Healthy AdultsPhase 1NCT07587697

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

A Phase 1 study testing Tafamidis in people with Healthy Adults, run by Pfizer at 1 site in Japan.

Completed

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

Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy Adults
What is being tested?: Tafamidis
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteJapan
Study dates: 11 May 2026to 3 Aug 2026
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

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Japan1 site

P-One Clinic
Hachioji-shi, Tokyo, 1920071

Other trials in Japan

About this study

Official title: 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.

Conditions: Healthy Adults
Being tested: Tafamidis

What participants receive

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

TafamidisDrug
(Reference) 61 milligram (mg)free acid capsule
TafamidisDrug
(Test 1) 61mg orally disintegrating tablet (ODT) with water
TafamidisDrug
(Test 2) 61mg ODT without water

Study groups in NCT07587697
Study group	Role	What they receive
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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Tafamidis
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 Receives: Drug: Tafamidis

What is being measured

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

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of tafamidis
Measured: 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.
Measured: 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)
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours
Time to reach Cmax (Tmax)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: Day 1 of dosing up to approximately 5 weeks after last dose (up to maximum of approximately 5 weeks)

Timeline

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

11 May 20263 Aug 2026

First posted14 May 2026
Study start11 May 2026
Primary completion3 Aug 2026
Study completion3 Aug 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy AdultsStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07587697
Sponsor's protocol ID: B3461128
Status last verified: Aug 2026
First submitted: 8 May 2026
Last updated: 31 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Adults trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07587697
Acronym / sponsor ID: B3461128
Conditions: Healthy Adults
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 11 May 2026 (actual)
Primary completion: 3 Aug 2026 (actual)
Study completion: 3 Aug 2026 (actual)
First posted: 14 May 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Test 1 tablet followed by Reference capsule followed by Test 2 tablet	Experimental	Drug: TafamidisOn 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
Reference capsule followed by Test 1 tablet followed by Test 2 tablet	Experimental	Drug: TafamidisOn 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
Test 2 tablet followed by Test 1 tablet followed by Reference capsule	Experimental	Drug: TafamidisOn 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
Test 2 tablet followed by Reference capsule followed by Test 1 tablet	Experimental	Drug: TafamidisOn 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
Reference capsule followed by Test 2 tablet followed by Test 1 tablet	Experimental	Drug: TafamidisOn 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
Test 1 tablet followed by Test 2 tablet followed by Reference capsule	Experimental	Drug: TafamidisOn 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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).

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tafamidis(Reference) 61 milligram (mg)free acid capsule	Drug	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
Tafamidis(Test 1) 61mg orally disintegrating tablet (ODT) with water	Drug	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
Tafamidis(Test 2) 61mg ODT without water	Drug	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

Primary outcome

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

6 secondary outcomes

Area under the plasma concentration-time curve from time zero to 72 hours(AUC72)
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours
Time to reach Cmax (Tmax)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Day 1 of dosing up to approximately 5 weeks after last dose (up to maximum of approximately 5 weeks)

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tafamidis in people with Healthy Adults, run by Pfizer at 1 site in Japan.

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 1 inclusion and 1 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 31 Aug 2026. 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 Japan. 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 Curve From Time Zero to Last Quantifiable Concentration (AUClast) of tafamidis (time frame: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168 hours post dose). 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 NCT07587697.

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 31 Aug 2026.