A Study Comparing Amounts of 2 Different Forms of Tafamidis (PF-6291826) in the Blood

Pfizer

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: tafamidis

Study type

Interventional

Funder types

Industry

Identifiers

NCT03266705

2017-002572-15 (EudraCT Number)

B3461056

Details and patient eligibility

About

2 different formulations and doses of tafamidis will be compared. All subjects will receive both doses/formulations. Subjects will take tafamidis for 7 days, on the first 2 days they will take tafamidis twice, 12 hours apart and then once a day for the next 5 days. Subjects will be fasted before taking the drug. Blood samples will be taken to measure the amount of tafamidis starting on day 7 and ending on day 8. At least 16 days after the first formulation/dose is given, all subjects will repeat the procedure with the other formulation/dose.

Enrollment

30 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy males of females of non-childbearing potential
Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)

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.
Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer)
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.