A Study To Estimate How Much Tafamidis Created In Different Ways Can Be Measured in Blood Samples

July 14, 2014 updated by: Pfizer

A Phase 1, Open-Label, Randomized, 2-Cohort, Crossover, Single Dose Study to Estimate the Relative Bioavailability of PF 06291826 (Tafamidis) Following Administration of Two Oral Formulations Versus Commercial Capsule in Healthy Subjects Under Fasted Conditions

All subjects in this study will be given tafamidis. After swallowing a single pill of tafamidis, measurements including blood samples will be compared to see if tafamidis made in different ways is about the same. After approximately 28 days subjects will be given another pill of tafamidis and the study measurements will be repeated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

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 Investigational Site

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: Tafamidis
Drug: Tafamidis
20 mg of current commercial formulation.
Drug: Tafamidis
12.2 mgA free acid tablet.
Drug: Tafamidis
20 mg new soft gelatin capsule.
Drug: Tafamidis
4 capsules of 20 mg tafamidis of current commercial formulation.
Drug: Tafamidis
4 capsules of 12.2 mg tafamidis of free acid tablet..
Experimental: Tafamudus Free Acid
Drug: Tafamidis
20 mg of current commercial formulation.
Drug: Tafamidis
12.2 mgA free acid tablet.
Drug: Tafamidis
20 mg new soft gelatin capsule.
Drug: Tafamidis
4 capsules of 20 mg tafamidis of current commercial formulation.
Drug: Tafamidis
4 capsules of 12.2 mg tafamidis of free acid tablet..
Experimental: 20 mg new soft gelatin capsule
Drug: Tafamidis
20 mg of current commercial formulation.
Drug: Tafamidis
12.2 mgA free acid tablet.
Drug: Tafamidis
20 mg new soft gelatin capsule.
Drug: Tafamidis
4 capsules of 20 mg tafamidis of current commercial formulation.
Drug: Tafamidis
4 capsules of 12.2 mg tafamidis of free acid tablet..
Experimental: 4 capsules of 20 mg tafamidis of commercial formulation
Drug: Tafamidis
20 mg of current commercial formulation.
Drug: Tafamidis
12.2 mgA free acid tablet.
Drug: Tafamidis
20 mg new soft gelatin capsule.
Drug: Tafamidis
4 capsules of 20 mg tafamidis of current commercial formulation.
Drug: Tafamidis
4 capsules of 12.2 mg tafamidis of free acid tablet..
Experimental: 4 capsules of 12.2 mg tafamidis of free acid tablet
Drug: Tafamidis
20 mg of current commercial formulation.
Drug: Tafamidis
12.2 mgA free acid tablet.
Drug: Tafamidis
20 mg new soft gelatin capsule.
Drug: Tafamidis
4 capsules of 20 mg tafamidis of current commercial formulation.
Drug: Tafamidis
4 capsules of 12.2 mg tafamidis of free acid tablet..

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 Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Time Frame: 168 hours
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
168 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: 6
6

Collaborators and Investigators

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

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

May 1, 2014

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

May 15, 2014

First Submitted That Met QC Criteria

July 10, 2014

First Posted (Estimate)

July 14, 2014

Study Record Updates

Last Update Posted (Estimate)

July 15, 2014

Last Update Submitted That Met QC Criteria

July 14, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • B3461030

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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