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

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NCT02534740

Last updated on March 22, 2018

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About this Study

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 Location

Pfizer Clinical Research Unit

Brussels, , B-1070 Belgium

See other locations

Contact

1-800-718-1021

[email protected]

Eligibility criteria

Condition

Healthy

Sex

Females and Males

Age

18-55 years

Inclusion criteria

Show details

- 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

Show details

- 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.

NCT02534740

Pfizer

Completed

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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: tafamidis
relative bioavailability
Drug: tafamidis
fasted
Drug: tafamidis
fed

Study Arms

Experimental: 4 soft gel capsules of 20 mg tafamidis meglumine
Intervention: Drug: tafamidis
Experimental: 48.8 mg tafamidis soft gel capsule formulation 1
Interventions:
- Drug: tafamidis
- Drug: tafamidis
Experimental: 48.8 mg tafamidis soft get capsule formulation 2
Interventions:
- Drug: tafamidis
- Drug: tafamidis
Experimental: 61 mg tafamidis soft gel capsule formulation 1
Intervention: Drug: tafamidis
Experimental: 61 mg tafamidis soft gel capsule formulation 2
Intervention: Drug: tafamidis

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2015

Primary Completion Date

December 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 55 Years (Adult)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Belgium

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT02534740

Other Study ID Numbers ^ICMJE

B3461052
2015-002315-15 ( EudraCT Number )

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

PRS Account

Pfizer

Verification Date

December 2015

^ICMJE Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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