A Study Comparing Amounts of 2 Different Forms of Tafamidis (PF-6291826) in the Blood

Study Overview
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Brief Summary
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2 different formulations and doses of tafamidis will be compared. All subjects will receive both doses/formulations. Subjects will take tafamidis for 7 days, on the first 2 days they will take tafamidis twice, 12 hours apart and then once a day for the next 5 days. Subjects will be fasted before taking the drug. Blood samples will be taken to measure the amount of tafamidis starting on day 7 and ending on day 8. At least 16 days after the first formulation/dose is given, all subjects will repeat the procedure with the other formulation/dose.

Official Title
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A Phase 1, Open-label, Randomized, Crossover, Multiple Dose, Pivotal Bioequivalence Study To Compare Pf-06291826 4 X 20 Mg Tafamidis Meglumine And 61 Mga Tafamidis Free Acid Soft Gelatin Capsules Administered Under Fasted Conditions To Healthy Volunteers

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 of females of non-childbearing potential Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb) 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. Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer) 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<br> | Drug: tafamidis<br>* bioequivalence study<br>|
| Experimental: 4x20 mg tafamidis meglumine soft gelatin capsule<br> | Drug: tafamidis<br>* bioequivalence 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 (AUC) |  | 24 hours | 
| maximum observed plasma concentration (Cmax) |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| minimum observed plasma concentration (Cmin) |  | 24 hours | 
| Time to maximum observed plasma concentration (Tmax) |  | 24 hours |