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

Pfizer18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

tafamidisDRUG

bioavailability study

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 0-72 hours (AUC72)

Time frame: 72 hrs

maximum observed plasma concentration (Cmax)

Time frame: 168 hrs

Secondary Outcomes

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

Time frame: 168 hrs

Mean residence time (MRT)

Time frame: 168 hrs

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Time frame: 168 hrs

Plasma Decay Half-Life (t1/2)

Time frame: 168 hrs

Area under the curve from zero to infinity (AUCinf)

Time frame: 168 hrs

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.