Who may participate

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
View more eligibility criteria

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.

What to expect

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

Interested in participating?

 

New to clinical research? If you’re interested in becoming a participant or need more information on the registration process, please complete and submit the registration form. We will contact you as soon as possible 

Already in our database? If you’d like to subscribe for this study, please contact us by phone. 

Studies (recruiters) For more information, call 0800/99.256 (from abroad: 0032/2. 556.70.02 or 00800/2636.2636 from France, The Netherlands, Germany, UK) or email us.  

Personal data means any information relating to you as a natural person such as for example your name, your date of birth, your telephone number or information relating to your health or your medical condition.

The personal data you share with us when completing the registration form is collected by the Brussels PCRU in order to send you the relevant literature and the medical questionnaire. It will be processed in a strictly confidential manner and in conformity with all applicable legislations, especially the European and Belgian laws applicable to clinical trials, and the European and Belgian laws applicable to personal data protection.

Personal data protection is very important to our clinical research unit. That’s why we ask that you read our Privacy Notice available at https://privacycenter.pfizer.com/en/belgium.

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