A Study Comparing Amounts of Tafamidis In The Blood Without Food

Pfizer12 enrolled

Overview

3 different formulations and doses 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

tafamidisDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pfizer Clinical Research Unit

Brussels, Belgium

Outcomes

Primary Outcomes

Area under the concentration-time Curve (AUC)

Time frame: 120 hours

Maximum Observed Plasma Concentration (Cmax)

Time frame: 120 hours

Secondary Outcomes

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

Time frame: 120 hours

Mean residence time (MRT)

Time frame: 120 hours

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Time frame: 120 hours

Plasma Decay Half-Life (t1/2)

Time frame: 120 hours

Data from ClinicalTrials.gov

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