A Study to Compare the Amount of Two Forms of Tafamidis in the Blood of Healthy Adults Under Fasting Conditions

A PHASE 1, OPEN-LABEL, RANDOMIZED, THREE-TREATMENT, THREE-PERIOD, CROSSOVER, SINGLE DOSE, PIVOTAL BIOEQUIVALENCE STUDY TO COMPARE TAFAMIDIS FREE ACID ORALLY DISINTEGRATING TABLET AND COMMERCIAL TAFAMIDIS FREE ACID CAPSULE ADMINISTERED UNDER FASTED CONDITIONS IN HEALTHY ADULT PARTICIPANTS

The purpose of this clinical trial is to compare the blood tafamidis concentration of healthy adult participants after taking two different forms of tafamidis by under fasted conditions.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy Adults
• Intervention / Treatment: Drug: Tafamidis; Drug: Tafamidis; Drug: Tafamidis

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Hachioji-shi, Tokyo, Japan, 1920071
      • P-One Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Healthy female participants of nonchildbearing potential and/or male participants who are overtly healthy as determined by medical evaluation BMI of 16-32 kg/m2; and a total body weight >45 kg (99 lb).

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). Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy). History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, HBcAB or HCVAb. Hepatitis B vaccination is allowed. Hypersensitivity to any component of the formulations. Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test 1 tablet followed by Test 2 tablet followed by Reference capsule; On Day 1 of each period, participants will receive a single dose of 1 of the tafamidis formulations. Each period is separated by a washout of at least 16 days between administration of study drug	Drug: Tafamidis; (Reference) 61 milligram (mg)free acid capsule; Drug: Tafamidis; (Test 1) 61mg orally disintegrating tablet (ODT) with water; Drug: Tafamidis; (Test 2) 61mg ODT without water
Experimental: Test 1 tablet followed by Reference capsule followed by Test 2 tablet; On Day 1 of each period, participants will receive a single dose of 1 of the tafamidis formulations. Each period is separated by a washout of at least 16 days between administration of study drug	Drug: Tafamidis; (Reference) 61 milligram (mg)free acid capsule; Drug: Tafamidis; (Test 1) 61mg orally disintegrating tablet (ODT) with water; Drug: Tafamidis; (Test 2) 61mg ODT without water
Experimental: Test 2 tablet followed by Reference capsule followed by Test 1 tablet; On Day 1 of each period, participants will receive a single dose of 1 of the tafamidis formulations. Each period is separated by a washout of at least 16 days between administration of study drug	Drug: Tafamidis; (Reference) 61 milligram (mg)free acid capsule; Drug: Tafamidis; (Test 1) 61mg orally disintegrating tablet (ODT) with water; Drug: Tafamidis; (Test 2) 61mg ODT without water
Experimental: Test 2 tablet followed by Test 1 tablet followed by Reference capsule; On Day 1 of each period, participants will receive a single dose of 1 of the tafamidis formulations. Each period is separated by a washout of at least 16 days between administration of study drug	Drug: Tafamidis; (Reference) 61 milligram (mg)free acid capsule; Drug: Tafamidis; (Test 1) 61mg orally disintegrating tablet (ODT) with water; Drug: Tafamidis; (Test 2) 61mg ODT without water
Experimental: Reference capsule followed by Test 1 tablet followed by Test 2 tablet; On Day 1 of each period, participants will receive a single dose of 1 of the tafamidis formulations. Each period is separated by a washout of at least 16 days between administration of study drug	Drug: Tafamidis; (Reference) 61 milligram (mg)free acid capsule; Drug: Tafamidis; (Test 1) 61mg orally disintegrating tablet (ODT) with water; Drug: Tafamidis; (Test 2) 61mg ODT without water
Experimental: Reference capsule followed by Test 2 tablet followed by Test 1 tablet; On Day 1 of each period, participants will receive a single dose of 1 of the tafamidis formulations. Each period is separated by a washout of at least 16 days between administration of study drug	Drug: Tafamidis; (Reference) 61 milligram (mg)free acid capsule; Drug: Tafamidis; (Test 1) 61mg orally disintegrating tablet (ODT) with water; Drug: Tafamidis; (Test 2) 61mg ODT without water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of tafamidis	Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose
Maximum Observed Plasma Concentration (Cmax)of tafamidis.	Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma concentration-time curve from time zero to 72 hours(AUC72)	Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours
Time to reach Cmax (Tmax)	Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours
Area under the plasma concentration-time curve from time zero to infinity (AUCinf) if data permit	Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours
Terminal phase rate constant (kel) if data permit	Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours
terminal phase half-life (t½) if data permit	Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours
Number of participants with treatment emergent adverse events(TEAE)	Day 1 of dosing up to approximately 5 weeks after last dose (up to maximum of approximately 5 weeks)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2026
• Primary Completion (Estimated): August 3, 2026
• Study Completion (Estimated): August 3, 2026

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: May 8, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: tafamidis
• Other Study ID Numbers: B3461128

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No