A Study Comparing The Amounts of Tafamidis In The Blood With Or Without Food

August 6, 2015 updated by: Pfizer

A Phase 1, Open-label, Randomized, Crossover, Oral, Single Dose Study To Estimate The Relative Bioavailability Of Pf-06291826 (Tafamidis) Following Administration Of A Tafamidis Free Acid Tablet Formulation In Healthy Subjects Under Fasted And Fed Conditions

Each subject will be given tafamidis after either a high fat meal or while fasted. After swallowing tafamidis, tafamidis blood concentrations will be measured periodically for one week. After about 14 days, subjects will take either a different dose of tafamidis or the same dose under the opposite meal condition. Tafamidis concentrations from the three different conditions will be compared to determine if they are approximately the same.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, B-1070
        • Pfizer Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria: - Healthy males or females of non-child bearing potential. - Body Mass Index (BMI) of 17.5 to 30.5 and total body weight more than 50 kg (110 lbs).

Exclusion Criteria: - Blood pressure at screening visit of greater than 140 mm Hg (systolic) or 90 mg Hg (diastolic). - Use of prescription or nonprescription drugs supplements within 7 days prior to 7 days of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 4 tablets of 12.2 mg tafamdis free acid
Drug: tafamidis
Other Names:
  • fasted
Drug: tafamidis
fasted
Drug: tafamidis
high fat meal
Experimental: 4 tablets of 12.2 mg tafamidis free acid
Drug: tafamidis
Other Names:
  • fasted
Drug: tafamidis
fasted
Drug: tafamidis
high fat meal
Experimental: 5 tablets of 12.2 mg tafamidis free acid
Drug: tafamidis
Other Names:
  • fasted
Drug: tafamidis
fasted
Drug: tafamidis
high fat meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax)
Time Frame: 168 hours
168 hours
Area under the Concentration-Time Curve (AUC)
Time Frame: 168 hours
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
168 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: 168 hours
168 hours
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time Frame: 168 hours
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
168 hours
Plasma Decay Half-Life (t1/2)
Time Frame: 168 hours
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
168 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

March 30, 2015

First Submitted That Met QC Criteria

March 30, 2015

First Posted (Estimate)

April 2, 2015

Study Record Updates

Last Update Posted (Estimate)

August 7, 2015

Last Update Submitted That Met QC Criteria

August 6, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • B3461050
  • 2015-000706-19 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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