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

Study Overview
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Brief Summary
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This is a 2 part study. In part 1 of the study, 3 different formulations of the same dose of tafamidis will be compared. Subjects will be fasted for each test and every subject will test all 3 different formulations. After swallowing tafamidis, tafamidis blood concentrations will be measured periodically for 6 days. After 14 days, subjects will take a different formulation of tafamidis and tafamidis blood concentrations will be measured periodically for 6 days. After another 14 days, the last formulation will be tested in the same way. In part 2 of the study, depending on the results of part 1, either none, one or 2 of the formulations tested in part 1 will be tested comparing the same formulation when given either with or without food. Additionally, depending on the results of part 1 of the study, different doses of the formulations may be compared.

Official Title
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A Phase 1, Open-Label, Randomized, Single Dose Study To Estimate The Relative Bioavailability And Food Effect Of PF-06291826 (Tafamidis) Following Administration Of New Soft Gelatin Capsule Oral Formulations In Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* 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. 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: 4 soft gel capsules of 20 mg tafamidis meglumine<br> | Drug: tafamidis<br>* relative bioavailability<br>|
| Experimental: 48.8 mg tafamidis soft gel capsule formulation 1<br> | Drug: tafamidis<br>* relative bioavailability<br>Drug: tafamidis<br>* fed<br>|
| Experimental: 48.8 mg tafamidis soft get capsule formulation 2<br> | Drug: tafamidis<br>* relative bioavailability<br>Drug: tafamidis<br>* fed<br>|
| Experimental: 61 mg tafamidis soft gel capsule formulation 1<br> | Drug: tafamidis<br>* fasted<br>|
| Experimental: 61 mg tafamidis soft gel capsule formulation 2<br> | Drug: tafamidis<br>* fasted<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) |  | 120 hours | 
| Maximum Observed Plasma Concentration (Cmax) |  | 120 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |  | 120 hours | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | 120 hours | 
| Plasma Decay Half-Life (t1/2) |  | 120 hours | 
| Area Under the Curve from Time zero to infinity |  | 120 hours |