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

A Phase 1, Open-label, Randomized, Four-period, Four-sequence, Single-dose, Crossover Study In Healthy Volunteers, To Determine The Relative Bioavailability Of Pf-06291826 61 Mga Tafamidis Free Acid Soft Gelatin Capsules Compared To Commercial 4 × 20 Mg Tafamidis Meglumine Soft Gelatin Capsules Administered Under Fasted And Fed Conditions And The Effect Of Food On The Oral Bioavailability Of Pf-06291826 61 Mga Tafamidis Free Acid Soft Gelatin Capsules

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: tafamidis

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, B-1070
    • Pfizer Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 61 mgA tafamidis free acid soft gelatin capsule fed; fasted	Drug: tafamidis; bioavailability study
Experimental: 61 mgA tafamidis free acid soft gelatin capsule fasted; fed	Drug: tafamidis; bioavailability study
Experimental: 4 × 20 mg tafamidis meglumine soft gelatin capsules fed; fed	Drug: tafamidis; bioavailability study
Experimental: 4 × 20 mg tafamidis meglumine soft gelatin capsules fasted; fasted	Drug: tafamidis; bioavailability study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the concentration-time curve 0-72 hours (AUC72)	72 hrs
maximum observed plasma concentration (Cmax)	168 hrs

Secondary Outcome Measures

Outcome Measure	Time Frame
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	168 hrs
Mean residence time (MRT)	168 hrs
Time to Reach Maximum Observed Plasma Concentration (Tmax)	168 hrs
Plasma Decay Half-Life (t1/2)	168 hrs
Area under the curve from zero to infinity (AUCinf)	168 hrs

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2017
• Primary Completion (Actual): February 23, 2018
• Study Completion (Actual): February 23, 2018

Study Registration Dates

• First Submitted: September 5, 2017
• First Submitted That Met QC Criteria: September 11, 2017
• First Posted (Actual): September 12, 2017

Study Record Updates

• Last Update Posted (Actual): April 6, 2018
• Last Update Submitted That Met QC Criteria: April 5, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: B3461054; 2017-002769-23 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes