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

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-06-30

Brief Summary

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Each subject will be given tafamidis after either a high fat meal or while fasted. After swallowing tafamidis, tafamidis blood concentrations will be measured periodically for one week. After about 14 days, subjects will take either a different dose of tafamidis or the same dose under the opposite meal condition. Tafamidis concentrations from the three different conditions will be compared to determine if they are approximately the same.

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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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4 tablets of 12.2 mg tafamdis free acid

Group Type EXPERIMENTAL

tafamidis

Intervention Type DRUG

fasted

4 tablets of 12.2 mg tafamidis free acid

Group Type EXPERIMENTAL

tafamidis

Intervention Type DRUG

high fat meal

5 tablets of 12.2 mg tafamidis free acid

Group Type EXPERIMENTAL

tafamidis

Intervention Type DRUG

Interventions

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tafamidis

fasted

Intervention Type DRUG

tafamidis

high fat meal

Intervention Type DRUG

tafamidis

Intervention Type DRUG

Other Intervention Names

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fasted

Eligibility Criteria

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Inclusion Criteria

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