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

NCT07470866 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: B34611312026-525342-29-00
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Tafamidis

Outcome Measures

Primary Outcomes (2)

• Area under the concentration-time curve (AUCinf)

  Area under the plasma concentration time profile from time zero extrapolated to infinite time.

  Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168.

• Maximum observed plasma concentration (Cmax)

  Peak or maximum observed concentration.

  Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168

Secondary Outcomes (5)

• Number or percentage of patients with abnormal physical examination findings

  Baseline up to Day 53

• Number or percentage of patients with change from baseline in Clinical Laboratory parameters

  Baseline up to Day 25

• Number or percentage of patients with change from baseline in vital sign measurements

  Baseline up to Day 25

• Number of patients with change in electrocardiogram (ECG) parameters

  Baseline up to Day 25

• Incidence of adverse events

  Baseline up to Day 53 (35 days after last dose)

Study Arms (2)

Reference capsule followed by Test 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); Drug: Tafamidis (Test)

Test 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); Drug: Tafamidis (Test)

Interventions

Tafamidis (Reference) DRUG

61 milligrams (mg) free acid capsule

Reference capsule followed by Test tablet; Test tablet followed by Reference capsule

Tafamidis (Test) DRUG

61 mg free acid tablet

Reference capsule followed by Test tablet; Test 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:

• Age and Sex:
• years of age or older (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
• BMI of 16-32 kg/m2; and a total body weight \>45 kg (99 lb).
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

You may not qualify if:

• Medical Conditions:
• 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.
• Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• Prior/Concomitant Therapy:
• 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.
• Use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).
• Prior/Concurrent Clinical Study Experience:
• Previous administration of an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.
• Diagnostic Assessments:
• A positive urine drug test. A single repeat for positive drug screen may be allowed.
• Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic) for participants \<60 years; and ≥150/90 mm/Hg for participants ≥60 years old, following at least 5 minutes of supine rest. If systolic BP is ≥ 140 or 150 mm Hg (based on age) or diastolic ≥90 mm Hg, the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
• Renal impairment as defined by eGFR \<60 mL/min/1.73 m², which may be confirmed by a single repeat test, if necessary.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

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: March 10, 2026
• First Posted: March 13, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): June 2, 2026
• Study Completion (Estimated): June 2, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)