Who may participate

cropped teal people iconPeople who take part in clinical trials are key to advancing medical research. This study is seeking healthy male or female 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:

  • Females must use a highly-effective, non-hormonal method of birth control
  • Able and willing to abstain from certain foods prior to and throughout study participation
  • Willing to take a study drug 
  • 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
18-55 years
The age a person must be to participate in a clinical trial.
Sex
Male or Female
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
Smoking Status
Non-Smoker or Ex-smoker (>3 months)
Whether or not a person uses tobacco and nicotine-containing products.

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

cropped clipboard icon If this study may be a fit for you, you will be invited to attend 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 begins.

You will stay for 13 consecutive nights at our facility. During your stay you will receive one oral dose of caffeine, multiple once-daily oral doses of the study drug, and one dose of both caffeine and the study drug together.

Throughout the study, staff will monitor your health status, ask how you are feeling, and collect other data, such as the levels of caffeine and the study drug in your blood. A follow-up call will occur about 28-35 days after your last dose.

Required overnight stays
13 consecutive nights
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 phone call
Some studies require the study team to stay in contact with the participant for a period of time after the participant 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 this study?
About 42 days
This does not include the time between screening and dosing, which can be up to 28 days. Participants will be in this study for about 42 days between the first dose and final follow-up call.
Compensation
Up to $3650 upon completion of the study
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?

Complete and submit this form, and a Pfizer 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.

The personal data gathered here will be collected, processed, and maintained in a confidential manner. Your information will be stored in our research units database. We may use this information to invite you to participate in this clinical study, as well as other 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.

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