Qui peut participer

This study is seeking healthy male and female participants, meaning that the participants will not have the condition being studied.

In addition to the criteria listed, participants must meet the following requirements:

For Women:

  • Be a woman of non-childbearing potential. This means that you are either post-menopausal or that you have been surgically sterilized.

OR

  • Be a woman of childbearing potential who fulfills one of the criteria listed below:
    • Have had a bilateral tubal occlusion
    • Have a non-hormonal IUD
    • Have a hormonal IUS
    • You have a (progestogen-only) hormonal implant
    • Have a partner who has undergone a vasectomy at least six months ago.

 

For Both Sexes:

  • Have a minimum body weight of 50 kg
  • Have body Mass Index of 17.5 - 30.5 kg/m2
  • Be a non-smoker or a smoker who smokes a maximum of 5 cigarettes per day
  • Be able to meet all study visit requirements

 

There are other requirements for participation in this study. The study staff will explain these to you during the screening process.

 

Condition
Healthy
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Age
18-60 years
The age a person must be to participate in a clinical trial
Sex
Males and females
The sex of people who may participate in a clinical trial. Sex is a person's classification based on assignment at birth. Eligibility based on sex is distinct from eligibility based on gender
Afficher plus de critères d’éligibilité

Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can fully determine if you qualify to enroll in the study.

À quoi faut-il s’attendre ?

The study is planned to last for approximately 10 weeks. There are several examinations procedures will be required in connection with the study:

  • A screening examination
  • A hospitalisation period of 8 days (7 nights)
  • A follow-up phone call

Each participant will have a follow-up phone call 28 to 35 days after administration of the last dose of study medicine.

You will not personally derive any benefit from your participation in this study, but the results obtained could be very important for the development of medicines and treatments which will benefit other people.

Required Over Night Stay
An hospitaisation period of 7 nights in the Unit
A participant may be required to stay overnight at the PCRU for observation and study procedures. The number and length of overnight stays is determined by the design of the study
Long term follow-up
1 follow-up phonecall
Some studies require the study team to stay in contact with the participant for a period of time after he or she completes the main part of the study. This long-term follow up is to collect additional information on the study drug over time
How long is the study?
Approximately 10 weeks
The length of the study includes the time from screening until the final follow-up call or study activity. There may be up to 28 days between screening and dosing
Compensation
€ 1515, plus € 210 and plus transportation fees
Participants in clinical trials at the PCRU receive financial compensation for their participation. The amount depends on factors like length of the stay, total number of study visits, and the nature of the study procedures

Intéressé à participer?

Nouveau dans la recherche clinique ?
Si vous souhaitez devenir participant ou avez besoin de plus d'informations sur le processus d'inscription, veuillez remplir et envoyer le formulaire d'inscription. Nous vous contacterons dès que possible.

Déjà dans notre base de données?
Si vous souhaitez vous inscrire à cette étude, veuillez nous contacter par téléphone.

Pour plus de renseignements, appelez le 0800/99.256 (de l’étranger: +32 2.556.70.02) ou un courriel.

Par données personnelles, on entend toute information vous concernant en tant que personne physique, comme par exemple votre nom, votre date de naissance, votre numéro de téléphone ou les informations relatives à votre santé ou à votre pathologie médicale.

Les données personnelles que vous nous communiquerez en remplissant ce formulaire sont recueillies par la PCRU en vue de vous envoyer de la documentation et le formulaire d’inscription. Elles seront traitées de façon strictement confidentielle et conformément aux règlements actuels, en particulier les lois belges et européennes applicable aux essais cliniques, ainsi que les lois belges et européennes applicables à la protection des données personnelles.

La protection des données personnelles est très importante pour notre unité de recherche clinique. C’est pourquoi nous vous demandons de lire notre avis de confidentialité (la « notice d’information »), disponible à l’adresse

https://privacycenter.pfizer.com/fr/belgium

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