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| ID | Type | Description | Link |
|---|---|---|---|
| NCT05767905 | Registry Identifier | ClinicalTrials.gov |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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| 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:
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| 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06821497 Treatment A | Drug | A single dose of PF-06821497 administered under fasting conditions. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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A total of 18 participants (12 participants in Part 1 and 6 participants in Part 2) were randomized and assigned to study treatments.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: PF-06821497 Form 1 250 mg -> PF-06821497 Form 2 250 mg -> PF-06821497 Form 3 250 mg. | Participants received PF-06821497 (formulation 1) 250 mg material sparing tablet (MST) on Day 1 of period 1 under fasted condition, and after a minimum of 5-day washout period, participants received PF-06821497 (formulation 2) 250 mg wet granulation (WG) tablet on Day 1 of period 2 under fasted condition. Then after a minimum of 5-day washout period, participants received PF-06821497 (formulation 3) 250 mg WG tablet (larger API particle size) on Day 1 of period 3 under fasted condition. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 2, 2023 | Apr 12, 2024 |
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Open-label Study
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| PF-06821497 Treatment B | Drug | A single dose of PF-06821497 administered under fasting conditions. |
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| PF-06821497 Treatment C | Drug | A single dose of PF-06821497 administered under fasting conditions. |
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| PF-06821497 Treatment D | Drug | A single dose of PF-06821497 administered under fasting conditions. |
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| PF-06821497 Treatment E | Drug | A single dose of PF-06821497 administered after low fat meal |
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| PF-06821497 Treatment F | Drug | A single dose of PF-06821497 administered after high fat meal. |
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| 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. | 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. | From screening up to Day 3 of Period 3, and prior to early termination/discontinuation, up to 10 weeks. |
| FG001 | Part 1: PF-06821497 Form 2 250 mg -> PF-06821497 Form 1 250 mg -> PF-06821497 Form 3 250 mg | Participants received PF-06821497 (formulation 2) 250 mg WG tablet on Day 1 of period 1 under fasted condition, and after a minimum of 5-day washout period, participants received PF-06821497 (formulation 1) 250 mg MST tablet on Day 1 of period 2 under fasted condition. Then after a minimum of 5-day washout period, participants received PF-06821497 (formulation 3) 250 mg WG tablet (larger API particle size) on Day 1 of period 3 under fasted condition. |
| FG002 | Part 2:PF-06821497 1250 mg Fasted >PF-06821497 1250 mg Fed Low-fat >PF-06821497 1250 mg Fed High-fat | Participants received PF-06821497 (formulation 2) 1250 mg WG tablet on Day 1 of period 1 under fasted condition, and after a minimum of 5-day washout period, participants received a received a low-fat, low-calorie breakfast 30 minutes prior to dosing of PF-06821497 (formulation 2) 1250 mg WG tablet on Day 1 of period 2. Then after a minimum of 5-day washout period, participants received a a high-fat, high-calorie breakfast 30 minutes prior to dosing of PF-06821497 (formulation 2) 1250mg WG tablet. |
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The baseline analysis population included all participants enrolled in the study, and the results were presented by part.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1 | In Part 1, each enrolled participant participated in 3 study periods to receive 3 different treatments(Treatment A: Single 250 mg dose (1 × 250 mg) of MST tablet formulation (Formulation 1), fasted; Treatment B: Single 250 mg dose (1 × 250 mg) of WG tablet formulation (Formulation 2), fasted; Treatment C: Single 250 mg dose (1 × 250 mg) of WG tablet formulation (larger API particle size) (Formulation 3), fasted.) according to the sequence determined by randomization with 5-day washouts between PF-06821497 administration. |
| BG001 | Part 2 | In Part 2, each enrolled participant participated in 3 study periods to receive 3 different treatments (Treatment D: Single 1250 mg dose (5 × 250 mg) of WG tablet formulation (Formulation 2), fasted; Treatment E: Single 1250 mg dose (5 × 250 mg) of WG tablet formulation (Formulation 2), fed, low-fat; Treatment F: Single 1250 mg dose (5 × 250 mg) of WG tablet formulation (Formulation 2), fed, high-fat.) according to the sequence determined by randomization with 5-day washouts between PF-06821497 administration. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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 | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | 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. |
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| Primary | Maximum Plasma Concentration (Cmax) for PF-06821497. | The Cmax was observed directly from data. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 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. |
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| Secondary | 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. | The safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants was analyzed according to the product they actually received. | Posted | Count of Participants | Participants | From screening up to Day 35 |
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| Secondary | 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. | The analysis population included all participants randomly assigned to study intervention and who took at least one dose of study intervention. | Posted | Count of Participants | Participants | From screening up to Day 3 of Period 3, and prior to early termination/discontinuation, up to 10 weeks. |
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| Secondary | 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. | The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | Count of Participants | Participants | From screening up to Day 3 of Period 3, and prior to early termination/discontinuation, up to 10 weeks. |
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From screening up to Day 35.
Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1 PF-06821497 Form 1 250 mg Fasted | Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 material sparing tablet (MST). | 0 | 12 | 0 | 12 | 5 | 12 |
| EG001 | Part 1 PF-06821497 Form 2 250 mg Fasted | Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 wet granulation (WG) tablet. | 0 | 12 | 0 | 12 | 4 | 12 |
| EG002 | Part 1 PF-06821497 Form 3 250 mg Fasted | Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 WG tablet (larger API particle size). | 0 | 12 | 0 | 12 | 2 | 12 |
| EG003 | Part 2 PF-06821497 Form 2 1250 mg Fasted | Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1, participants received a 1250 mg dose of PF-06821497 WG tablet | 0 | 6 | 0 | 6 | 3 | 6 |
| EG004 | Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat | Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a low-fat, low-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet | 0 | 6 | 0 | 6 | 3 | 6 |
| EG005 | Part 2 PF-06821497 Form 2 1250 mg Fed High-fat | Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a high-fat, high-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet | 0 | 5 | 1 | 5 | 2 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Wrist fracture | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Eyelid pain | Eye disorders | MedDRA v26.0 | Non-systematic Assessment |
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| abdominal discomfort | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Vessel puncture site bruise | General disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Vessel puncture site pain | General disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
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| Nail avulsion | Injury, poisoning and procedural complications | MedDRA v26.0 | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA v26.0 | Non-systematic Assessment |
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| Coagulation time prolonged | Investigations | MedDRA v26.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Disturbance in attention | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Urine odour abnormal | Renal and urinary disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Rash macular | Skin and subcutaneous tissue disorders | MedDRA v26.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 30, 2023 | Apr 12, 2024 | SAP_001.pdf |
| Title | Measurements |
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| >= 65 years |
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| Male |
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| Black or African American |
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| Black or African American, White |
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| Black or African American, White, American Indian or Alaska Native |
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| American Indian or Alaska Native |
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Part 1 PF-06821497 Form 3 250 mg Fasted was the Test treatment and Part 1 PF-06821497 Form 2 250 mg Fasted was the Reference treatment. |
| Mixed Models Analysis |
Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means |
| ratio |
| 106.16 |
| 2-Sided |
| 90 |
| 98.39 |
| 114.54 |
| Other |
| Part 2 PF-06821497 Form 2 1250 mg Fed High-fat was the Test treatment and Part 2 PF-06821497 Form 2 1250 mg Fasted was the Reference treatment. | Mixed Models Analysis | Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means | ratio | 228.99 | 2-Sided | 90 | 178.67 | 293.48 | Other |
| Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat was the Test treatment and Part 2 PF-06821497 Form 2 1250 mg Fasted was the Reference treatment. | ratio | 207.19 | 2-Sided | 90 | 164.41 | 261.09 | Other |
| Part 1 PF-06821497 Form 1 250 mg Fasted was the Reference treatment, and Part 1 PF-06821497 Form 2 250 mg Fasted was the Test treatment | Mixed Models Analysis | Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means | ratio | 102.19 | 2-Sided | 90 | 95.55 | 109.30 | Other |
| OG003 | Part 2 PF-06821497 Form 2 1250 mg Fasted | Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1, participants received a 1250 mg dose of PF-06821497 WG tablet. |
| OG004 | Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat | Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a low-fat, low-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet |
| OG005 | Part 2 PF-06821497 Form 2 1250 mg Fed High-fat | Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a high-fat, high-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet |
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| OG002 | Part 1 PF-06821497 Form 3 250 mg Fasted | Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 WG tablet (larger API particle size). |
| OG003 | Part 2 PF-06821497 Form 2 1250 mg Fasted | Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1, participants received a 1250 mg dose of PF-06821497 WG tablet. |
| OG004 | Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat | Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a low-fat, low-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet |
| OG005 | Part 2 PF-06821497 Form 2 1250 mg Fed High-fat | Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a high-fat, high-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet |
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| OG003 | Part 2 PF-06821497 Form 2 1250 mg Fasted | Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 WG tablet (larger API particle size). |
| OG004 | Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat | Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a low-fat, low-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet |
| OG005 | Part 2 PF-06821497 Form 2 1250 mg Fed High-fat | Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a high-fat, high-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet |
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Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 WG tablet (larger API particle size).
| OG003 | Part 2 PF-06821497 Form 2 1250 mg Fasted | Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1, participants received a 1250 mg dose of PF-06821497 WG tablet. |
| OG004 | Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat | Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a low-fat, low-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet |
| OG005 | Part 2 PF-06821497 Form 2 1250 mg Fed High-fat | Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a high-fat, high-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet |
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