A Study Comparing Amounts of Tafamidis (PF‑06291826) in the Blood Without Food in Healthy Volunteers



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:9/30/2017
Start Date:April 29, 2016
End Date:July 15, 2016

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 1, Open‑Label, Three‑Period Randomized, Single Dose Study To Estimate The Relative Bioavailability Of Pf‑06291826 (Tafamidis) Free Acid Capsule Formulation Versus Commercial Capsule In Healthy Subjects Under Fasted Conditions

3 different formulations and doses 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 8 days. After 14
days, subjects will take a different formulation of tafamidis and tafamidis blood
concentrations will be measured periodically for 8 days. After another 14 days, the last
formulation will be tested in the same way.


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.
We found this trial at
1
site
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut 06511
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mi
from
New Haven, CT
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