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

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Open-label, Randomized, Crossover, Oral, Single Dose Study To Estimate The Relative Bioavailability Of Pf-06291826 (Tafamidis) Following Administration Of A Tafamidis Free Acid Tablet Formulation In Healthy Subjects Under Fasted And Fed Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02406560
• Other study ID #: B3461050
• Secondary ID: 2015-000706-19
• Status: Completed
• Phase: Phase 1
• First received: March 30, 2015
• Last updated: August 6, 2015
• Start date: April 2015
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• tafamidis
fasted
• tafamidis
high fat meal
• tafamidis

Locations

Country	Name	City	State
Belgium	Pfizer Clinical Research Unit	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the Concentration-Time Curve (AUC)	AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.	168 hours	No
Primary	Maximum Observed Plasma Concentration (Cmax)		168 hours	No
Secondary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)	168 hours	No
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax)		168 hours	No
Secondary	Plasma Decay Half-Life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	168 hours	No