A Study To Estimate How Much Tafamidis Created In Different Ways Can Be Measured in Blood Samples

Study Overview
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Brief Summary
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All subjects in this study will be given tafamidis. After swallowing a single pill of tafamidis, measurements including blood samples will be compared to see if tafamidis made in different ways is about the same. After approximately 28 days subjects will be given another pill of tafamidis and the study measurements will be repeated.

Official Title
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A Phase 1, Open-Label, Randomized, 2-Cohort, Crossover, Single Dose Study to Estimate the Relative Bioavailability of PF 06291826 (Tafamidis) Following Administration of Two Oral Formulations Versus Commercial Capsule in Healthy Subjects Under Fasted Conditions

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Tafamidis
* Drug: Tafamidis
* Drug: Tafamidis
* Drug: Tafamidis
* Drug: Tafamidis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tafamidis<br> | Drug: Tafamidis<br>* 20 mg of current commercial formulation.<br>|
| Experimental: Tafamudus Free Acid<br> | Drug: Tafamidis<br>* 12.2 mgA free acid tablet.<br>|
| Experimental: 20 mg new soft gelatin capsule<br> | Drug: Tafamidis<br>* 20 mg new soft gelatin capsule.<br>|
| Experimental: 4 capsules of 20 mg tafamidis of commercial formulation<br> | Drug: Tafamidis<br>* 4 capsules of 20 mg tafamidis of current commercial formulation.<br>|
| Experimental: 4 capsules of 12.2 mg tafamidis of free acid tablet<br> | Drug: Tafamidis<br>* 4 capsules of 12.2 mg tafamidis of free acid tablet..<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] | AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). | 168 hours | 
| Maximum Observed Plasma Concentration (Cmax) |  | 168 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | 6 |