Phase I Safety, Pharmacokinetics and Bioavailability Study Comparing Rate and Extent of Absorption of Two Different Forms of Tafamidis (PF-6291826)

A PHASE 1, OPEN-LABEL, RANDOMIZED, THREE-PERIOD, THREE-SEQUENCE, SINGLE-DOSE, CROSSOVER STUDY IN FASTED HEALTHY SUBJECTS, TO ASSESS THE SAFETY, PHARMACOKINETICS AND ORAL BIOAVAILABILITY OF TAFAMIDIS FREE ACID WET-MILLED SUSPENSION DOSES, RELATIVE TO 4 X 20 MG COMMERCIAL TAFAMIDIS MEGLUMINE CAPSULES

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03662191

Enrollment

Registered

2018-09-07

Start date

2018-09-28

Completion date

2019-01-10

Last updated

2019-02-11

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

Conditions

Healthy Volunteers

Brief summary

2 different formulations and 4 different single doses of tafamidis will be compared. All subjects will receive both formulations and 3 different doses. Subjects will be fasted before taking the drug. After swallowing single dose of tafamidis, tafamidis blood concentrations will be measured periodically for 8 days. After another 16 days, all subjects will repeat the procedure twice, each time with the other formulation/dose.

Interventions

DRUGTafamidis

bioavailability study

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

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). * 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 the study. * Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.

Design outcomes

Primary

Measure	Time frame
1. Area under the plasma concentration-time profile from time 0 extrapolated to infinite time (AUCinf)	0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hrs
2. Maximum Observed Plasma Concentration (Cmax)	0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hrs

Secondary

Measure	Time frame
1. Area under the plasma concentration-time profile from time 0 to 24 hours post-dose (AUC24)	0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hrs
2. Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast)	0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hrs
3. Time to Reach Maximum Observed Plasma Concentration (Tmax)	0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hrs

Countries

Belgium

Outcome results

None listed

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