A Study to Compare Two Forms of Study Medicine Tafamidis in the Blood in Healthy Adults

NCT06705569 | Completed Phase 1 FDA Drug

• 2 other identifiers: B34611152024-514166-40-00
• Study Type: interventional
• Target: 22
• 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.

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 25

• 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 ECG parameters

  Baseline up to Day 25

• Incidence of adverse events

  Baseline up to Day 53

Study Arms (2)

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 61 mg free acid tablet (Test); Drug: Tafamidis 61 mg free acid capsule (Reference)

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 61 mg free acid tablet (Test); Drug: Tafamidis 61 mg free acid capsule (Reference)

Interventions

Tafamidis 61 mg free acid tablet (Test) DRUG

Tafamidis 61 mg free acid tablet (Test)

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

Tafamidis 61 mg free acid capsule (Reference) DRUG

Tafamidis 61 mg free acid capsule (Reference)

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:
• Participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at screening.
• Healthy female participants of nonchildbearing potential and/or male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination including blood pressure, pulse rate and standard 12 lead ECG, and laboratory tests.
• 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 recent (within the past year) or active suicidal ideation/behavior 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.
• Current use of any prohibited concomitant medication(s) or participant unwilling or unable 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 as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
• 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.
• Standard 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, QTcF \>450 ms, complete LBBB, signs of an acute or indeterminate age myocardial infarction, ST T interval changes suggestive of myocardial ischemia, second or third degree AV block, or serious bradyarrhythmias or tachyarrhythmias). If QTcF exceeds 450 ms, or QRS exceeds 120 ms, the ECG should be repeated twice and the average of the 3 QTcF or QRS values used to determine the participant's eligibility. Computer-interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding a participant.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - Brussels

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

Location

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

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: November 22, 2024
• First Posted: November 26, 2024
• Study Start: December 20, 2024
• Primary Completion: April 4, 2025
• Study Completion: April 4, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)