PRA-170321 Auto-immune diseases € 2.918,-

Full

Description

Study of a new compound that is being developed for the treatment of autoimmune diseases such as Ulcerative Colitis (an inflammatory disease of the colon)

Requested participants

  • M/F, healthy, 18 - 55 years old
  • Non-smokers only

Duration and visits

  • 18 days stay

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Research details

Particulars

  • You do not smoke
  • Your body weight must be between 50 and 100 kg and your Body Mass Index (BMI) is between 18.5 and 29.9 kg/m2. The BMI shows the relation between body weight in kilograms and length in meters.
  • Women are only allowed to participate in this study if they are using sufficient contraception (hormonal contraceptives or an intrauterine device combined with a barrier method, such as a condom) or if they have been postmenopausal for at least one year or if they have been surgically sterilized.
  • To determine if you are suitable to participate in this study, you will undergo a medical screening. This screening consists of two visits: first you will visit our medical screening facility in Groningen (location Martini) for the medical screening. Once you are suitable for participation at that point, you will visit the Martini Hospital in Groningen on a separate occasion for an eye examination.
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Compensation

You will receive a gross compensation of € 2.918,- for participation in one of the groups of this study.

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

The study consists of 1 period during which you will stay in our research facility in Groningen (location Martini) for 18 days (17 nights).

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-170321

Type of study

The purpose of the study is to investigate the effect of the study drug on the values of specific ECG parameters. It will also be investigated to what extent the study drug is safe, tolerated, and how quickly and to what extent it is absorbed and eliminated from the body. The study drug is not registered as a drug, but has been given to humans before in previous studies.

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 1 period, during which you will stay in the clinical research center in Groningen (location Martini) for 18 days (17 nights). Before the start of the study and after the study you will visit the medical screening center in Groningen (location Martini). In addition, you will visit the Martini Hospital in Groningen before the start of the study for an eye examination (OCT: Optical Coherence Tomography, a scan of the retina).

During the actual study you will receive multiple oral doses of study drug for 14 days or a single dose of moxifloxacin either on Day 1 or on Day 15. In all treatments you will receive placebo matching the study drug and/or placebo matching moxifloxacin. A placebo is the same formulation without the active ingredient. Whether you will receive the study drug or moxifloxacin on Day 1 or Day 15 will be determined by chance. The study drug (and matching placebo) will be given as tablets. Moxifloxacin (and matching placebo) will be given as oral capsules.

Blood samples will be taken regularly during the study and lung function tests will be carried out on certain time points during the study. In addition, ECG’s will be made regularly and on Day 1 and 8 your heart rhythm will be monitored continuously (telemetry). On Days -1, 1, 7, 12, 14 and 15 you will be connected to a special device (holter ECG) that will continuously record your ECGs from 1 hour before until 24 hours after administration of the study drug.sten worden gedaan. Bovendien worden er regelmatig ECG’s gemaakt en je hartritme zal op Dag 1 en 8 continu worden bewaakt (telemetrie). Op Dag -1, 1, 7, 12, 14 en 15 word je aangesloten op een speciaal apparaat (holter ECG) dat continu je ECG’s registreert van 1 uur voor de toediening van het onderzoeksmiddel tot 24 uur daarna.

Risks and medical supervision

The study drug is a new investigational compound that may eventually be used for the treatment of autoimmune diseases such as ulcerative colitis (an inflammatory disease of the colon). The study drug is able to bind to a specific protein on the cell surface of a certain kind of white blood cells. This kind of cells are involved in the inflammatory processes of autoimmune diseases. By binding to this protein on the cell surface, the study drug prevents the white blood cells from reaching sites of inflammation. It is believed that this will help to treat different inflammatory diseases.

Moxifloxacin is used as a control during this study. It is on the market as an antibiotic and has been available in the European Union for almost 10 years.

All potential drugs cause adverse effects; the extent to which this occurs differs.

Study drug:
To date at least 80 people have taken the study drug. Only limited information is available regarding side effects in humans. The following side effects have been observed in healthy subjects taking the study drug in completed studies at frequency more than 5% and at frequency higher than placebo: constipation (6%) and diarrhea (9%). Other possible side effects of the study compound are temporary reduction in the number of a type of white blood cells, called lymphopenia (this is expected due to the way of action of the study compound, and the number of white blood cells returned to normal after the study drug was discontinued) and delayed travel of electrical pulses in the heart (in prior studies with the study drug this was observed in 5 participants, the severity in all these reactions was mild and no treatment was necessary).

Side effects reported with the use of another similar drug that is currently in use for the treatment of Multiple Sclerosis (MS), could occur. Please note that patients with MS that reported some of the following side effects have been using this similar drug for an extended period.

The most common side effects (occurred in up to 1 in 10 people, 10%) are lung disorders, infection with herpes virus (shingles or herpes zoster), slow heart rate, basal cell carcinoma (a kind of skin cancer). Other side effects (occurred in up to 1 in 100 people, 1%) are pneumonia (with symptoms such as fever, cough, difficulty breathing), macular edema (with symptoms such as shadows or blind spots in the center of the vision, blurred vision, problems seeing colors or details) and reduction in blood platelets which increases risk of bleeding and bruising. In case you are interested in participating in this study, more information related to side effects of the similar drug will be discussed with you while the information form and statement of willingness to participate is being reviewed with you during the medical screening.

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 of age. You can only take part in the study if you do not smoke. Females are only allowed to participate in this study if they are using sufficient contraception (hormonal contraceptives or an intrauterine device combined with a barrier method, such as a condom) or if they have been postmenopausal for at least two years or if they have been surgically sterilized.

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 there will be restrictions for these products. 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 6 weeks before the start of the study and will consist of two visits: first you will visit our medical screening facility in Groningen (location Martini) for the medical screening. Once you are suitable for participation at that point, you will visit the Martini Hospital in Groningen on a separate occasion for an eye examination.

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Group 3b

€ 2.918,-

18 days stay

  • 21 Aug 2017 up to and including 7 Sep 2017

possible prolongation

  • Inapplicable

checkups

Inapplicable

Follow-up

Inapplicable
Group full

Group 4a

€ 2.918,-

18 days stay

  • 5 Sep 2017 up to and including 22 Sep 2017

possible prolongation

  • Inapplicable

checkups

Inapplicable

Follow-up

Inapplicable
Group full

Group 4b

€ 2.918,-

18 days stay

  • 13 Sep 2017 up to and including 30 Sep 2017

possible prolongation

  • Inapplicable

checkups

Inapplicable

Follow-up

Inapplicable
Group full

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