PRA-19644X

Hepatitis B

Study of an investigational compound that is being developed for the treatment of chronic hepatitis B

Besonderheiten (auf Englisch)

  • You are between 18 and 45 years old
  • You do not smoke or do use other nicotine containing products
  • Your Body Mass Index (BMI) is between 19.0 and 30.0 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 non-hormonal contraception (intrauterine device, IUD) or if they (or their partner) have been surgically sterilized.
  • Men with fertile female partners are allowed to participate only if they are using a condom in combination with a contraceptive measure by their female partner or if they have been surgically sterilized.
  • You cannot have participated in another clinical trial in the 60 days before the start of this study.
  • To determine if you are suitable to participate in this study, you will undergo a medical screening. This will be performed in Groningen. When you pass the medical screening a second appointment will be made to perform an X-ray of the chest. In addition, you will also have an ophthalmological exam for group 5. This X-ray and ophthalmological exam will be performed in Groningen and is planned based on availability.
BMI berechnen

Vergütung (auf Englisch)

For participation in group 4 of the study, you will receive a gross compensation of € 1832,-.

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.

Periode und Studie (auf Englisch)

The study consists of maximally 4 groups. Based on the results in the previous group(s), it will be decided if the next group will be performed. You can participate in one of the groups.

Group 4 consists of 1 period during which you will stay in our research facility in Groningen for 13 days (12 nights).

For all groups there will be a follow-up visit between 5 and 9 days after discharge from the research facility.

Please note: You have to be available for all dates of the group of choice to be able to participate in this study.
The actual study dates will be published on our website. These are the currently planned dates; however, these
may be subject to change.

Sonstige Information (auf Englisch)

Type of study

Soon a research study will start at PRA with an investigational study drug that may eventually be used for the treatment of chronic hepatitis B. The purpose of the study is to investigate how quickly and to what extent the study medication is absorbed and eliminated from the body (this is called pharmacokinetics). This will be studied when the compound is administered alone or together with voriconazole and itraconazole. The extent to which the study medication is safe and tolerated will also be investigated. The study drug is not registered but has been given to humans before. Voriconazole and itraconazole are both registered and already available on the market. The study will only take place after it has been approved by the Medical Research Ethics Committee.

Setup and duration of the study

The study consists of maximally 5 groups. Based on the results in the previous group(s), it will be decided if the next group will be performed.

Group 1 consists of 1 period during which you will stay in our research facility in Groningen for 24 days (23 nights). There will be a follow-up visit between 5 and 9 days after discharge from the research facility. Before the start of the study you will visit the medical screening center in Groningen or Utrecht. In addition, an X-ray of the chest will be made during a separate appointment in Groningen. You will receive the study drug orally once daily on 3 separate days in the form of a tablet. In addition, voriconazole will be administered orally twice daily on 7 consecutive days. Itraconazole will be administered orally at least once daily on 9 consecutive days.

Groups 2 & 3 consist of 1 period during which you will stay in our research facility in Groningen for 18 days (17 nights). There will be a follow-up visit between 5 and 9 days after discharge from the research facility. Before the start of the study you will visit the medical screening center in Groningen or Utrecht. In addition, an X-ray of the chest will be made during a separate appointment in Groningen. You will receive the study drug orally once daily on 2 separate days in the form of a tablet. In addition, rifampicin (group 2) or rifabutin (group 3) will be administered orally once daily on 13 consecutive days.

Group 4 consist of 1 period during which you will stay in our research facility in Groningen for 13 days (12 nights). There will be a follow-up visit between 5 and 9 days after discharge from the research facility. Before the start of the study you will visit the medical screening center in Groningen or Utrecht. In addition, an X-ray of the chest will be made during a separate appointment in Groningen. You will receive the study drug orally once daily on 9 consecutive days in the form of a tablet. In addition, midazolam will be administered orally once daily on 2 separate days

Blood samples will be taken and urine will be collected regularly during the study.

Risks and medical supervision

The study compound reacts with an enzyme that decreases the number of immune cells in the body. By blocking this enzyme, the number of immune cells increases and the body can better fight the infection increasing the chance to clear the infection, even if this is a chronic infection. All medication may cause side effects. The study compound has been administered to humans before. In 75 healthy volunteers the most observed side effects were headache, diarrhea and nausea. In addition, voriconazole and itraconazole may also cause side effects. For both drugs the most important side effects are shortness of breath, fever, headache and skin rash. 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 45 years old and your Body Mass Index (BMI) is between 19.0 and 30.0 kg/m2. The BMI shows the relationship between body weight in kilograms and length in meters. You can only take part in the study if you do not smoke. Women must use non-hormonal methods of contraception (birth control), be postmenopausal or you (or your partner) must have been surgically sterilized in order to participate in this study. Men with fertile female partners are only allowed to participate in this study if you use a condom in combination with a second contraceptive measure by your female partner or 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 (milk), 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 (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 four weeks before the start of the study.

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Registrieren Sie sich unverbindlich für eine der unten aufgeführten Studiengruppen

Group 1a

24 Tage Aufenthalt

  • 5 Feb 2020 bis einschl. 28 Feb 2020

Nachuntersuchung

  • Nach Vereinbarung
€ 3.238,- Wählen

Group 1b

24 Tage Aufenthalt

  • 11 Feb 2020 bis einschl. 5 Mär 2020

Nachuntersuchung

  • Nach Vereinbarung
€ 3.238,- Wählen
Volle Studien anzeigen

Group 4a

Voll

13 Tage Aufenthalt

  • 7 Jan 2020 bis einschl. 19 Jan 2020

Nachuntersuchung

  • Nach Vereinbarung
€ 1.832,- Wählen

Group 4b

Voll

13 Tage Aufenthalt

  • 22 Jan 2020 bis einschl. 3 Feb 2020

Nachuntersuchung

  • Nach Vereinbarung
€ 1.832,- Wählen