A Study Comparing Amounts of Tafamidis (PF-06291826) in the Blood Without Food in Healthy Volunteers

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT02746926

Run by

Pfizer

People needed

12

Starts

2016-04-29

Expected to finish

2016-07-15

Last updated by the study team

2017-09-28

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Pfizer New Haven Clinical Research Unit — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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