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

NCT ID: NCT02534740

Last Updated: 2015-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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4 soft gel capsules of 20 mg tafamidis meglumine

Group Type EXPERIMENTAL

tafamidis

Intervention Type DRUG

relative bioavailability

48.8 mg tafamidis soft gel capsule formulation 1

Group Type EXPERIMENTAL

tafamidis

Intervention Type DRUG

relative bioavailability

tafamidis

Intervention Type DRUG

fed

48.8 mg tafamidis soft get capsule formulation 2

Group Type EXPERIMENTAL

tafamidis

Intervention Type DRUG

relative bioavailability

tafamidis

Intervention Type DRUG

fed

61 mg tafamidis soft gel capsule formulation 1

Group Type EXPERIMENTAL

tafamidis

Intervention Type DRUG

fasted

61 mg tafamidis soft gel capsule formulation 2

Group Type EXPERIMENTAL

tafamidis

Intervention Type DRUG

fasted

Interventions

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tafamidis

relative bioavailability

Intervention Type DRUG

tafamidis

fasted

Intervention Type DRUG

tafamidis

fed

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Clinical Research Unit

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2015-002315-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B3461052

Identifier Type: -

Identifier Source: org_study_id