A Study Comparing Amounts of Tafamidis In The Blood With Or Without Food
- Registration Number
- NCT02534740
- Lead Sponsor
- Pfizer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- 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).
- 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 48.8 mg tafamidis soft gel capsule formulation 1 tafamidis - 4 soft gel capsules of 20 mg tafamidis meglumine tafamidis - 48.8 mg tafamidis soft get capsule formulation 2 tafamidis - 61 mg tafamidis soft gel capsule formulation 1 tafamidis - 61 mg tafamidis soft gel capsule formulation 2 tafamidis -
- Primary Outcome Measures
Name Time Method Area under the concentration-time Curve (AUC) 120 hours Maximum Observed Plasma Concentration (Cmax) 120 hours
- Secondary Outcome Measures
Name Time Method Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) 120 hours Area Under the Curve from Time zero to infinity 120 hours Time to Reach Maximum Observed Plasma Concentration (Tmax) 120 hours Plasma Decay Half-Life (t1/2) 120 hours
Trial Locations
- Locations (1)
Pfizer Clinical Research Unit
🇧🇪Brussels, Belgium