HealthyPhase 1NCT05498701

A Study Comparing Two Forms of Tafamidis Without Food and the Amount of Tafamidis in the Blood With Food

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

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 a tablet and a capsule form of tafamidis without food and to assess the amount of tafamidis in blood after taking the tablet form with food. 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 meglumine 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 siteCanada
Study dates: 29 Sep 2022to 19 Dec 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.
BMI 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 6 months (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 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.

Canada1 site

Pharma Medica Research Inc
Toronto, Ontario, M1S 3V6

Other trials in Canada

About this study

Official title: A PHASE 1, OPEN-LABEL, RANDOMIZED, CROSSOVER, SINGLE DOSE STUDY TO DETERMINE THE BIOEQUIVALENCE OF 12.2 MG TAFAMIDIS FREE ACID TABLETS AND COMMERCIAL 20 MG TAFAMIDIS MEGLUMINE CAPSULES ADMINISTERED UNDER FASTED CONDITIONS AND THE EFFECT OF FOOD ON ORAL BIOAVAILABILITY OF 12.2 MG TAFAMIDIS FREE ACID TABLETS IN HEALTHY ADULT PARTICIPANTS

The purpose of this clinical trial is to compare a tablet and a capsule form of tafamidis without food and to assess the amount of tafamidis in blood after taking the tablet form with food.

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

All participants in the study will receive either one tablet or capsule of study medicine on the first day without food, then receive one dose of the other tablet or capsule form 16 days later without food. All participants will then receive one dose of the tablet form with food 16 days later.

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

Participants will take part in this study for about 96 days. The first visit is a screening visit to ensure that participants are appropriate for the study. Up to 28 days later, eligible participants will visit the study clinic three times (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 meglumine capsule (Reference)
Keywords: Tafamidis, B3461103

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
12.2 mg tafamidis free acid tablet (Test)
Tafamidis meglumine capsule (Reference)Drug
Commercial 20 mg tafamidis meglumine capsule (Reference)

Study groups in NCT05498701
Study group	Role	What they receive
Test tablet (fasted) followed by Reference capsule (fasted) followed by Test tablet (fed)	Experimental	On Day 1 of each period, participants will receive a single dose of one of the tafamidis formulations under fasted or fed conditions. 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 meglumine capsule (Reference)
Reference capsule (fasted) followed by Test tablet (fasted) followed by Test tablet (fed)	Experimental	On Day 1 of each period, participants will receive a single dose of one of the tafamidis formulations under fasted or fed conditions. 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 meglumine capsule (Reference)

What is being measured

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

Pharmacokinetics(PK) Parameter - Area Under the Concentration-time Curve to Infinity (AUCinf) of PF-06291826
AUCinf is defined as area under the concentration-time curve from time 0 to infinity, and calculated by AUC(0-tlast) + (Clast*/kel), where Clast* is the estimated plasma concentration at the last quantifiable time point (Clast) estimated form the log-linear regression analysis Clast* = Clast x e^(-kel x tlast)
Measured: Predose and 0.5, 1,2,3,4,6,8,12,24 (Day 2),48 (Day 3),72 (Day 4),96 (Day 5),120 (Day 6),144 (Day 7), and 168 (Day 8) hours post dose
PK Parameter - Maximum Observed Concentration (Cmax) of PF-06291826
Cmax is defined as maximum observed concentration.
Measured: Predose and 0.5, 1,2,3,4,6,8,12,24 (Day 2),48 (Day 3),72 (Day 4),96 (Day 5),120 (Day 6),144 (Day 7), and 168 (Day 8) hours post dose

Timeline

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

29 Sep 202219 Dec 2022

First posted12 Aug 2022
Study start29 Sep 2022
Primary completion18 Dec 2022
Study completion19 Dec 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: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05498701
Sponsor's protocol ID: B3461103
Status last verified: May 2024
First submitted: 10 Aug 2022
Last updated: 3 Jun 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?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 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 DETERMINE THE BIOEQUIVALENCE OF 12.2 MG TAFAMIDIS FREE ACID TABLETS AND COMMERCIAL 20 MG TAFAMIDIS MEGLUMINE CAPSULES ADMINISTERED UNDER FASTED CONDITIONS AND THE EFFECT OF FOOD ON ORAL BIOAVAILABILITY OF 12.2 MG TAFAMIDIS FREE ACID TABLETS IN HEALTHY ADULT PARTICIPANTS
ClinicalTrials.gov ID: NCT05498701
Acronym / sponsor ID: B3461103
Conditions: Healthy
Keywords: Tafamidis, B3461103
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 29 Sep 2022 (actual)
Primary completion: 18 Dec 2022 (actual)
Study completion: 19 Dec 2022 (actual)
First posted: 12 Aug 2022 (actual)
Results: Posted 3 Jun 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 a tablet and a capsule form of tafamidis without food and to assess the amount of tafamidis in blood after taking the tablet form with food.

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

We will evaluate 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 (fasted) followed by Reference capsule (fasted) followed by Test tablet (fed)	Experimental	Drug: Tafamidis free acid tablet (Test), Drug: Tafamidis meglumine capsule (Reference)On Day 1 of each period, participants will receive a single dose of one of the tafamidis formulations under fasted or fed conditions. Each period is separated by a washout of at least 16 days between administration of study drug.
Reference capsule (fasted) followed by Test tablet (fasted) followed by Test tablet (fed)	Experimental	Drug: Tafamidis free acid tablet (Test), Drug: Tafamidis meglumine capsule (Reference)On Day 1 of each period, participants will receive a single dose of one of the tafamidis formulations under fasted or fed conditions. 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.
BMI 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 6 months (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)12.2 mg tafamidis free acid tablet (Test)	Drug	Reference capsule (fasted) followed by Test tablet (fasted) followed by Test tablet (fed), Test tablet (fasted) followed by Reference capsule (fasted) followed by Test tablet (fed)
Tafamidis meglumine capsule (Reference)Commercial 20 mg tafamidis meglumine capsule (Reference)	Drug	Reference capsule (fasted) followed by Test tablet (fasted) followed by Test tablet (fed), Test tablet (fasted) followed by Reference capsule (fasted) followed by Test tablet (fed)

Primary outcome

Pharmacokinetics(PK) Parameter - Area Under the Concentration-time Curve to Infinity (AUCinf) of PF-06291826
Time frame: Predose and 0.5, 1,2,3,4,6,8,12,24 (Day 2),48 (Day 3),72 (Day 4),96 (Day 5),120 (Day 6),144 (Day 7), and 168 (Day 8) hours post dose
AUCinf is defined as area under the concentration-time curve from time 0 to infinity, and calculated by AUC(0-tlast) + (Clast*/kel), where Clast* is the estimated plasma concentration at the last quantifiable time point (Clast) estimated form the log-linear regression analysis Clast* = Clast x e^(-kel x tlast)
PK Parameter - Maximum Observed Concentration (Cmax) of PF-06291826
Time frame: Predose and 0.5, 1,2,3,4,6,8,12,24 (Day 2),48 (Day 3),72 (Day 4),96 (Day 5),120 (Day 6),144 (Day 7), and 168 (Day 8) hours post dose
Cmax is defined as maximum observed concentration.

Results and safety

Results posted to the registry on 3 Jun 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
Sequence 1	11	11
Sequence 2	11	11

Primary outcome: Pharmacokinetics(PK) Parameter - Area Under the Concentration-time Curve to Infinity (AUCinf) of PF-06291826

Time frame: Predose and 0.5, 1,2,3,4,6,8,12,24 (Day 2),48 (Day 3),72 (Day 4),96 (Day 5),120 (Day 6),144 (Day 7), and 168 (Day 8) hours post dose. Geometric mean (Geometric Coefficient of Variation). Unit: Nanograms * hour per milliliter

Measure	Tafamidis Free Acid 12.2 mg Oral Tablet (Fasted) n = 16	Tafamidis Meglumine 20 mg Oral Capsule (Fasted) n = 18	Tafamidis Free Acid 12.2 mg Oral Tablet (Fed) n = 17
Value	60670 (24)	67690 (22)	60210 (28)

Tafamidis Free Acid 12.2 mg Oral Tablet (Fasted) vs Tafamidis Meglumine 20 mg Oral Capsule (Fasted): Ratios of Adjusted Geometric Means: 93.19 (90% CI 87.10 to 99.70)

Population analysed: All participants who received at least 1 dose of tafamidis and who had at least 1 of the PK parameters of interest calculated. Here "Number of Participants Analyzed" signifies participants who contributing to this outcome measure.

Primary outcome: PK Parameter - Maximum Observed Concentration (Cmax) of PF-06291826

Measure	Tafamidis Free Acid 12.2 mg Oral Tablet (Fasted) n = 16	Tafamidis Meglumine 20 mg Oral Capsule (Fasted) n = 18	Tafamidis Free Acid 12.2 mg Oral Tablet (Fed) n = 17
Value	1046 (19)	1291 (21)	891.2 (18)

Tafamidis Free Acid 12.2 mg Oral Tablet (Fasted) vs Tafamidis Meglumine 20 mg Oral Capsule (Fasted): Ratio of Adjusted Geometric Means: 81.00 (90% CI 76.25 to 86.04)

Adverse events

Time frame: The time period for collecting AEs for each participant begins from the time the participant provided informed consent up to 35 days after administration of the final dose of study intervention (approximately 11 weeks).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tafamidis Free Acid 12.2 mg Oral Tablet (Fasted)	0 of 22 (0%)	4 of 22 (18.2%)	0 of 22
Tafamidis Meglumine 20 mg Oral Capsule (Fasted)	0 of 22 (0%)	2 of 22 (9.1%)	0 of 22
Tafamidis Free Acid 12.2 mg Oral Tablet (Fed)	0 of 21 (0%)	4 of 21 (19%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 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 meglumine capsule (Reference) in people with Healthy, run by Pfizer at 1 site in Canada.

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 3 Jun 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 Canada. 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 3 Jun 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?

Pharmacokinetics(PK) Parameter - Area Under the Concentration-time Curve to Infinity (AUCinf) of PF-06291826 (time frame: Predose and 0.5, 1,2,3,4,6,8,12,24 (Day 2),48 (Day 3),72 (Day 4),96 (Day 5),120 (Day 6),144 (Day 7), and 168 (Day 8) 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 NCT05498701.

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 3 Jun 2024.