A Study Comparing Amounts of Tafamidis In The Blood Without Food
A Phase 1, Open-Label, Three Period Randomized, Single Dose Study To Estimate The Relative Bioavailability Of Pf-06291826 (Tafamidis) Free Acid Tablet Formulation Versus Commercial Capsule In Healthy Subjects Under Fasted Conditions
2 other identifiers
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Apr 2016
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 29, 2016
CompletedFirst Posted
Study publicly available on registry
March 3, 2016
CompletedStudy Start
First participant enrolled
April 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJuly 24, 2017
July 1, 2017
2 months
February 29, 2016
July 20, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Area under the concentration-time Curve (AUC)
120 hours
Maximum Observed Plasma Concentration (Cmax)
120 hours
Secondary Outcomes (4)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
120 hours
Mean residence time (MRT)
120 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)
120 hours
Plasma Decay Half-Life (t1/2)
120 hours
Study Arms (3)
48.8 mgA tafamidis free acid tablet
EXPERIMENTAL58 mgA tafamidis free acid tablet
EXPERIMENTAL4 soft gel capsules of 20 mg tafamidis meglumine
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Clinical Research Unit
Brussels, B-1070, Belgium
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 29, 2016
First Posted
March 3, 2016
Study Start
April 1, 2016
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
July 24, 2017
Record last verified: 2017-07