A Study Comparing Amounts of Tafamidis (PF-06291826) in the Blood Without Food in Healthy Volunteers
- Registration Number
- NCT02746926
- Lead Sponsor
- Pfizer
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 4x20 mg tafamidis meglumine soft gel capsule tafamidis - 61 mgA tafamidis free acid capsule tafamidis - 48.8 mgA tafamidis free acid capsule tafamidis -
- Primary Outcome Measures
Name Time Method Area under the concentration-time Curve (AUC) 168 hours Maximum Observed Plasma Concentration (Cmax) 168 hours
- Secondary Outcome Measures
Name Time Method Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) 168 hours Mean residence time (MRT) 168 hours Time to Reach Maximum Observed Plasma Concentration (Tmax) 168 hours Plasma Decay Half-Life (t1/2) 168 hours
Trial Locations
- Locations (1)
Pfizer New Haven Clinical Research Unit
🇺🇸New Haven, Connecticut, United States
Pfizer New Haven Clinical Research Unit🇺🇸New Haven, Connecticut, United States