Safety and Efficacy of Tafamidis in Patients With Transthyretin Cardiomyopathy
Completed
Pfizer
Phase 3
2013-12-09
This Phase 3 study will investigate the efficacy, safety and tolerability of an oral daily
dose of 20 mg or 80 mg tafamidis meglumine capsules compared to placebo in subjects with
either transthyretin genetic variants or wild-type transthyretin resulting in amyloid
cardiomyopathy.
A Study Comparing Amounts of 2 Different Forms of Tafamidis (PF-6291826) in the Blood
Completed
Pfizer
Phase 1
2017-09-20
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.
A Study Comparing the Amounts of 2 Different Forms of Tafamidis (PF06291826), Both With and Without Food, In the Blood
Completed
Pfizer
Phase 1
2017-09-29
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.
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