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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* 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. 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.

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: 61 mgA tafamidis free acid soft gelatin capsule fed<br>fasted | Drug: tafamidis<br>* bioavailability study<br>|
| Experimental: 61 mgA tafamidis free acid soft gelatin capsule fasted<br>fed | Drug: tafamidis<br>* bioavailability study<br>|
| Experimental: 4 × 20 mg tafamidis meglumine soft gelatin capsules fed<br>fed | Drug: tafamidis<br>* bioavailability study<br>|
| Experimental: 4 × 20 mg tafamidis meglumine soft gelatin capsules fasted<br>fasted | Drug: tafamidis<br>* bioavailability study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |