A Study Comparing the Amounts of 2 Different Forms of Tafamidis (PF06291826), Both With and Without Food, In the Blood

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

2017-09-29

Study Completion Date

2018-02-23

Brief Summary

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2 different formulations of tafamidis will be compared under both fed and fasted conditions. Subjects will be fasted overnight or fed. After swallowing one of the tafamidis formulations, tafamidis blood concentrations will be measured periodically for 8 days. After 16 days, subjects will take a different formulation in the fed or fasted state or take the same formulation in the opposite feeding condition. This will be repeated, 16 days apart, until all subjects have taken each formulation both fed and fasted.

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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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61 mgA tafamidis free acid soft gelatin capsule fed

fasted

Group Type EXPERIMENTAL

tafamidis

Intervention Type DRUG

bioavailability study

61 mgA tafamidis free acid soft gelatin capsule fasted

fed

Group Type EXPERIMENTAL

tafamidis

Intervention Type DRUG

bioavailability study

4 × 20 mg tafamidis meglumine soft gelatin capsules fed

fed

Group Type EXPERIMENTAL

tafamidis

Intervention Type DRUG

bioavailability study

4 × 20 mg tafamidis meglumine soft gelatin capsules fasted

fasted

Group Type EXPERIMENTAL

tafamidis

Intervention Type DRUG

bioavailability study

Interventions

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tafamidis

bioavailability study

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