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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: tafamidis

• Registration Number: NCT02406560
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-30
• Study First Submitted QC: 2015-03-30
• Study Start: 2015-04
• Study First Posted: 2015-04-02
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-06
• Last Update Posted: 2015-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
4 tablets of 12.2 mg tafamdis free acid	tafamidis	-
4 tablets of 12.2 mg tafamidis free acid	tafamidis	-
5 tablets of 12.2 mg tafamidis free acid	tafamidis	-

Primary Outcome Measures

Name	Time	Method
Area under the Concentration-Time Curve (AUC)	168 hours	AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Maximum Observed Plasma Concentration (Cmax)	168 hours

Secondary Outcome Measures

Name	Time	Method
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	168 hours	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time to Reach Maximum Observed Plasma Concentration (Tmax)	168 hours
Plasma Decay Half-Life (t1/2)	168 hours	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Trial Locations

Locations (1)

Pfizer Clinical Research Unit; 🇧🇪 Brussels, Belgium