A Phase 1 interventional study of PF-06821497 Treatment A and PF-06821497 Treatment B in Healthy, sponsored by Pfizer. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-12.
Sponsored by Pfizer · Phase 1, Interventional, and Basic science
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:
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.
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: PF-06821497 Treatment A · Drug: PF-06821497 Treatment B · Drug: PF-06821497 Treatment C
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
Drug: PF-06821497 Treatment A · Drug: PF-06821497 Treatment B · Drug: PF-06821497 Treatment C
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
Drug: PF-06821497 Treatment D · Drug: PF-06821497 Treatment E · Drug: PF-06821497 Treatment F
A single dose of PF-06821497 administered under fasting conditions.
A single dose of PF-06821497 administered under fasting conditions.
A single dose of PF-06821497 administered under fasting conditions.
A single dose of PF-06821497 administered under fasting conditions.
A single dose of PF-06821497 administered after low fat meal
A single dose of PF-06821497 administered after high fat meal.
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
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.
Maximum Plasma Concentration (Cmax) for PF-06821497.
The Cmax was observed directly from data.
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.
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.
Time frame: 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.
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
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.
Time frame: From screening up to Day 3 of Period 3, and prior to early termination/discontinuation, up to 10 weeks.
| Milestone | Part 1: PF-06821497 Form 1 250 mg -> PF-06821497 Form 2 250 mg -> PF-06821497 Form 3 250 mg. | Part 1: PF-06821497 Form 2 250 mg -> PF-06821497 Form 1 250 mg -> PF-06821497 Form 3 250 mg | Part 2:PF-06821497 1250 mg Fasted >PF-06821497 1250 mg Fed Low-fat >PF-06821497 1250 mg Fed High-fat |
|---|---|---|---|
| Started | 6 | 6 | 6 |
| Completed | 6 | 6 | 5 |
| Not completed | 0 | 0 | 1 |
| Withdrew: Adverse event | 0 | 0 | 1 |
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
| ng*hr/mL | Part 1 PF-06821497 Form 1 250 mg Fasted | Part 1 PF-06821497 Form 2 250 mg Fasted | Part 1 PF-06821497 Form 3 250 mg Fasted | Part 2 PF-06821497 Form 2 1250 mg Fasted | Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat | Part 2 PF-06821497 Form 2 1250 mg Fed High-fat |
|---|---|---|---|---|---|---|
| Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06821497 | 3302 ± 33 | 3375 ± 29 | 3479 ± 39 | 11220 ± 48 | 22810 ± 24 | 25690 ± 35 |
The Cmax was observed directly from data.
| ng/mL | Part 1 PF-06821497 Form 1 250 mg Fasted | Part 1 PF-06821497 Form 2 250 mg Fasted | Part 1 PF-06821497 Form 3 250 mg Fasted | Part 2 PF-06821497 Form 2 1250 mg Fasted | Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat | Part 2 PF-06821497 Form 2 1250 mg Fed High-fat |
|---|---|---|---|---|---|---|
| Maximum Plasma Concentration (Cmax) for PF-06821497. | 862.6 ± 50 | 1023 ± 35 | 1255 ± 37 | 2699 ± 31 | 7685 ± 28 | 8905 ± 7 |
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.
| Participants | Part 1 PF-06821497 Form 1 250 mg Fasted | Part 1 PF-06821497 Form 2 250 mg Fasted | Part 1 PF-06821497 Form 3 250 mg Fasted | Part 2 PF-06821497 Form 2 1250 mg Fasted | Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat | Part 2 PF-06821497 Form 2 1250 mg Fed High-fat |
|---|---|---|---|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs). | 5 | 4 | 2 | 3 | 3 | 2 |
Safety laboratory assessments included urinalysis, hematology, chemistry and other. All the safety laboratory samples were collected following at least a 4-hour fast.
| Participants | Part 1 PF-06821497 Form 1 250 mg Fasted | Part 1 PF-06821497 Form 2 250 mg Fasted | Part 1 PF-06821497 Form 3 250 mg Fasted | Part 2 PF-06821497 Form 2 1250 mg Fasted | Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat | Part 2 PF-06821497 Form 2 1250 mg Fed High-fat |
|---|---|---|---|---|---|---|
| Number of Participants With Laboratory Abnormalities | 0 | 0 | 0 | 0 | 1 | 1 |
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.
| Participants | Part 1 PF-06821497 Form 1 250 mg Fasted | Part 1 PF-06821497 Form 2 250 mg Fasted | Part 1 PF-06821497 Form 3 250 mg Fasted | Part 2 PF-06821497 Form 2 1250 mg Fasted | Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat | Part 2 PF-06821497 Form 2 1250 mg Fed High-fat |
|---|---|---|---|---|---|---|
| PR Interval, aggregate (msec), value > = 300 | 0 | 0 | 0 | 0 | 0 | 0 |
| PR Interval, aggregate (msec), %Change >= 25/50% | 0 | 0 | 0 | 0 | 0 | 0 |
| QRS Duration, aggregate (msec), value >= 140 | 0 | 0 | 0 | 0 | 0 | 0 |
| QRS Duration, aggregate (msec), %Change >= 50% | 0 | 0 | 0 | 0 | 0 | 0 |
| QT Interval, aggregate (msec), value >= 500 | 0 | 0 | 0 | 0 | 0 | 0 |
| QTcB Interval, aggregate (msec), 450 <= value < 480 | 0 | 1 | 0 | 0 | 0 | 0 |
| QTcB Interval, aggregate (msec), 480 <= value < 500 | 0 | 0 | 0 | 0 | 0 | 0 |
| QTcB Interval, aggregate (msec), value >= 500 | 0 | 0 | 0 | 0 | 0 | 0 |
| QTcB Interval, aggregate (msec), 30 <= change < 60 | 0 | 0 | 1 | 0 | 0 | 0 |
| QTcB Interval, aggregate (msec), change >= 60 | 0 | 0 | 0 | 0 | 0 | 0 |
| QTcF Interval, aggregate (msec), 450 <= value < 480 | 0 | 0 | 0 | 0 | 0 | 0 |
| QTcF Interval, aggregate (msec), 480 <= value < 500 | 0 | 0 | 0 | 0 | 0 | 0 |
| QTcF Interval, aggregate (msec), value >= 500 | 0 | 0 | 0 | 0 | 0 | 0 |
| QTcF Interval, aggregate (msec), 30 <= change < 60 | 0 | 0 | 0 | 0 | 0 | 0 |
| QTcF Interval, aggregate (msec), change >= 60 | 0 | 0 | 0 | 0 | 0 | 0 |
Collected over From screening up to Day 35.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part 1 PF-06821497 Form 1 250 mg Fasted | 0/12 (0%) | 0/12 (0%) | 5/12 (41.7%) |
| Part 1 PF-06821497 Form 2 250 mg Fasted | 0/12 (0%) | 0/12 (0%) | 4/12 (33.3%) |
| Part 1 PF-06821497 Form 3 250 mg Fasted | 0/12 (0%) | 0/12 (0%) | 2/12 (16.7%) |
| Part 2 PF-06821497 Form 2 1250 mg Fasted | 0/6 (0%) | 0/6 (0%) | 3/6 (50%) |
| Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat | 0/6 (0%) | 0/6 (0%) | 3/6 (50%) |
| Part 2 PF-06821497 Form 2 1250 mg Fed High-fat | 0/5 (0%) | 1/5 (20%) | 2/5 (40%) |
| Event | Part 1 PF-06821497 Form 1 250 mg Fasted | Part 1 PF-06821497 Form 2 250 mg Fasted | Part 1 PF-06821497 Form 3 250 mg Fasted | Part 2 PF-06821497 Form 2 1250 mg Fasted | Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat | Part 2 PF-06821497 Form 2 1250 mg Fed High-fat |
|---|---|---|---|---|---|---|
| Wrist fractureInjury, poisoning and procedural complications | 0/12 | 0/12 | 0/12 | 0/6 | 0/6 | 1/5 |
| Event | Part 1 PF-06821497 Form 1 250 mg Fasted | Part 1 PF-06821497 Form 2 250 mg Fasted | Part 1 PF-06821497 Form 3 250 mg Fasted | Part 2 PF-06821497 Form 2 1250 mg Fasted | Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat | Part 2 PF-06821497 Form 2 1250 mg Fed High-fat |
|---|---|---|---|---|---|---|
| FallInjury, poisoning and procedural complications | 0/12 | 0/12 | 0/12 | 0/6 | 0/6 | 1/5 |
| HeadacheNervous system disorders | 2/12 | 1/12 | 0/12 | 0/6 | 0/6 | 1/5 |
| Eyelid painEye disorders | 0/12 | 0/12 | 0/12 | 0/6 | 1/6 | 0/5 |
| abdominal discomfortGastrointestinal disorders | 0/12 | 0/12 | 0/12 | 0/6 | 1/6 | 0/5 |
| Vessel puncture site painGeneral disorders | 0/12 | 1/12 | 1/12 | 0/6 | 1/6 | 0/5 |
| Alanine aminotransferase increasedInvestigations | 0/12 | 0/12 | 0/12 | 1/6 | 0/6 | 0/5 |
| Coagulation time prolongedInvestigations | 0/12 | 0/12 | 0/12 | 1/6 | 0/6 | 0/5 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 0/12 | 0/12 | 0/12 | 0/6 | 1/6 | 0/5 |
| MyalgiaMusculoskeletal and connective tissue disorders | 0/12 | 0/12 | 0/12 | 0/6 | 1/6 | 0/5 |
| Rash macularSkin and subcutaneous tissue disorders | 0/12 | 0/12 | 0/12 | 1/6 | 0/6 | 0/5 |
The baseline analysis population included all participants enrolled in the study, and the results were presented by part.
| Age, Customized(Participants) | Part 1 | Part 2 | Total |
|---|---|---|---|
| 18 -44 years | 7 | 2 | 9 |
| 45 - 64 years | 4 | 3 | 7 |
| >= 65 years | 1 | 1 | 2 |
| Sex: Female, Male(Participants) | Part 1 | Part 2 | Total |
|---|---|---|---|
| Female | 6 | 5 | 11 |
| Male | 6 | 1 | 7 |
| Race/Ethnicity, Customized(Participants) | Part 1 | Part 2 | Total |
|---|---|---|---|
| White | 7 | 4 | 11 |
| Black or African American | 3 | 1 | 4 |
| Black or African American, White | 1 | 0 | 1 |
| Black or African American, White, American Indian or Alaska Native | 1 | 0 | 1 |
| American Indian or Alaska Native | 0 | 1 | 1 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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