PRA-19649X

Cold virus

Study of a new compound for the treatment of lower respiratory tract infection (RS-virus)

Particulars

  • You are between 18 and 55 years old.
  • You do not smoke.
  • Your weight is a minimum of 50 kg and your Body Mass Index (BMI) is between 18.0 and 30.0 kg/m2
  • As a male you are only allowed to participate in this study if: 
    • you use a condom
  • As a female you are only allowed to participate in this study if:
    • you have been surgically sterilized at least 6 months before screening;
    • or you have been postmenopausal for at least a year (without menstrual periods).
  • You have not participated in any other drug study within 60 days (in special cases 3 months) preceding the first administration of the study compound.
  • To determine if you are eligible to participate in this study, you will undergo a medical screening.
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Compensation

For group 1 you will receive a gross compensation of € 3698 for full participation in this group.
For group 2 you will receive a gross compensation of € 3714 for full participation in this group.

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, irrespective of the method of transportation.

Period of stay and research

For groups 1 and 2, the study consists of 4 periods. During each period you will stay for 7 days (6 nights) in the research center in Groningen. The follow-up screening will take place on the last day of the 4th period in the research center.

Please note: You have to be available for all dates of the chosen group to be able to participate in this study. The actual dates are published on our website. However, these may be subject to change.

More info

Type of study

Soon a new research study will start at PRA of a new compound in the treatment of lower respiratory tract infection (RS-Virus).

This new compound may potentially be used for the treatment of infections with the respiratory syncytial virus (RS-virus). The RS-virus is a common virus that causes common colds. However, especially in very young children an infection with this virus can result in lower respiratory tract infections and can cause very serious pneumonia. Also, elderly persons and persons with underlying chronic diseases or a diminished immunity are at risk of developing serious illness. The compound is able to inhibit the RS-virus by inhibiting the viral protein production.

The purpose of this study is to investigate how quickly and to what extent the compound is absorbed, distributed, metabolized and eliminated from the body (this is called pharmacokinetics). The pharmacokinetics of the compound when it is administered following the intake of a high-fat breakfast will be compared to the pharmacokinetics of the compound when it is administered following the intake of a different kind of breakfast or after fasting.

Further, it will be investigated how safe the compound is and how well it is tolerated. The comound has been administered to humans before.

This study does not aim to improve your health, but is necessary for the further development of these compounds. The study will only take place after it has been approved by the Independent Ethics Committee.

RS-virus

The RS-virus is a common virus that causes common colds. However, especially in very young children an infection with the RS-virus can result in lower respiratory tract infections and can cause very serious pneumonia. Also, elderly persons and persons with underlying chronic diseases or a diminished immunity are at risk of developing serious illness.

Setup and duration of the study

For groups 1 and 2, the study consists of 4 periods. During each period you will stay for 7 days (6 nights) in the research center in Groningen. The follow-up screening will take place on the last day of the 4th period in the research center.

The study consists of 4 treatment periods. In each treatment period, you will receive a single dose of the compound. The breakfast type that you will receive prior to administration of the compound is different in each period. You will receive the high-fat breakfast in one of the 4 periods and you will receive another type of breakfast or you keep on fasting in the other 3 periods. There will be 16 different breakfast orders in this study and you will be assigned to one of these orders.

Each of the breakfast types must be started exactly on time in the morning and must be finished within 20 minutes. In each period, the entire breakfast must be consumed.

You can find the exact dates of each group on our website. If the dates do change you will be notified as soon as possible. Upon admission to the clinic you must have fasted for at least 10 hours. Before the start of the study you will visit the medical screening center for a medical screening. Blood samples will be taken regularly during the study.

Risks and medical supervision

All potential drugs can cause side effects.

The study compound is currently being evaluated in an ongoing study involving healthy subjects. To date, 120 healthy volunteers have received a single or multiple dose of the study drug. Tested doses were safe and well tolerated. The following side effects have been reported in the ongoing clinical trial with this compound: dizziness, headache/migraines, inflammation of the nasal cavities, upset stomach/heart burn, back pain, sleeplessness, sleepiness, elevated levels of lipase (an enzyme secreted by the pancreas which plays a role in helping to breakdown dietary fats) in the blood. It is not certain if these side effects are related to this compound. All side effects were mild or moderate.

You should be aware that still unknown side effects may occur during the study. You will be under strict medical supervision during 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 weight is at least 50 kilograms and your Body Mass Index (BMI) is between 18.0 and 30.0 kg/m2 (The BMI reflects the relationship between your body weight in kilograms and your height in meters). You can only take part in the study if you do not smoke.

Male volunteers who are sexual active have to use a condom to prevent passage of sperm to another person even if you are sterilized. To protect unborn or breastfed babies, you must not have sex with a woman who is pregnant or breastfeeding, during the study.

As a female you can participate if you are infertile, so post-menopausal for a minimum of 12 months or sterile.

The study will be executed under standardized conditions. Use of your own medication, alcohol, regular coffee and tea, cola, power drinks, chocolate (including chocolate milk), grapefruit (including juice) and tobacco products during the study is not allowed. Also before the study and each period there may 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; this screening will take place within three weeks before the start of the study.

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Groups

Group 1

Full

4× 7 days stay

  • 28 Oct 2019 up to and including 3 Nov 2019
  • 11 Nov 2019 up to and including 17 Nov 2019
  • 25 Nov 2019 up to and including 1 Dec 2019
  • 9 Dec 2019 up to and including 15 Dec 2019
€ 3.698,- Select

Group 2

Full

4× 7 days stay

  • 4 Nov 2019 up to and including 10 Nov 2019
  • 18 Nov 2019 up to and including 24 Nov 2019
  • 2 Dec 2019 up to and including 8 Dec 2019
  • 17 Dec 2019 up to and including 23 Dec 2019

note

Medical screening also possible on Saturday.

€ 3.714,- Select

Group 3

Full

4× 7 days stay

  • 11 Nov 2019 up to and including 17 Nov 2019
  • 25 Nov 2019 up to and including 1 Dec 2019
  • 9 Dec 2019 up to and including 15 Dec 2019
  • 17 Dec 2019 up to and including 23 Dec 2019
€ 3.822,- Select