HealthyPhase 1NCT05482308

A Study to Compare Two Tablet Forms of Tafamidis in Healthy Participants

A Phase 1 study testing Tafamidis free acid tablet (Test) and Tafamidis free acid tablet (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 blood after taking two different tablet forms of tafamidis This study is seeking healthy participants over the age of 18. 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 free acid tablet (Test) and Tafamidis free acid tablet (Reference)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteBelgium
Study dates: 29 Aug 2022to 28 Oct 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

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, and laboratory tests.
Body Mass Index of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

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
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to COVID-19 pandemic (eg, Contact with positive case, residence, or travel to an area with high incidence) that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

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Prior/Concomitant Therapy:
Use of prescription or nonprescription drugs, dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention. (Refer to Section 6.9 Prior and Concomitant Therapy for additional details).
Current use of any prohibited concomitant medication(s) or participant unwilling/unable to use a permitted concomitant medication(s). Refer to Section 6.9 Prior and Concomitant Therapy.
Prior/Concurrent Clinical Study Experience:
Previous administration with 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.
Screening seated BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of seated rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), 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 the uncorrected QT interval is >450 ms, this interval should be rate-corrected using the Fridericia method only and the resulting QTcF should be used for decision making and reporting. 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.
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:
AST or ALT level ≥ 1.5 × ULN;
Total bilirubin level ≥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).
Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
History of sensitivity to heparin or heparin induced thrombocytopenia.
Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of the 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 STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF VARIANT 12.2 MG TAFAMIDIS FREE ACID TABLETS AND PROPOSED COMMERCIAL 12.2 MG TAFAMIDIS FREE ACID TABLETS ADMINISTERED UNDER FASTED CONDITIONS IN HEALTHY ADULT PARTICIPANTS

The purpose of this clinical trial is to compare the amount of tafamidis in blood after taking two different tablet forms of tafamidis

This study is seeking healthy participants over the age of 18.

All participants in the study will receive one tablet of study medicine on the first day, then receive one dose of the other tablet form 16 days later.

We will compare the amounts in blood for 8 days after taking each dose of the study medicine.

Participants will take part in this study for about 80 days. The first visit is a screening visit to ensure that participants are appropriate for the study. Up to 28 days later, they will visit the study clinic twice (and stay overnight in the clinical research center for 8 nights each time). The study team will also call participants over the phone 28 to 35 days after the last dose of medicine.

Conditions: Healthy
Being tested: Tafamidis free acid tablet (Test), Tafamidis free acid tablet (Reference)
Keywords: tafamidis

What participants receive

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

Tafamidis free acid tablet (Test)Drug
Variant 12.2 mg tafamidis free acid tablet (Test)
Tafamidis free acid tablet (Reference)Drug
Proposed commercial 12.2 mg tafamidis free acid tablet (Reference)

Study groups in NCT05482308
Study group	Role	What they receive
Test tablet followed by Reference 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 free acid tablet (Test); Drug: Tafamidis free acid tablet (Reference)
Reference tablet 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 Receives: Drug: Tafamidis free acid tablet (Test); Drug: Tafamidis free acid tablet (Reference)

What is being measured

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

Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Tafamidis (Both Variant 12.2 mg Tafamidis Free Acid Tablet and Proposed Commercial 12.2 mg Tafamidis Free Acid Tablet)
The AUCinf was determined by AUClast+ (Clast*/kel), where Clast* is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis; kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Measured: Days 1 (Pre-dose,0.5,1,2,3,4,6,8,12 hours post dose),2,3,4,5,6,7 and 8 in both Periods 1 and 2.
Maximum Plasma Concentration (Cmax) of Tafamidis (Both Variant 12.2 mg Tafamidis Free Acid Tablet and Proposed Commercial 12.2 mg Tafamidis Free Acid Tablet)
Cmax was observed directly from data.
Measured: Days 1 (Pre-dose,0.5,1,2,3,4,6,8,12 hours post dose),2,3,4,5,6,7 and 8 in both Periods 1 and 2.

Timeline

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

29 Aug 202228 Oct 2022

First posted1 Aug 2022
Study start29 Aug 2022
Primary completion28 Oct 2022
Study completion28 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies 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: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05482308
Sponsor's protocol ID: B3461102
Other IDs: 2022-001833-35
Status last verified: Apr 2024
First submitted: 28 Jul 2022
Last updated: 23 May 2024
Results posted: Yes, on ClinicalTrials.gov
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.

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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Study at a glance

From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, OPEN-LABEL, RANDOMIZED, CROSSOVER, SINGLE DOSE STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF VARIANT 12.2 MG TAFAMIDIS FREE ACID TABLETS AND PROPOSED COMMERCIAL 12.2 MG TAFAMIDIS FREE ACID TABLETS ADMINISTERED UNDER FASTED CONDITIONS IN HEALTHY ADULT PARTICIPANTS
ClinicalTrials.gov ID: NCT05482308
Acronym / sponsor ID: B3461102
Conditions: Healthy
Keywords: tafamidis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 29 Aug 2022 (actual)
Primary completion: 28 Oct 2022 (actual)
Study completion: 28 Oct 2022 (actual)
First posted: 1 Aug 2022 (actual)
Results: Posted 23 May 2024

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 amount of tafamidis in blood after taking two different tablet forms of tafamidis

This study is seeking healthy participants over the age of 18.

All participants in the study will receive one tablet of study medicine on the first day, then receive one dose of the other tablet form 16 days later.

We will compare the amounts in blood for 8 days after taking each dose of the study medicine.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Test tablet followed by Reference tablet	Experimental	Drug: Tafamidis free acid tablet (Test), Drug: Tafamidis free acid tablet (Reference)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.
Reference tablet followed by Test tablet	Experimental	Drug: Tafamidis free acid tablet (Test), Drug: Tafamidis free acid tablet (Reference)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

Who may qualify

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

Key inclusion criteria (3 listed)

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, and laboratory tests.
Body Mass Index of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

Key exclusion criteria (25 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).
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to COVID-19 pandemic (eg, Contact with positive case, residence, or travel to an area with high incidence) that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Use of prescription or nonprescription drugs, dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention. (Refer to Section 6.9 Prior and Concomitant Therapy for additional details).
Current use of any prohibited concomitant medication(s) or participant unwilling/unable to use a permitted concomitant medication(s). Refer to Section 6.9 Prior and Concomitant Therapy.
Previous administration with 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).

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 free acid tablet (Test)Variant 12.2 mg tafamidis free acid tablet (Test)	Drug	Reference tablet followed by Test tablet, Test tablet followed by Reference tablet
Tafamidis free acid tablet (Reference)Proposed commercial 12.2 mg tafamidis free acid tablet (Reference)	Drug	Reference tablet followed by Test tablet, Test tablet followed by Reference tablet

Primary outcome

Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Tafamidis (Both Variant 12.2 mg Tafamidis Free Acid Tablet and Proposed Commercial 12.2 mg Tafamidis Free Acid Tablet)
Time frame: Days 1 (Pre-dose,0.5,1,2,3,4,6,8,12 hours post dose),2,3,4,5,6,7 and 8 in both Periods 1 and 2.
The AUCinf was determined by AUClast+ (Clast*/kel), where Clast* is the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis; kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Maximum Plasma Concentration (Cmax) of Tafamidis (Both Variant 12.2 mg Tafamidis Free Acid Tablet and Proposed Commercial 12.2 mg Tafamidis Free Acid Tablet)
Time frame: Days 1 (Pre-dose,0.5,1,2,3,4,6,8,12 hours post dose),2,3,4,5,6,7 and 8 in both Periods 1 and 2.
Cmax was observed directly from data.

Results and safety

Results posted to the registry on 23 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Variant 12.2 mg Tafamidis Free Acid Tablet ->Proposed Commercial 12.2 mg Tafamidis Free Acid Tablet	6	5
Proposed Commercial 12.2 mg Tafamidis Free Acid Tablet ->Variant 12.2 mg Tafamidis Free Acid Tablet	6	5

Primary outcome: Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Tafamidis (Both Variant 12.2 mg Tafamidis Free Acid Tablet and Proposed Commercial 12.2 mg Tafamidis Free Acid Tablet)

Time frame: Days 1 (Pre-dose,0.5,1,2,3,4,6,8,12 hours post dose),2,3,4,5,6,7 and 8 in both Periods 1 and 2.. Geometric mean (Geometric Coefficient of Variation). Unit: hour(h)*ng/mL

Measure	Variant 12.2 mg Tafamidis Free Acid Tablet (Test) n = 11	Proposed Commercial 12.2 mg Tafamidis Free Acid Tablet (Reference) n = 12
Value	58630 (21)	57060 (25)

Variant 12.2 mg Tafamidis Free Acid Tablet (Test) vs Proposed Commercial 12.2 mg Tafamidis Free Acid Tablet (Reference): Mean differences(Test-Reference): 98.35 (90% CI 92.92 to 104.10), Mixed effect model

Population analysed: The PK parameter population was defined as all participants who received at least 1 dose of tafamidis and who had at least 1 of the PK parameters of interest calculated.

Primary outcome: Maximum Plasma Concentration (Cmax) of Tafamidis (Both Variant 12.2 mg Tafamidis Free Acid Tablet and Proposed Commercial 12.2 mg Tafamidis Free Acid Tablet)

Time frame: Days 1 (Pre-dose,0.5,1,2,3,4,6,8,12 hours post dose),2,3,4,5,6,7 and 8 in both Periods 1 and 2.. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Variant 12.2 mg Tafamidis Free Acid Tablet (Test)) n = 11	Proposed Commercial 12.2 mg Tafamidis Free Acid Tablet (Reference) n = 12
Value	875.2 (22)	926.5 (22)

Variant 12.2 mg Tafamidis Free Acid Tablet (Test)) vs Proposed Commercial 12.2 mg Tafamidis Free Acid Tablet (Reference): Mean difference (Test-Reference): 91.58 (90% CI 81.50 to 102.90), Mixed effect model

Population analysed: The PK concentration population was defined as all participants who receive dat least 1 dose of tafamidis and who had at least 1 measurable concentration of tafamidis.

Adverse events

Time frame: From informed consent through and including a minimum of 28 calendar days after last administration of study drug, up to 35 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Variant 12.2 mg Tafamidis Free Acid Tablet (Test))	0 of 11 (0%)	6 of 11 (54.5%)	0 of 11
Commercial 12.2 mg Tafamidis Free Acid Tablet (Reference)	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 free acid tablet (Test) and Tafamidis free acid tablet (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 3 inclusion and 25 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 23 May 2024. 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?

Yes. Results are posted in the registry (first posted 23 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Tafamidis (Both Variant 12.2 mg Tafamidis Free Acid Tablet and Proposed Commercial 12.2 mg Tafamidis Free Acid Tablet) (time frame: Days 1 (Pre-dose,0.5,1,2,3,4,6,8,12 hours post dose),2,3,4,5,6,7 and 8 in both Periods 1 and 2.). 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 NCT05482308.

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 23 May 2024.