Healthy
Conditions
Brief summary
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 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.
Interventions
DRUGtafamidis
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration-time Curve (AUC) | 120 hours |
| Maximum Observed Plasma Concentration (Cmax) | 120 hours |
Secondary
| Measure | Time frame |
|---|---|
| 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 Last Quantifiable Concentration (AUClast) | 120 hours |
| Mean residence time (MRT) | 120 hours |
Countries
Belgium
Outcome results
None listed