only participate if you are not pregnant and not breastfeeding and meet one of the following conditions:

  • You are using adequate contraception (for example the contraceptive pill or intrauterine device containing hormones);
  • You have passed the menopause (no period for at least 12 months)
  • You have been sterilized or your male partner has been sterilized;
  • You are not heterosexually active according to your lifestyle.

Zeitraum

The trial consists of 3 parts: part 1, part 2 and part 3. You can participate in one part of the trial. Part 1 consists of 1 period during which you will stay in the research facility in Groningen for 6 days (5 nights), followed by 3 short visits. The follow-up visit will take place during your last short visit.

Part 2 consists of 2 periods during which you will stay for 13 days (12 nights) in the first period and for 5 days (4 nights) in the second period in our research facility in Groningen. Each period is followed by 3 short visits. The follow-up visit will take place during  the last short visit of period 2.

Part 3 consists of 1 period during which you will stay in the research facility in Groningen for 13 days (12 nights), followed by 2 short visits. The follow-up visit will take place during your last short visit.

Note: You must be available for all dates to be able to participate in this study. These are the currently planned dates; however, these may be subject to change.

Aufwandsentschädigung

  • You will receive a gross compensation of €1809* / €1517 for participation in one of the groups of part 1.
  • For participation in one of the groups of part 2, you will receive a gross compensation of €4567* / €4033.
  • For participation in one of the groups of part 3 you will receive a gross compensation of €2895*/ €2482.

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 round trip, regardless of the mode of transportation.

*Group with itch/pain test.