The Pfizer New Haven Clinical Research Unit is conducting a clinical trial of a study drug for ulcerative colitis. Part A of this study will compare the effects and breakdown (metabolism) of different formulations of the study drug when taken as single oral doses with or without food.
Ulcerative colitis (UC) is the most common type of inflammatory bowel disease and causes digestive upset, pain, and other symptoms that can negatively affect a patient’s quality of life. While, for some people, these symptoms can be reduced with lifestyle and diet changes, many patients require medication or other treatments to manage their disease.
However, even with these treatments, many patients continue to have flare-ups and currently-available medications can become less effective over time. More research is necessary to help identify new potential therapies to provide improved symptom management and more long-term solutions for patients.
Read on to learn how you can support patients as a healthy clinical trial volunteer.
Who may participate
All new medicines and vaccines are first tested in clinical trials with healthy volunteers. When you choose to participate, you become an essential part of future medical discoveries.
This study is seeking healthy adult volunteers, meaning that the participants will not have the condition being studied and are in overall good health. In addition to the criteria listed, participants must meet the following requirements:
- Willing to take a study drug
- Willing and able to come to our facility in New Haven, CT*
- Willing and able to comply with all study procedures
*participants may be eligible to receive a bonus for travel, ask our staff for details
There are other requirements for participation in this study. The study staff will explain these to you during the screening process.
Do you know someone who may meet these requirements? Refer a friend and you may be eligible to receive a bonus.
Condition
Healthy
Age
18-65 years
Sex
All sexes
Referral bonus
Up to $175
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 New Haven, CT. If you qualify for the study, there may be a period of up to 28 days before dosing.
If you choose to participate, you will stay at our facility 4 separate times for 4 consecutive nights each. On the morning after each check-in at our facility, you will receive a single oral dose of the study drug or placebo, for a total of up to 4 doses throughout the study. There will be at least 7 days between each dose, and each dose will be given as a liquid or a capsule to swallow that may be given with or without food.
About a week after your last dose, you will return to the unit for a short follow-up visit (this does not require an overnight stay).
Throughout the study, staff will closely monitor your health status and collect data, such as the levels of the study drug in your blood, urine, and stool.
*You may be asked to admit early for additional overnights during certain periods of the study. If this occurs, you will be compensated at a rate of $300 for each additional overnight.
Required overnight stays
16* planned overnights over 4 separate stays
Long-term follow up
1 follow-up visit, 1 phone call
How long is this study?
About 72 days
Compensation
Up to $6,516* upon completion of the study
All of the study procedures will be clearly explained to you during screening and can be viewed in the informed consent form.
The PCRU Loyalty Program has arrived!
Our new Loyalty Program offers unique tiered gifts for new and returning participants.
Interested in participating?
Complete and submit this form, and a Pfizer New Haven Clinical Research Unit (PCRU) representative will contact you.
You may also call 1-800-254-6398 and speak with a PCRU representative to learn more.
For Japanese language assistance only, please call 1-833-711-9984.
The personal data gathered here will be collected, processed, and maintained in a confidential manner. Your information will be stored in our research unit’s database. We may use this information to invite you to participate in current and future clinical studies at the PCRU. You will have full access to your records at the Pfizer New Haven Clinical Research Unit and the opportunity to correct them if necessary.