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Safety And Pharmacokinetic Assessment Of Orally Administered Tafamidis In Healthy Volunteers

NCT ID: NCT01655511

Last Updated: 2012-09-27

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

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2012-09-30

Brief Summary

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This study in healthy male and female volunteers will investigate the safety and tolerability of three increasing oral doses of tafamidis

Detailed Description

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Conditions

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TTR Cardiomyopathy

Keywords

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Pharmacokinetic pharmacodynamic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Period 1

240 mg tafamidis arm

Group Type EXPERIMENTAL

Tafamidis

Intervention Type DRUG

240 mg, solution, single dose

Period 2

480 mg arm

Group Type EXPERIMENTAL

Tafamidis

Intervention Type DRUG

480 mg, solution, single dose

Period 3

TBD dose

Group Type EXPERIMENTAL

Tafamidis

Intervention Type DRUG

TBD dose will be a single dose if \< 720 mg or a loading dose followed by additional dose if \> 720 mg.

Interventions

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Tafamidis

240 mg, solution, single dose

Intervention Type DRUG

Tafamidis

480 mg, solution, single dose

Intervention Type DRUG

Tafamidis

TBD dose will be a single dose if \< 720 mg or a loading dose followed by additional dose if \> 720 mg.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy, males or females, 21 to 55 years old.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.

Exclusion Criteria

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

Condition affecting drug absorption. Blood pressure or ECG abnormalities. Recent treatment with an investigational, prescription, or non-prescription drug
Minimum Eligible Age

21 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

Singapore, Singapore, Singapore

Site Status

Countries

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Singapore

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3461040&StudyName=Safety%20And%20Pharmacokinetic%20Assessment%20Of%20Orally%20Administered%20Tafamidis%20In%20Healthy%20Volunteers

To obtain contact information for a study center near you, click here.

Other Identifiers

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B3461040

Identifier Type: -

Identifier Source: secondary_id

B3461040

Identifier Type: -

Identifier Source: org_study_id