A Study To Estimate How Much Tafamidis Created In Different Ways Can Be Measured in Blood Samples

A Phase 1, Open-Label, Randomized, 2-Cohort, Crossover, Single Dose Study to Estimate the Relative Bioavailability of PF 06291826 (Tafamidis) Following Administration of Two Oral Formulations Versus Commercial Capsule in Healthy Subjects Under Fasted Conditions

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02189330

Enrollment

Registered

2014-07-14

Start date

2014-05-31

Completion date

2014-07-31

Last updated

2014-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief summary

All subjects in this study will be given tafamidis. After swallowing a single pill of tafamidis, measurements including blood samples will be compared to see if tafamidis made in different ways is about the same. After approximately 28 days subjects will be given another pill of tafamidis and the study measurements will be repeated.

Interventions

DRUGTafamidis

20 mg of current commercial formulation.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]	168 hours	AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
Maximum Observed Plasma Concentration (Cmax)	168 hours	—

Secondary

Measure	Time frame	Description
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	168 hours	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time to Reach Maximum Observed Plasma Concentration (Tmax)	6	—

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026