HealthyPhase 1NCT05767905

A Study to Understand the Effect of Tablet Formulation and Food on PF-06821497 in Healthy Adult Participants.

A Phase 1 study testing PF-06821497 Treatment A, PF-06821497 Treatment B and PF-06821497 Treatment C in people with Healthy, run by Pfizer at 1 site in United States.

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 study is to understand the effect of tablet formulation and presence of food on the study medicine PF-06821497 in healthy adult participants. The study is seeking for male and female participants who: Are 18 years of age or more. 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?: PF-06821497 Treatment A, PF-06821497 Treatment B and PF-06821497 Treatment C
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 17 Mar 2023to 20 Jun 2023
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 ≥18 years of age, inclusive, at screening.
Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs.
BMI of ≥17.5 kg/m2; and a total body weight >50 kg (110 lb)
Evidence of a personally signed and dated ICD indicating that the participant has been informed of all pertinent aspects of the study.
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

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) or prior allergic reaction to any component of PF-06821497.
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 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 and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
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).

Trial locations and contacts

1 site in 1 country.

United States1 site

New Haven Clinical Research Unit
New Haven, Connecticut, 06511

Other trials in United States

About this study

Official title: A PHASE 1, RANDOMIZED, OPEN-LABEL, 3-PERIOD, CROSSOVER, SINGLE-DOSE, 2-PART STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE EFFECT OF TABLET FORMULATION AND FOOD ON THE RELATIVE BIOAVAILABILITY OF PF-06821497

The purpose of this study is to understand the effect of tablet formulation and presence of food on the study medicine PF-06821497 in healthy adult participants.

The study is seeking for male and female participants who:

Are 18 years of age or more.
Are confirmed to be healthy after performing some medical and physical tests.
Weigh more than 50kgs of body weight and have a body mass index of 17 and a half kg per meter squared or more.

The study consists of two parts. In each part of the study, the selected participants will take part in 3 study periods to receive 3 different treatments which are randomly assigned. There will also be a 5-day gap between each study period. This is done so that the medicine is passed out of the body before the start of next study period.

Each treatment consists of a single dose of PF-06821497. The treatments differ by tablet formulation and/or whether the medicine is to be given with food or without food conditions.

How the medicine is processed in the body will be studied after giving the medicines to the participants. This will be done by collecting blood samples after each administration. The results will be used to see the effect of tablet formulation and presence of food on the amount of PF-06821497 available in the blood of the participants.

In each part, participants will be on the study up to 10 weeks, including the screening and follow-up periods.

Conditions: Healthy
Being tested: PF-06821497 Treatment A, PF-06821497 Treatment B, PF-06821497 Treatment C, PF-06821497 Treatment D, PF-06821497 Treatment E
Keywords: PF-06821497, Relative Bioavailability, Food Effect

What participants receive

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

PF-06821497 Treatment ADrug
A single dose of PF-06821497 administered under fasting conditions.
PF-06821497 Treatment BDrug
A single dose of PF-06821497 administered under fasting conditions.
PF-06821497 Treatment CDrug
A single dose of PF-06821497 administered under fasting conditions.
PF-06821497 Treatment DDrug
A single dose of PF-06821497 administered under fasting conditions.
PF-06821497 Treatment EDrug
A single dose of PF-06821497 administered after low fat meal
PF-06821497 Treatment FDrug
A single dose of PF-06821497 administered after high fat meal.

Study groups in NCT05767905
Study group	Role	What they receive
Part 1: PF-06821497 Sequence 1	Experimental	Participants randomized to Sequence 1 will receive Treatments A, B, and C in Periods 1 through 3, respectively in the form of tablets by mouth. Interventions: * Drug: Single dose of PF-06821497 Treatment A * Drug: Single dose of PF-06821497 Treatment B * Drug: Single dose of PF-06821497 Treatment C Receives: Drug: PF-06821497 Treatment A; Drug: PF-06821497 Treatment B; Drug: PF-06821497 Treatment C
Part 1: PF-06821497 Sequence 2	Experimental	Participants randomized to Sequence 2 will receive Treatments B, A and C in Periods 1 through 3, respectively in the form of tablets by mouth. Interventions: * Drug: Single dose of PF-06821497 Treatment A * Drug: Single dose of PF-06821497 Treatment B * Drug: Single dose of PF-06821497 Treatment C Receives: Drug: PF-06821497 Treatment A; Drug: PF-06821497 Treatment B; Drug: PF-06821497 Treatment C
Part 2: PF-06821497 Sequence 1	Experimental	Participants randomized to Sequence 1 will receive Treatments D, E and F in Periods 1 through 3, respectively in the form of tablets by mouth. Interventions: * Drug: Single dose of PF-06821497 Treatment D * Drug: Single dose of PF-06821497 Treatment E * Drug: Single dose of PF-06821497 Treatment F Receives: Drug: PF-06821497 Treatment D; Drug: PF-06821497 Treatment E; Drug: PF-06821497 Treatment F

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 0 Extrapolated to Infinite Time (AUCinf) of PF-06821497
The AUCinf was determined by AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. AUClast is the area under the concentration-time curve from 0 to time of last measurable concentration
Measured: Days 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose), 2 and 3 in Periods 1 to 3.
Maximum Plasma Concentration (Cmax) for PF-06821497.
The Cmax was observed directly from data.
Measured: Days 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose), 2 and 3 in Periods 1 to 3.

Secondary outcomes (3)

Number of Participants With Treatment Emergent Adverse Events (TEAEs).
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, was considered serious.
Measured: From screening up to Day 35
Number of Participants With Laboratory Abnormalities
Safety laboratory assessments included urinalysis, hematology, chemistry and other. All the safety laboratory samples were collected following at least a 4-hour fast.
Measured: From screening up to Day 3 of Period 3, and prior to early termination/discontinuation, up to 10 weeks.
Number of Participants With Clinically Significant ECG Findings
Single 12-lead electrocardiogram or electrocardiography (ECG) readings were taken at approximately each test. All ECG assessments were made after at least a 5-minute rest in a supine position and prior to any blood draws or vital sign measurements.
Measured: From screening up to Day 3 of Period 3, and prior to early termination/discontinuation, up to 10 weeks.

Timeline

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

17 Mar 202320 Jun 2023

First posted14 Mar 2023
Study start17 Mar 2023
Primary completion20 Jun 2023
Study completion20 Jun 2023

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: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05767905
Sponsor's protocol ID: C2321005
Other IDs: NCT05767905
Status last verified: Jun 2025
First submitted: 2 Mar 2023
Last updated: 12 Jun 2025
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 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, RANDOMIZED, OPEN-LABEL, 3-PERIOD, CROSSOVER, SINGLE-DOSE, 2-PART STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE EFFECT OF TABLET FORMULATION AND FOOD ON THE RELATIVE BIOAVAILABILITY OF PF-06821497
ClinicalTrials.gov ID: NCT05767905
Acronym / sponsor ID: C2321005
Conditions: Healthy
Keywords: PF-06821497, Relative Bioavailability, Food Effect
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 17 Mar 2023 (actual)
Primary completion: 20 Jun 2023 (actual)
Study completion: 20 Jun 2023 (actual)
First posted: 14 Mar 2023 (actual)
Results: Posted 12 Jun 2025

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 study is to understand the effect of tablet formulation and presence of food on the study medicine PF-06821497 in healthy adult participants.

The study is seeking for male and female participants who:

Are 18 years of age or more.
Are confirmed to be healthy after performing some medical and physical tests.
Weigh more than 50kgs of body weight and have a body mass index of 17 and a half kg per meter squared or more.

Each treatment consists of a single dose of PF-06821497. The treatments differ by tablet formulation and/or whether the medicine is to be given with food or without food conditions.

In each part, participants will be on the study up to 10 weeks, including the screening and follow-up periods.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Part 1: PF-06821497 Sequence 1	Experimental	Drug: PF-06821497 Treatment A, Drug: PF-06821497 Treatment B, Drug: PF-06821497 Treatment CParticipants randomized to Sequence 1 will receive Treatments A, B, and C in Periods 1 through 3, respectively in the form of tablets by mouth. Interventions: * Drug: Single dose of PF-06821497 Treatment A * Drug: Single dose of PF-06821497 Treatment B * Drug: Single dose of PF-06821497 Treatment C
Part 1: PF-06821497 Sequence 2	Experimental	Drug: PF-06821497 Treatment A, Drug: PF-06821497 Treatment B, Drug: PF-06821497 Treatment CParticipants randomized to Sequence 2 will receive Treatments B, A and C in Periods 1 through 3, respectively in the form of tablets by mouth. Interventions: * Drug: Single dose of PF-06821497 Treatment A * Drug: Single dose of PF-06821497 Treatment B * Drug: Single dose of PF-06821497 Treatment C
Part 2: PF-06821497 Sequence 1	Experimental	Drug: PF-06821497 Treatment D, Drug: PF-06821497 Treatment E, Drug: PF-06821497 Treatment FParticipants randomized to Sequence 1 will receive Treatments D, E and F in Periods 1 through 3, respectively in the form of tablets by mouth. Interventions: * Drug: Single dose of PF-06821497 Treatment D * Drug: Single dose of PF-06821497 Treatment E * Drug: Single dose of PF-06821497 Treatment F

Who may qualify

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

Key inclusion criteria (5 listed)

Participants ≥18 years of age, inclusive, at screening.
Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs.
BMI of ≥17.5 kg/m2; and a total body weight >50 kg (110 lb)
Evidence of a personally signed and dated ICD indicating that the participant has been informed of all pertinent aspects of the study.
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

Key exclusion criteria (4 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) or prior allergic reaction to any component of PF-06821497.
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 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 and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
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
PF-06821497 Treatment AA single dose of PF-06821497 administered under fasting conditions.	Drug	Part 1: PF-06821497 Sequence 1, Part 1: PF-06821497 Sequence 2
PF-06821497 Treatment BA single dose of PF-06821497 administered under fasting conditions.	Drug	Part 1: PF-06821497 Sequence 1, Part 1: PF-06821497 Sequence 2
PF-06821497 Treatment CA single dose of PF-06821497 administered under fasting conditions.	Drug	Part 1: PF-06821497 Sequence 1, Part 1: PF-06821497 Sequence 2
PF-06821497 Treatment DA single dose of PF-06821497 administered under fasting conditions.	Drug	Part 2: PF-06821497 Sequence 1
PF-06821497 Treatment EA single dose of PF-06821497 administered after low fat meal	Drug	Part 2: PF-06821497 Sequence 1
PF-06821497 Treatment FA single dose of PF-06821497 administered after high fat meal.	Drug	Part 2: PF-06821497 Sequence 1

Primary outcome

Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06821497
Time frame: Days 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose), 2 and 3 in Periods 1 to 3.
The AUCinf was determined by AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. AUClast is the area under the concentration-time curve from 0 to time of last measurable concentration
Maximum Plasma Concentration (Cmax) for PF-06821497.
Time frame: Days 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose), 2 and 3 in Periods 1 to 3.
The Cmax was observed directly from data.

3 secondary outcomes

Number of Participants With Treatment Emergent Adverse Events (TEAEs).
Time frame: From screening up to Day 35
Number of Participants With Laboratory Abnormalities
Time frame: From screening up to Day 3 of Period 3, and prior to early termination/discontinuation, up to 10 weeks.
Number of Participants With Clinically Significant ECG Findings
Time frame: From screening up to Day 3 of Period 3, and prior to early termination/discontinuation, up to 10 weeks.

Results and safety

Results posted to the registry on 12 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1: PF-06821497 Form 1 250 mg -> PF-06821497 Form 2 250 mg -> PF-06821497 Form 3 250 mg.	6	6
Part 1: PF-06821497 Form 2 250 mg -> PF-06821497 Form 1 250 mg -> PF-06821497 Form 3 250 mg	6	6
Part 2:PF-06821497 1250 mg Fasted >PF-06821497 1250 mg Fed Low-fat >PF-06821497 1250 mg Fed High-fat	6	5

Primary outcome: Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06821497

Time frame: Days 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose), 2 and 3 in Periods 1 to 3.. Geometric mean (Geometric Coefficient of Variation). Unit: ng*hr/mL

Measure	Part 1 PF-06821497 Form 1 250 mg Fasted n = 12	Part 1 PF-06821497 Form 2 250 mg Fasted n = 12	Part 1 PF-06821497 Form 3 250 mg Fasted n = 12	Part 2 PF-06821497 Form 2 1250 mg Fasted n = 6	Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat n = 6	Part 2 PF-06821497 Form 2 1250 mg Fed High-fat n = 5
Value	3302 (33)	3375 (29)	3479 (39)	11220 (48)	22810 (24)	25690 (35)

Part 1 PF-06821497 Form 1 250 mg Fasted vs Part 1 PF-06821497 Form 3 250 mg Fasted: ratio: 108.49 (90% CI 100.55 to 117.05), Mixed Models Analysis
Part 1 PF-06821497 Form 2 250 mg Fasted vs Part 1 PF-06821497 Form 3 250 mg Fasted: ratio: 106.16 (90% CI 98.39 to 114.54), Mixed Models Analysis
Part 2 PF-06821497 Form 2 1250 mg Fasted vs Part 2 PF-06821497 Form 2 1250 mg Fed High-fat: ratio: 228.99 (90% CI 178.67 to 293.48), Mixed Models Analysis

Population analysed: The pharmacokinetic (PK) parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PF-06821497 PK parameters of primary interest in at least 1 treatment period.

Primary outcome: Maximum Plasma Concentration (Cmax) for PF-06821497.

Time frame: Days 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose), 2 and 3 in Periods 1 to 3.. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	Part 1 PF-06821497 Form 1 250 mg Fasted n = 12	Part 1 PF-06821497 Form 2 250 mg Fasted n = 12	Part 1 PF-06821497 Form 3 250 mg Fasted n = 12	Part 2 PF-06821497 Form 2 1250 mg Fasted n = 6	Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat n = 6	Part 2 PF-06821497 Form 2 1250 mg Fed High-fat n = 5
Value	862.6 (50)	1023 (35)	1255 (37)	2699 (31)	7685 (28)	8905 (7)

Part 1 PF-06821497 Form 1 250 mg Fasted vs Part 1 PF-06821497 Form 3 250 mg Fasted: ratio: 145.49 (90% CI 121.29 to 174.53), Mixed Models Analysis
Part 1 PF-06821497 Form 2 250 mg Fasted vs Part 1 PF-06821497 Form 3 250 mg Fasted: ratio: 122.64 (90% CI 102.24 to 147.12), Mixed Models Analysis
Part 2 PF-06821497 Form 2 1250 mg Fasted vs Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat: ratio: 284.72 (90% CI 226.39 to 358.06), Mixed Models Analysis

Population analysed: The PK concentration population was defined as all participants randomized and treated who had at least 1 PF-06821497 concentration in at least 1 treatment period.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From screening up to Day 35.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1 PF-06821497 Form 1 250 mg Fasted	0 of 12 (0%)	5 of 12 (41.7%)	0 of 12
Part 1 PF-06821497 Form 2 250 mg Fasted	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12
Part 1 PF-06821497 Form 3 250 mg Fasted	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12
Part 2 PF-06821497 Form 2 1250 mg Fasted	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Part 2 PF-06821497 Form 2 1250 mg Fed High-fat	1 of 5 (20%)	2 of 5 (40%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
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 PF-06821497 Treatment A, PF-06821497 Treatment B and PF-06821497 Treatment C in people with Healthy, run by Pfizer at 1 site in United States.

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 5 inclusion and 4 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 12 Jun 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 United States. 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 12 Jun 2025). 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 0 Extrapolated to Infinite Time (AUCinf) of PF-06821497 (time frame: Days 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose), 2 and 3 in Periods 1 to 3.). 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 NCT05767905.

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 12 Jun 2025.