drugset / Trial / NCT02534740

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

NCT02534740

Phase 1 Completed 18 enrolled Pfizer
RandomizedCrossoverOpen-labelBasic science

Summary

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.

Timeline

Start
2015-09
Primary completion
2015-12
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Tafamidis Unknown 48.8 mg Oral
Subject Tafamidis Unknown 61 mg Oral
Subject Tafamidis Unknown 80 mg Oral

Indications

No indication recorded.