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HealthyPhase 1NCT06705569

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

A Phase 1 study testing Tafamidis 61 mg free acid tablet (Test) and Tafamidis 61 mg free acid capsule (Reference) in people with Healthy, run by Pfizer at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Tafamidis 61 mg free acid tablet (Test) and Tafamidis 61 mg free acid capsule (Reference)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteBelgium
Study dates
20 Dec 2024to 4 Apr 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • Other Inclusion Criteria:
  • 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.

Who cannot join

  • 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.
Show all 23Show fewer
  • 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.
  • Renal impairment as defined by an eGFR of <60 mL/min/1.73 m².
  • Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:
  • ALT, AST, Bilirubin ≥1.5 × ULN. Participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ULN.
  • Other Exclusion Criteria:
  • History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit, or 3 ounces (90 mL) of wine).
  • Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
  • Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
  • Use of tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Pfizer Clinical Research Unit - Brussels

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

Other trials in Belgium

About this study

Official title: A PHASE 1, OPEN-LABEL, RANDOMIZED, CROSSOVER, SINGLE DOSE, PIVOTAL BIOEQUIVALENCE STUDY TO COMPARE TAFAMIDIS FREE ACID 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 amount of tafamidis in the blood of healthy adult participants after taking two different forms of tafamidis by mouth.

Read the detailed description

A new tafamidis free acid tablet is being developed to be bioequivalent to the current commercial 61 mg tafamidis free acid capsule. The purpose of the study is to establish the bioequivalence of 61 mg tafamidis free acid tablet (Test) to 61 mg tafamidis free acid capsule (Reference, the clinical supply form of the current commercial 61 mg tafamidis free acid capsule) administered under fasted conditions in healthy adult participants.

Conditions
Healthy
Being tested
Tafamidis 61 mg free acid tablet (Test), Tafamidis 61 mg free acid capsule (Reference)
Keywords
tafamidis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tafamidis 61 mg free acid tablet (Test)Drug

    Tafamidis 61 mg free acid tablet (Test)

  • Tafamidis 61 mg free acid capsule (Reference)Drug

    Tafamidis 61 mg free acid capsule (Reference)

Study groups in NCT06705569
Study groupRoleWhat they receive
Test tablet followed by Reference capsuleExperimentalOn 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
Receives: Drug: Tafamidis 61 mg free acid tablet (Test); Drug: Tafamidis 61 mg free acid capsule (Reference)
Reference capsule followed by Test tabletExperimentalOn 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
Receives: Drug: Tafamidis 61 mg free acid tablet (Test); Drug: Tafamidis 61 mg free acid capsule (Reference)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the concentration-time curve (AUCinf)

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

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

  2. Maximum observed plasma concentration (Cmax)

    Peak or maximum observed concentration

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

Secondary outcomes (5)

  1. Number or percentage of patients with abnormal physical examination findings

    Assessment of abnormal physical examination findings during study participation

    Measured: Baseline up to Day 25

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

    Change in clinical laboratory parameters

    Measured: Baseline up to Day 25

  3. Number or percentage of patients with change from baseline in Vital sign measurements

    Change in vital sign measurements

    Measured: Baseline up to Day 25

  4. Number of patients with change in ECG parameters

    Change in ECG parameters

    Measured: Baseline up to Day 25

  5. Incidence of adverse events

    Assessment of adverse events during study participation and up to 35 days after last dose

    Measured: Baseline up to Day 53

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2024
  2. Study start20 Dec 2024
  3. Primary completion4 Apr 2025
  4. Study completion4 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06705569
Sponsor's protocol ID
B3461115
Other IDs
2024-514166-40-00
Status last verified
May 2025
First submitted
22 Nov 2024
Last updated
28 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tafamidis 61 mg free acid tablet (Test) and Tafamidis 61 mg free acid capsule (Reference) in people with Healthy, run by Pfizer at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the concentration-time curve (AUCinf) (time frame: Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06705569.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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