A Study Comparing the Amounts of 2 Different Forms of Tafamidis (PF06291826), Both With and Without Food, In the Blood
- Registration Number
- NCT03280173
- Lead Sponsor
- Pfizer
- Brief Summary
2 different formulations of tafamidis will be compared under both fed and fasted conditions. Subjects will be fasted overnight or fed. After swallowing one of the tafamidis formulations, tafamidis blood concentrations will be measured periodically for 8 days. After 16 days, subjects will take a different formulation in the fed or fasted state or take the same formulation in the opposite feeding condition. This will be repeated, 16 days apart, until all subjects have taken each formulation both fed and fasted.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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 61 mgA tafamidis free acid soft gelatin capsule fed tafamidis fasted 61 mgA tafamidis free acid soft gelatin capsule fasted tafamidis fed 4 × 20 mg tafamidis meglumine soft gelatin capsules fed tafamidis fed 4 × 20 mg tafamidis meglumine soft gelatin capsules fasted tafamidis fasted
- Primary Outcome Measures
Name Time Method Area under the concentration-time curve 0-72 hours (AUC72) 72 hrs maximum observed plasma concentration (Cmax) 168 hrs
- Secondary Outcome Measures
Name Time Method Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) 168 hrs Mean residence time (MRT) 168 hrs Time to Reach Maximum Observed Plasma Concentration (Tmax) 168 hrs Plasma Decay Half-Life (t1/2) 168 hrs Area under the curve from zero to infinity (AUCinf) 168 hrs
Trial Locations
- Locations (1)
Pfizer Clinical Research Unit
🇧🇪Brussels, Belgium