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

NCT ID: NCT02189330

Last Updated: 2014-07-15

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

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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Tafamidis

Group Type EXPERIMENTAL

Tafamidis

Intervention Type DRUG

20 mg of current commercial formulation.

Tafamudus Free Acid

Group Type EXPERIMENTAL

Tafamidis

Intervention Type DRUG

12.2 mgA free acid tablet.

20 mg new soft gelatin capsule

Group Type EXPERIMENTAL

Tafamidis

Intervention Type DRUG

20 mg new soft gelatin capsule.

4 capsules of 20 mg tafamidis of commercial formulation

Group Type EXPERIMENTAL

Tafamidis

Intervention Type DRUG

4 capsules of 20 mg tafamidis of current commercial formulation.

4 capsules of 12.2 mg tafamidis of free acid tablet

Group Type EXPERIMENTAL

Tafamidis

Intervention Type DRUG

4 capsules of 12.2 mg tafamidis of free acid tablet..

Interventions

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Tafamidis

20 mg of current commercial formulation.

Intervention Type DRUG

Tafamidis

12.2 mgA free acid tablet.

Intervention Type DRUG

Tafamidis

20 mg new soft gelatin capsule.

Intervention Type DRUG

Tafamidis

4 capsules of 20 mg tafamidis of current commercial formulation.

Intervention Type DRUG

Tafamidis

4 capsules of 12.2 mg tafamidis of free acid tablet..

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.
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 Investigational Site

Brussels, , Belgium

Site Status

Countries

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Belgium

Related Links

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Other Identifiers

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B3461030

Identifier Type: -

Identifier Source: org_study_id

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