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

December 20, 2015 updated by: Pfizer

A Phase 1, Open-Label, Randomized, Single Dose Study To Estimate The Relative Bioavailability And Food Effect Of PF-06291826 (Tafamidis) Following Administration Of New Soft Gelatin Capsule Oral Formulations In Healthy Subjects

This is a 2 part study. In part 1 of the study, 3 different formulations of the same dose of tafamidis will be compared. Subjects will be fasted for each test and every subject will test all 3 different formulations. After swallowing tafamidis, tafamidis blood concentrations will be measured periodically for 6 days. After 14 days, subjects will take a different formulation of tafamidis and tafamidis blood concentrations will be measured periodically for 6 days. After another 14 days, the last formulation will be tested in the same way. In part 2 of the study, depending on the results of part 1, either none, one or 2 of the formulations tested in part 1 will be tested comparing the same formulation when given either with or without food. Additionally, depending on the results of part 1 of the study, different doses of the formulations may be compared.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

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

No

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.
  • Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception.

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 soft gel capsules of 20 mg tafamidis meglumine
Drug: tafamidis
relative bioavailability
Drug: tafamidis
fasted
Drug: tafamidis
fed
Experimental: 48.8 mg tafamidis soft gel capsule formulation 1
Drug: tafamidis
relative bioavailability
Drug: tafamidis
fasted
Drug: tafamidis
fed
Experimental: 48.8 mg tafamidis soft get capsule formulation 2
Drug: tafamidis
relative bioavailability
Drug: tafamidis
fasted
Drug: tafamidis
fed
Experimental: 61 mg tafamidis soft gel capsule formulation 1
Drug: tafamidis
relative bioavailability
Drug: tafamidis
fasted
Drug: tafamidis
fed
Experimental: 61 mg tafamidis soft gel capsule formulation 2
Drug: tafamidis
relative bioavailability
Drug: tafamidis
fasted
Drug: tafamidis
fed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the concentration-time Curve (AUC)
Time Frame: 120 hours
120 hours
Maximum Observed Plasma Concentration (Cmax)
Time Frame: 120 hours
120 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time Frame: 120 hours
120 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame: 120 hours
120 hours
Plasma Decay Half-Life (t1/2)
Time Frame: 120 hours
120 hours
Area Under the Curve from Time zero to infinity
Time Frame: 120 hours
120 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

September 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 25, 2015

First Submitted That Met QC Criteria

August 25, 2015

First Posted (Estimate)

August 28, 2015

Study Record Updates

Last Update Posted (Estimate)

December 22, 2015

Last Update Submitted That Met QC Criteria

December 20, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • B3461052
  • 2015-002315-15 (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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