The Pfizer Clinical Research Unit (PCRU) in Brussels is seeking healthy breastfeeding participants for a clinical trial of a study drug for the treatment of immune mediated inflammatory disorders including eosinophilic esophagitis and Crohn's disease.

This study will measure how much of the study drug is in your breastmilk and blood after you take multiple doses and will also assess the study drug’s safety.

Who may participate

This study is seeking breastfeeding participants. 

Participants must be healthy, meaning they will not have the condition for which this treatment is being developed and are in overall good health. 

Essential items are in place to welcome you with your baby: you have your own individual room, along with all necessary equipment for the infant.

You may not take part in this study if: 
  
-    You are outside of the limits for this study of age (18-55 years) or Body Mass Index (16- 35 kg/m2) or you weigh equal to or less than the limit for weight (45 kg).
-    You do not want to temporarily discontinue breastfeeding your child for a total period of 21 days, starting from the evening of the day before the administration of the study drug (Day -1) up to Day 21.
-    You do not agree to using a breast pump regularly or to not giving that breastmilk to your child during the breastfeeding interruption period.

There are other requirements for participation in this study. 

Please read attentively the Informed Consent Document (ICD), more explanation will be provided by the study staff during the screening process. 
 

Condition

Healthy

Age

18-55

Sex

Female

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

What to expect

If this study may be a fit for you, you’ll be invited to a screening visit at our facility in Brussels, Belgium. 

You will stay in the PCRU for 1 treatment period, comprised of 9 days and 8 nights (from Day -1 to Day 8). During this period, you will be asked not to breastfeed your child until 14 days after the last dose of Day 7, which corresponds to Day 21.

You will be screened within 28 days prior to the first dose of study intervention.

Throughout the study, staff will closely monitor your health status and collect data. If necessary, assistance from a breastfeeding expert designated by PCRU will be provided.

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.
 

How long is the study?

Approximately 10 weeks (dates coming soon)

Compensation

Up to € 2.480, plus travel fees