Healthy Volunteers
Conditions
Brief summary
Each subject will be given tafamidis after either a high fat meal or while fasted. After swallowing tafamidis, tafamidis blood concentrations will be measured periodically for one week. After about 14 days, subjects will take either a different dose of tafamidis or the same dose under the opposite meal condition. Tafamidis concentrations from the three different conditions will be compared to determine if they are approximately the same.
Interventions
DRUGtafamidis
fasted
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the Concentration-Time Curve (AUC) | 168 hours | AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. |
| Maximum Observed Plasma Concentration (Cmax) | 168 hours | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 168 hours | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 168 hours | — |
| Plasma Decay Half-Life (t1/2) | 168 hours | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. |
Countries
Belgium
Outcome results
None listed