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

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Pfizer

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: tafamidis

Study type

Interventional

Funder types

Industry

Identifiers

NCT02746926
B3461053

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

12 participants in 3 patient groups

4x20 mg tafamidis meglumine soft gel capsule
Experimental group
Treatment:
Drug: tafamidis
48.8 mgA tafamidis free acid capsule
Experimental group
Treatment:
Drug: tafamidis
61 mgA tafamidis free acid capsule
Experimental group
Treatment:
Drug: tafamidis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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