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

NCT07587697 | Recruiting Phase 1

• 1 other identifier: B3461128
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

Study Arms (6)

Test 1 tablet followed by Test 2 tablet followed by Reference capsule

EXPERIMENTAL

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

Test 2 tablet followed by Reference capsule followed by Test 1 tablet

EXPERIMENTAL

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 capsule followed by Test 1 tablet followed by Test 2 tablet

EXPERIMENTAL

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

Test 1 tablet followed by Reference capsule followed by Test 2 tablet

EXPERIMENTAL

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

Test 2 tablet followed by Test 1 tablet followed by Reference capsule

EXPERIMENTAL

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 capsule followed by Test 2 tablet followed by Test 1 tablet

EXPERIMENTAL

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

Interventions

Tafamidis DRUG

(Reference) 61 milligram (mg)free acid capsule

Reference capsule followed by Test 1 tablet followed by Test 2 tablet; Reference capsule followed by Test 2 tablet followed by Test 1 tablet; Test 1 tablet followed by Reference capsule followed by Test 2 tablet; Test 1 tablet followed by Test 2 tablet followed by Reference capsule; Test 2 tablet followed by Reference capsule followed by Test 1 tablet; Test 2 tablet followed by Test 1 tablet followed by Reference capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

P-One Clinic

Hachioji-shi, Tokyo, 1920071, Japan

RECRUITING

Related Links

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

MeSH Terms

Interventions

tafamidis

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 14, 2026
• Study Start: May 11, 2026
• Primary Completion (Estimated): August 3, 2026
• Study Completion (Estimated): August 3, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)