HEALTHY VOLUNTEERS NEEDED-B3461095

Study Graphic

Study number: B3461095

You may qualify to participate if you are:

  • a healthy male or female (unable to bear children) 18-55 years of age.
  • able to meet all eligibility criteria.
  • able to comply with all study visits

Compensation: You will be compensated for your time up to $4,500.00 for completion of the study.

The Pfizer New Haven Clinical Research Unit is conducting a study of is conducting a study of the study drug, tafamidis. Tafamidis is a marketed TTR amyloid inhibitor used to treat people with amyloidosis. Single and multiple doses of the study drug up to 80mg are generally well tolerated. The usual dose of the study drug to treat amyloidosis is 20 mg daily. In this study, you will receive a single, oral 12.2 mg dose of the study drug in an investigational formulation and a single oral 20mg dose of the current commercial formulation. You will receive the study drug or commercial formulation on 2 occasions at least 16 days apart.

“Investigational formulation” means that the amount of drug and the form that it is in

(e.g., liquid) has not been approved by the United States Food and Drug Administration (FDA)

This study involves:

  • 2 dosing periods during 2 admissions
  • 16 overnight stays; 8 per admission
  • 1 follow-up phone call

You will be in this study up to about 50 days. This does not include the time between screening and dosing, which can be up to 28 days.

There will be at least 16 days between each dose.

Up to 22 healthy male and female subjects, will be in this study. Females must be unable to have children.

Please review the informed consent document: B3461095 ICD IRB approved 03Sep2020