A First in Human Study to Evaluate Safety, Tolerability,... | NCT03210961 | Trialant
NCT03210961
Sponsor
Pfizer
Status
Completed
Last Update Posted
Mar 31, 2020Actual
Enrollment
109Actual
Phase
Phase 1
Conditions
Plaque Psoriasis
Interventions
PF-06826647 tablet
PF-06826647 oral suspension
Placebo oral solution/suspension
Placebo tablet
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03210961
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
C2501001
Secondary IDs
Not provided
Brief Title
A First in Human Study to Evaluate Safety, Tolerability, and Pharmacology of PF-06826647 in Healthy Subjects and Subjects With Plaque Psoriasis
Official Title
A PHASE 1, WITHIN COHORT, RANDOMIZED, DOUBLE BLIND, THIRD-PARTY OPEN, PLACEBO-CONTROLLED, SINGLE- AND MULTIPLE DOSE ESCALATION, PARALLEL GROUP STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-06826647 IN HEALTHY SUBJECTS AND SUBJECTS WITH PLAQUE PSORIASIS
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Mar 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 14, 2017Actual
Primary Completion Date
Jan 25, 2019Actual
Completion Date
Jan 25, 2019Actual
First Submitted Date
Jul 3, 2017
First Submission Date that Met QC Criteria
Jul 5, 2017
First Posted Date
Jul 7, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Jan 13, 2020
Results First Submitted that Met QC Criteria
Mar 28, 2020
Results First Posted Date
Mar 31, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Mar 28, 2020
Last Update Posted Date
Mar 31, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This first in human study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-06826647 in healthy subjects and subjects with plaque psoriasis.
Detailed Description
Not provided
Conditions Module
Conditions
Plaque Psoriasis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
109Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
PF-06826647 tablet
Experimental
Drug: PF-06826647 tablet
Placebo tablet
Placebo Comparator
Other: Placebo tablet
PF-06826647 oral suspension
Experimental
Drug: PF-06826647 oral suspension
Placebo oral solution/suspension
Placebo Comparator
Other: Placebo oral solution/suspension
Interventions
Name
Type
Description
Arm Group Labels
Other Names
PF-06826647 tablet
Drug
PF-06826647 tablet for oral administration
PF-06826647 tablet
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period)
Maximum absolute values and changes from baseline for vital signs (for supine systolic/diastolic blood pressure [BP] and supine pulse rate [PR]) were summarized descriptively by treatment. Numbers of participants meeting the categorical criteria were provided.
Number of participants in PBO SAD cohorts = number of participants in [PBO SAD (3mg, 10mg)] cohorts + number of participants in [PBO SAD -> PBO QD MAD] cohorts.
Baseline up to Day 8
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period)
Maximum absolute values and changes from baseline for vital signs (for supine systolic/diastolic blood pressure and supine pulse rate) were summarized descriptively by treatment. Numbers of participants meeting the categorical criteria were provided.
Baseline up to Day 28
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
Maximum absolute values and changes from baseline for vital signs (for supine systolic/diastolic blood pressure and supine pulse rate) were summarized descriptively by treatment. Numbers of participants meeting the categorical criteria were provided.
Baseline up to Day 56
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period)
Physical examinations were conducted by a physician, trained physician assistant, or nurse practitioner as acceptable according to local regulation. A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The examination assessed the participants for any potential changes in general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. Findings were considered to be clinically significant based on investigator's decision.
Number of participants in PBO SAD cohorts = number of participants in [PBO SAD (3mg, 10mg)] cohorts + number of participants in [PBO SAD -> PBO QD MAD] cohorts.
Secondary Outcomes
Measure
Description
Time Frame
Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) (SAD Period)
AUCinf = Area under the plasma concentration versus time curve (AUC) from time 0 (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Healthy Participants:
Inclusion Criteria:
Healthy male subjects between ages of 18-55 years
Healthy female subjects of non-childbearing potential between the ages of 18-55 years
Body Mass Index (BMI) of 17.5 to 30.5kg/m2; and a total body weight >50kg (110lbs).
No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
(Optional) Japanese subjects who have four Japanese biologic grandparents born in Japan
Exclusion Criteria:
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product
Have a clinically significant infection currently or within 6 months of first dose of study drug
Psoriasis Participants:
Inclusion Criteria:
Healthy male subjects between ages of 18-65 years
Healthy female subjects of non-childbearing potential between the ages of 18-65 years
Have a diagnosis of plaque psoriasis for at least 6 months prior to first study dose
Have plaque-type psoriasis covering at least 15% of total body surface area (BSA) at Day-1(prior to randomization in the study
No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
Exclusion Criteria:
Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis
Have a clinically significant infection currently or within 6 months of first dose of study drug, or a history of chronic or recurrent infectious disease
Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product
Tehlirian C, Peeva E, Kieras E, Scaramozza M, Roberts ES, Singh RSP, Pradhan V, Banerjee A, Garcet S, Xi L, Gale JD, Vincent MS, Krueger J. Safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of the oral TYK2 inhibitor PF-06826647 in participants with plaque psoriasis: a phase 1, randomised, double-blind, placebo-controlled, parallel-group study. Lancet Rheumatol. 2021 Mar;3(3):e204-e213. doi: 10.1016/S2665-9913(20)30397-0. Epub 2020 Dec 24.
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
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.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
A total of 208 potential participants were screened after signing an informed consent form, of whom 109 participants were randomized to receive study treatment.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo (PBO) SAD (3 Milligrams [mg], 10 mg)
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, or 10 mg single dose (SD) cohort in fasted state.
FG001
PBO SAD Followed by (->) PBO QD MAD
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Apr 5, 2018
Jan 13, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Combination single and multiple ascending dose design. Cohorts of participants are assigned to receive interventions based on acceptable safety, tolerability, and pharmacokinetics of previous dose cohort
PF-06826647 suspension for oral administration (oral suspension to be administered to the 3mg starting dose cohort only)
PF-06826647 oral suspension
Placebo oral solution/suspension
Other
placebo oral solution for the single ascending dose, first cohort only
Placebo oral solution/suspension
Placebo tablet
Other
Matching placebo tablet
Placebo tablet
Baseline up to Day 8
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period)
Physical examinations were conducted by a physician, trained physician assistant, or nurse practitioner as acceptable according to local regulation. A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The examination assessed the participants for any potential changes in general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. Findings were considered to be clinically significant based on investigator's decision.
Baseline up to Day 28
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
Physical examinations were conducted by a physician, trained physician assistant, or nurse practitioner as acceptable according to local regulation. A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The examination assessed the participants for any potential changes in general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. Findings were considered to be clinically significant based on investigator's decision.
Baseline up to Day 56
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period)
ECG endpoints and changes from baseline (QTcF, PR and QRS) were summarized descriptively by cohort and treatment using pre-defined categories. Numbers of participants meeting the categorical criteria were provided. All planned and unplanned post-dose time points were counted in these categorical summaries. Categorical summarization criteria for ECG were as follows: 1) QTcF maximum absolute value ≥450 and <480 millisecond (msec), ≥480 and <500 msec. ≥500 msec; 2) QTcF maximum increase ≥30 and <60 msec, ≥60 msec; 3) PR maximum absolute value ≥300 msec; 4) PR maximum increases from baseline ≥25% if baseline >200 msec, ≥50% if baseline ≤200 msec; 5) QRS maximum absolute value ≥140 msec; 6) QRS maximum increase from baseline ≥50%.
Number of participants in PBO SAD cohorts = number of participants in [PBO SAD (3mg, 10mg)] cohorts + number of participants in [PBO SAD -> PBO QD MAD] cohorts.
Baseline up to Day 8
Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period)
ECG endpoints and changes from baseline (QTcF, PR and QRS) were summarized descriptively by cohort and treatment using pre-defined categories. Numbers of participants meeting the categorical criteria were provided. All planned and unplanned post-dose time points were counted in these categorical summaries. Categorical summarization criteria for ECG were as follows: 1) QTcF maximum absolute value ≥450 and <480 millisecond (msec), ≥480 and <500 msec. ≥500 msec; 2) QTcF maximum increase ≥30 and <60 msec, ≥60 msec; 3) PR maximum absolute value ≥300 msec; 4) PR maximum increases from baseline ≥25% if baseline >200 msec, ≥50% if baseline ≤200 msec; 5) QRS maximum absolute value ≥140 msec; 6) QRS maximum increase from baseline ≥50%.
Baseline up to Day 28
Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
ECG endpoints and changes from baseline (QTcF, PR and QRS) were summarized descriptively by cohort and treatment using pre-defined categories. Numbers of participants meeting the categorical criteria were provided. All planned and unplanned post-dose time points were counted in these categorical summaries. Categorical summarization criteria for ECG were as follows: 1) QTcF maximum absolute value ≥450 and <480 millisecond (msec), ≥480 and <500 msec. ≥500 msec; 2) QTcF maximum increase ≥30 and <60 msec, ≥60 msec; 3) PR maximum absolute value ≥300 msec; 4) PR maximum increases from baseline ≥25% if baseline >200 msec, ≥50% if baseline ≤200 msec; 5) QRS maximum absolute value ≥140 msec; 6) QRS maximum increase from baseline ≥50%.
Baseline up to Day 56
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period)
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. All events occurring following start of the treatment or increasing in severity were counted as treatment emergent. Events that occurred in a non-treatment period (eg, washout or follow-up) were counted as treatment emergent and attributed to the previous treatment taken. For each event, the investigator pursued and obtained adequate information both to determine the outcome and to assess whether it meets the criteria for classification as an SAE.
PBO SAD cohorts = [PBO SAD (3mg, 10mg)] cohorts + [PBO SAD -> PBO QD MAD] cohorts.
Baseline up to Day 8
Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period)
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. All events occurring following start of the treatment or increasing in severity were counted as treatment emergent. Events that occurred in a non-treatment period (eg, washout or follow-up) were counted as treatment emergent and attributed to the previous treatment taken. For each event, the investigator pursued and obtained adequate information both to determine the outcome and to assess whether it meets the criteria for classification as an SAE.
Baseline up to Day 28
Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts)
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. All events occurring following start of the treatment or increasing in severity were counted as treatment emergent. Events that occurred in a non-treatment period (eg, washout or follow-up) were counted as treatment emergent and attributed to the previous treatment taken. For each event, the investigator pursued and obtained adequate information both to determine the outcome and to assess whether it meets the criteria for classification as an SAE.
Baseline up to Day 84
Number of Participants With Laboratory Abnormalities (SAD Period)
Laboratory data were listed and summarized by treatment in accordance with the sponsor reporting standards. Parameters for laboratory abnormalities evaluation included: erythrocyte mean corpuscular volume (Ery. MCV), erythrocyte mean corpuscular hemoglobin (Ery. MCH), reticulocytes/erythrocytes (%), limphocytes, eosinophils, bilirubin, aspartate aminotransferase (AST), urate, high-density lipoproteins (HDL) cholesterol, low-density lipoproteins (LDL) cholesterol, triglycerides, cholesterol, ketones, nitrite, leukocyte esterase, epithelial cells, urinalysis-bacteria.
Number of participants in PBO SAD cohorts = number of participants in [PBO SAD (3mg, 10mg)] cohorts + number of participants in [PBO SAD -> PBO QD MAD] cohorts.
Baseline up to Day 8
Number of Participants With Laboratory Abnormalities (MAD Period)
Laboratory data were listed and summarized by treatment in accordance with the sponsor reporting standards. Parameters and corresponding primary criteria for laboratory abnormalities evaluation included: Ery. MCV <0.9 × LLN, Ery. Mean corpuscular hemoglobin (Ery. MCH) <0.9 × LLN or >1.1 ULN, reticulocytes/erythrocytes (%) >1.5 × ULN, lymphocytes <0.8 × LLN or >1.2 × ULN, neutrophils <0.8 × LLN, eosinophils >1.2 × ULN, bilirubin >1.5 × ULN, urate >1.2 × ULN, HDL cholesterol <0.8 × LLN, LDL cholesterol >1.2 × ULN, triglycerides >1.3 × ULN, bicarbonate >1.1 × ULN, cholesterol >1.3 × ULN, urine glucose ≥1, urine hemoglobin ≥1, nitrite ≥1, leukocyte esterase ≥1, epithelial cells ≥6/LPF, urinalysis-casts >1/LPF, urinalysis-bacteria >20/HPF, urine 24 hours creatinine >1.1 × ULN.
Baseline up to Day 28
Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)
AUCinf = Area under the plasma concentration versus time curve (AUC) from time 0 (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf). AUCinf(dn) = AUCinf / dose. Dose normalized AUC values of PF-06826647 was plotted against dose and included individual participant values and the geometric means for each dose. These plots were used to help understand the relationship between the plasma PK parameters and dose.
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Area Under the Concentration-Time Profile From Time 0 to 24 Hours (AUC24) (SAD Period)
AUC24 was summarized by dosing regimen and period. It was determined by linear/log trapezoidal method.
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) (SAD Period)
AUClast was summarized by dosing regimen and period. It was determined by linear/log trapezoidal method.
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
AUClast(dn) = AUClast / dose. Dose normalized AUC values of PF-06826647 were plotted against dose and included individual participant values and the geometric means for each dose. These plots was used to help understand the relationship between the plasma PK parameters and dose.
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Maximum Plasma Concentration (Cmax) (SAD Period)
Cmax was summarized by dosing regimen and period. It was observed directly from data.
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Dose Normalized Cmax (Cmax[dn]) (SAD Period)
Cmax(dn) = Cmax / dose. To assess the relationship between Cmax and dose, dose normalized Cmax was plotted against dose, and included individual participant values and the geometric means for each dose.
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Time for Cmax (Tmax) (SAD Period)
Tmax was summarized by dosing regimen and period. It was observed directly from data as time of first occurrence.
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
t1/2 was summarized by dosing regimen and period. It was determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Mean Residence Time (MRT) (SAD Period)
MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from time 0 to infinity.
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Apparent Volume of Distribution (Vz/F) (SAD Period)
Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Apparent Clearance (CL/F) (SAD Period)
CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Area Under the Plasma Concentration-Time Profile Over the Dosing Interval Ï„ (AUCÏ„) (MAD Period Day 1)
AUCÏ„ was summarized by dosing regimen and period. Dosing interval was the interval Ï„ between administration of doses of drug. In this study, the dosing interval was 24 hours for QD dosing and 12 hours for BID dosing. It was determined by linear/log trapezoidal method.
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Dose Normalized AUCÏ„ (AUCÏ„[dn]) (MAD Period Day 1)
Area Under the Plasma Concentration-Time Profile over the Dosing interval Ï„ (AUCÏ„). Dosing interval was the interval Ï„ between administration of doses of drug. In this study, the dosing interval Ï„ was 24 hours for QD dosing and 12 hours for BID dosing.
AUCÏ„(dn) = AUCÏ„ / Dose. To assess the relationship between the PK parameters and the dose, dose normalized AUCÏ„ was plotted against dose, and included individual participant values and the geometric means for each dose.
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Cmax (MAD Period Day 1)
Cmax was summarized by dosing regimen and period. It was observed directly from data.
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Cmax(dn) (MAD Period Day 1)
Cmax(dn) = Cmax / dose. To assess the relationship between Cmax and dose, dose normalized Cmax was plotted against dose, and included individual participant values and the geometric means for each dose.
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Tmax (MAD Period Day 1)
Tmax was summarized by dosing regimen and period. It was observed directly from data as time of first occurrence.
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
AUCÏ„ (MAD Period Day 10)
AUCÏ„ was summarized by dosing regimen and period. Dosing interval was the interval Ï„ between administration of doses of drug. In this study, the dosing interval was 24 hours for QD dosing and 12 hours for BID dosing. It was determined by linear/log trapezoidal method.
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
AUCÏ„(dn) (MAD Period Day 10)
Area Under the Plasma Concentration-Time Profile over the Dosing interval Ï„ (AUCÏ„). Dosing interval was the interval Ï„ between administration of doses of drug. In this study, the dosing interval Ï„ was 24 hours for QD dosing and 12 hours for BID dosing.
AUCÏ„(dn) = AUCÏ„ / Dose. To assess the relationship between the PK parameters and the dose, dose normalized AUCÏ„ was plotted against dose, and included individual participant values and the geometric means for each dose.
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Cmax (MAD Period Day 10)
Cmax was summarized by dosing regimen and period. It was observed directly from data.
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Cmax(dn) (MAD Period Day 10)
Cmax(dn) = Cmax / dose. To assess the relationship between Cmax and dose, dose normalized Cmax was plotted against dose, and included individual participant values and the geometric means for each dose.
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Tmax (MAD Period Day 10)
Tmax was summarized by dosing regimen and period. It was observed directly from data as time of first occurrence.
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Average Concentration at Steady State (Cav) (MAD Period Day 10)
Cav = AUCÏ„,ss / Ï„, where ss means 'at steady state', and where the dosing interval Ï„ was 24 hours for QD dosing and 12 hours for BID dosing. Cav was summarized by dosing regimen and period.
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Lowest Concentration Observed During the Dosing Interval Ï„ (Cmin) (MAD Period Day 10)
Cmin was observed directly from data. It was summarized by dosing regimen and period. Dosing interval was the interval Ï„ between administration of doses of drug. In this study, the dosing interval Ï„ was 24 hours for QD dosing and 12 hours for BID dosing.
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Terminal Elimination Half-Life ((t½) (MAD Period Day 10)
t1/2 was summarized by dosing regimen and period. It was determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24,48,72,96,168 hours post-dose
MRT (MAD Period Day 10)
MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from time 0 to infinity.
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24,48,72,96,168 hours post-dose
Peak Trough Ratio (PTR) (MAD Period Day 10)
PTR = Cmax,ss / Cmin,ss, where ss means 'at steady state'. It was summarized by dosing regimen and period.
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Observed Accumulation Ratio Based on AUC (Rac) (MAD Period Day 10)
Rac = AUCÏ„,ss / AUCÏ„,sd, where ss means 'at steady state' and sd 'single dose'. In this study, Rac = AUCÏ„(Day 10) / AUCÏ„(Day 1). Rac was summarized by dosing regimen and period.
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Observed Accumulation Ratio Based on Cmax (Rac,Cmax) (MAD Period Day 10)
Rac,Cmax = Cmax,ss / Cmax,sd, where ss means 'at steady state' and sd 'single dose'. In this study, Rac,Cmax = Cmax(Day10) / Cmax(Day 1). Rac,Cmax was summarized by dosing regimen and period.
Days 1 and 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Vz/F (MAD Period Day 10)
Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
CL/F (MAD Period Day 10)
CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Cumulative Amount of Drug Recovered Unchanged in Urine From Time 0 to the Dosing Interval τ Hours Post-Dose (Aeτ) (MAD Period Day 10)
Dosing interval was the interval τ between administration of doses of drug. In this study, the dosing interval τ was 24 hours for QD dosing and 12 hours for BID dosing. Aeτ = Sum of [urine concentration * sample volume] for each collection interval. Aer was summarized by dosing regimen and period.
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Percentage of Dose Recovered Unchanged in Urine From Time 0 to the Dosing Interval τ Hours Post-Dose (Aeτ%) (MAD Period Day 10)
Dosing interval was the interval τ between administration of doses of drug. In this study, the dosing interval τ was 24 hours for QD dosing and 12 hours for BID dosing. Aeτ% = Aeτ / Dose * 100. Aeτ%was summarized by dosing regimen and period.
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Renal Clearance (Clr) (MAD Period Day 10)
Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Aeτ) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCτ), where dosing interval is 24 hours for QD dosing and 12 hours for BID dosing.
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
AUCÏ„ (Psoriasis Cohorts)
AUCÏ„ was summarized by dosing regimen and period. It was determined by linear/log trapezoidal method.
Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
AUCÏ„(dn) (Psoriasis Cohorts)
AUCÏ„(dn) = AUCÏ„ / Dose. To assess the relationship between the PK parameters and the dose, dose normalized AUCÏ„ was plotted against dose, and included individual participant values and the geometric means for each dose.
Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
Cmax (Psoriasis Cohorts)
Cmax was summarized by dosing regimen and period. It was observed directly from data.
Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
Cmax(dn) (Psoriasis Cohorts)
Cmax was summarized by dosing regimen and period. It was observed directly from data.
Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
Tmax (Psoriasis Cohorts)
Tmax was summarized by dosing regimen and period. It was observed directly from data as time of first occurrence.
Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
Cav (Psoriasis Cohorts)
Cav = AUCÏ„,ss / Ï„, where ss means 'at steady state'. Cav was summarized by dosing regimen and period.
Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
Cmin (Psoriasis Cohorts)
Cmin was observed directly from data. It was summarized by dosing regimen and period.
Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
t1/2 was summarized by dosing regimen and period. It was determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.
Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24,168 hours post-dose
MRT (Psoriasis Cohorts)
MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from time 0 to infinity.
Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24,168 hours post-dose
PTR (Psoriasis Cohorts)
PTR = Cmax,ss / Cmin,ss, it was summarized by dosing regimen and period.
Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
Vz/F (Psoriasis Cohorts)
Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
CL/F (Psoriasis Cohorts)
CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 28
Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease.
Baseline and Day 28
During SAD period (Period 1), healthy participants received placebo matching PF-06826647 30, 100, 400, or 1600 mg SD cohort, respectively, in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In MAD period (Period 2), these participants received placebo matching PF-06826647 30, 100, 400, or 1600 mg once daily (QD) cohort, respectively, for 10 days with standard meal.
FG002
PBO QD MAD Japanese Cohort (JP)
During the MAD period (Period 2), Japanese healthy participants received placebo matching PF-06826647 400 mg QD MAD JP cohort with standard meal. MAD period duration was 28 days.
FG003
PBO Twice Daily (BID)
During the MAD period (Period 2), healthy participants received placebo matching PF-06826647 200 mg BID cohort with standard meal.
FG004
PF-06826647 3 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state. SAD period duration was 8 days.
FG005
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state. SAD period duration was 8 days.
FG006
PF-06826647 30 mg SAD -> 30 mg QD MAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal. SAD period duration was 8 days and MAD period duration was 28 days.
FG007
PF-06826647 100 mg SAD -> 100 mg QD MAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In the MAD period (Period 2), these healthy participants 4 received PF-06826647 100 mg QD for 10 days with standard meal. SAD period duration was 8 days and MAD period duration was 28 days.
FG008
PF-06826647 400 mg SAD -> 400 mg QD MAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In the MAD period (Period 2), these healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. SAD period duration was 8 days and MAD period duration was 28 days. SAD period duration was 8 days and MAD period duration was 28 days.
FG009
PF-06826647 1600 mg SAD -> 1200 mg QD MAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal. SAD period duration was 8 days and MAD period duration was 28 days.
FG010
PF-06826647 200 mg BID
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal. MAD period duration was 28 days.
FG011
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
FG012
PBO QD Psoriasis Cohort (PSO)
In the psoriasis placebo cohorts, psoriasis participants received placebo matching PF-06826647 400, or 100 mg QD cohort, respectively, for 28 days with standard meal. Psoriasis cohorts duration was 84 days, safety and AE evaluations lasted up to Day 84, while vital signs, physical, and laboratory abnormality evaluations lasted up to Day 56.
FG013
PF-06826647 400 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 400 mg QD for 28 days with standard meal. Psoriasis cohorts duration was 84 days, safety and AE evaluations lasted up to Day 84, while vital signs, physical, and laboratory abnormality evaluations lasted up to Day 56.
FG014
PF-06826647 100 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohorts duration was 84 days, safety and AE evaluations lasted up to Day 84, while vital signs, physical, and laboratory abnormality evaluations lasted up to Day 56.
FG0004 subjects
FG0019 subjects
FG0021 subjects
FG0032 subjects
FG0046 subjects
FG0056 subjects
FG0068 subjects
FG0077 subjects
FG0088 subjects
FG0096 subjects
FG0107 subjects
FG0115 subjects
FG01214 subjects
FG01315 subjects
FG01411 subjects
COMPLETED
FG0004 subjects
FG0019 subjects
FG0021 subjects
FG0031 subjects
FG0046 subjects
FG0056 subjects
FG0067 subjects
FG0077 subjects
FG0088 subjects
FG0096 subjects
FG0106 subjects
FG0115 subjects
FG01212 subjects
FG01311 subjects
FG0149 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0101 subjects
FG0110 subjects
FG0122 subjects
FG0134 subjects
FG0142 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0131 subjects
FG0140 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
No Longer Meets Eligibility Criteria
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
All enrolled participants who received at least 1 dose of study medication.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo (PBO) SAD (3 mg, 10 mg)
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, or 10 mg single dose (SD) cohort in fasted state.
BG001
PBO SAD Followed by (->) PBO QD MAD
During SAD period (Period 1), healthy participants received placebo matching PF-06826647 30, 100, 400, or 1600 mg SD cohort, respectively, in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In MAD period (Period 2), these participants received placebo matching PF-06826647 30, 100, 400, or 1600 mg once daily (QD) cohort, respectively, for 10 days with standard meal.
BG002
PBO QD MAD Japanese Cohort (JP)
During the MAD period (Period 2), Japanese healthy participants received placebo matching PF-06826647 400 mg QD MAD JP cohort with standard meal. MAD period duration was 28 days.
BG003
PBO BID
During the MAD period (Period 2), healthy participants received placebo matching PF-06826647 200 mg BID cohort with standard meal.
BG004
PF-06826647 3 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state. SAD period duration was 8 days.
BG005
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state. SAD period duration was 8 days.
BG006
PF-06826647 30 mg SAD -> 30 mg QD MAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal. SAD period duration was 8 days and MAD period duration was 28 days.
BG007
PF-06826647 100 mg SAD -> 100 mg QD MAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In the MAD period (Period 2), these healthy participants 4 received PF-06826647 100 mg QD for 10 days with standard meal. SAD period duration was 8 days and MAD period duration was 28 days.
BG008
PF-06826647 400 mg SAD -> 400 mg QD MAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In the MAD period (Period 2), these healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. SAD period duration was 8 days and MAD period duration was 28 days. SAD period duration was 8 days and MAD period duration was 28 days.
BG009
PF-06826647 1600 mg SAD -> 1200 mg QD MAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state. At least 14 days separated the beginning of the SAD and MAD periods. In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal. SAD period duration was 8 days and MAD period duration was 28 days.
BG010
PF-06826647 200 mg BID
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal. MAD period duration was 28 days.
BG011
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
BG012
PBO QD Psoriasis Cohort (PSO)
In the psoriasis placebo cohorts, psoriasis participants received placebo matching PF-06826647 400, or 100 mg QD cohort, respectively, for 28 days with standard meal. Psoriasis cohorts duration was 84 days, safety and AE evaluations lasted up to Day 84, while vital signs, physical, and laboratory abnormality evaluations lasted up to Day 56.
BG013
PF-06826647 400 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 400 mg QD for 28 days with standard meal. Psoriasis cohorts duration was 84 days, safety and AE evaluations lasted up to Day 84, while vital signs, physical, and laboratory abnormality evaluations lasted up to Day 56.
BG014
PF-06826647 100 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohorts duration was 84 days, safety and AE evaluations lasted up to Day 84, while vital signs, physical, and laboratory abnormality evaluations lasted up to Day 56.
BG015
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG0019
BG0021
BG0032
BG0046
BG0056
BG0068
BG0077
BG0088
BG0096
BG0107
BG0115
BG01214
BG01315
BG01411
BG015109
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00038.5± 12.23
BG00142.2± 10.84
BG00234.0± NAonly 1 participant in this cohort
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0011
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
BG0015
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
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
Primary
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period)
Maximum absolute values and changes from baseline for vital signs (for supine systolic/diastolic blood pressure [BP] and supine pulse rate [PR]) were summarized descriptively by treatment. Numbers of participants meeting the categorical criteria were provided.
Number of participants in PBO SAD cohorts = number of participants in [PBO SAD (3mg, 10mg)] cohorts + number of participants in [PBO SAD -> PBO QD MAD] cohorts.
The analysis population included the healthy participants who received study treatment and who had the safety parameters in the SAD Period. MAD and Psoriasis Cohorts data were not included.
Posted
Count of Participants
Participants
Baseline up to Day 8
ID
Title
Description
OG000
PBO SAD
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in [PBO SAD (3mg, 10mg)] cohorts + participants in [PBO SAD -> PBO QD] cohorts.
OG001
PF-06826647 3 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
OG002
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
OG003
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
OG004
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
OG005
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
OG006
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
Units
Counts
Participants
OG00013
OG0016
OG0026
OG003
Title
Denominators
Categories
Supine diastolic BP Value <50 mmHg
Title
Measurements
OG0002
OG0012
OG0021
OG003
Primary
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period)
Maximum absolute values and changes from baseline for vital signs (for supine systolic/diastolic blood pressure and supine pulse rate) were summarized descriptively by treatment. Numbers of participants meeting the categorical criteria were provided.
The analysis population included the healthy participants who received study treatment in the MAD Period. The PBO QD MAD sequence is comprised of both non-Japanese and Japanese participants. The non-Japanese participants had completed the SAD period and continued into the MAD period. The Japanese participants took part only in the MAD period.
Posted
Count of Participants
Participants
Baseline up to Day 28
ID
Title
Description
OG000
PBO QD MAD (JP PBO Included)
This arm includes both non-Japanese and Japanese participants. In MAD period (Period 2), the non-Japanese participants received placebo matching PF-06826647 30, 100, 400, or 1200 mg once daily (QD) cohort while the Japanese participants received placebo matching PF-06826647 400 mg QD Japanese cohort, both for 10 days with standard meal.
OG001
PBO BID
During the MAD period (Period 2), healthy participants received placebo matching PF-06826647 200 mg BID cohort with standard meal.
OG002
Primary
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
Maximum absolute values and changes from baseline for vital signs (for supine systolic/diastolic blood pressure and supine pulse rate) were summarized descriptively by treatment. Numbers of participants meeting the categorical criteria were provided.
The analysis population included the psoriasis participants who received study treatment and who had the safety parameters in the Psoriasis Cohorts. Data in SAD/MAD Periods were not included.
Posted
Count of Participants
Participants
Baseline up to Day 56
ID
Title
Description
OG000
PBO QD PSO
In the psoriasis (PSO) cohorts, psoriasis participants received placebo matching PF-06826647 400, or 100 mg QD PSO cohort for 28 days with standard meal.
OG001
PF-06826647 400 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 400 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
OG002
PF-06826647 100 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
Primary
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period)
Physical examinations were conducted by a physician, trained physician assistant, or nurse practitioner as acceptable according to local regulation. A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The examination assessed the participants for any potential changes in general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. Findings were considered to be clinically significant based on investigator's decision.
Number of participants in PBO SAD cohorts = number of participants in [PBO SAD (3mg, 10mg)] cohorts + number of participants in [PBO SAD -> PBO QD MAD] cohorts.
The analysis population included the healthy participants who received study treatment and who had the safety parameters in the SAD Period. MAD and Psoriasis Cohorts data were not included.
Posted
Count of Participants
Participants
Baseline up to Day 8
ID
Title
Description
OG000
PBO SAD
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in [PBO SAD (3mg, 10mg)] cohorts + participants in [PBO SAD -> PBO QD] cohorts.
OG001
PF-06826647 3 mg SAD
Primary
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period)
Physical examinations were conducted by a physician, trained physician assistant, or nurse practitioner as acceptable according to local regulation. A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The examination assessed the participants for any potential changes in general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. Findings were considered to be clinically significant based on investigator's decision.
The analysis population included the healthy participants who received study treatment in the MAD Period. The PBO QD MAD sequence is comprised of both non-Japanese and Japanese participants. The non-Japanese participants had completed the SAD period and continued into the MAD period. The Japanese participants took part only in the MAD period.
Posted
Count of Participants
Participants
Baseline up to Day 28
ID
Title
Description
OG000
PBO QD MAD
This arm includes both non-Japanese and Japanese participants. In MAD period (Period 2), the non-Japanese participants received placebo matching PF-06826647 30, 100, 400, or 1200 mg once daily (QD) cohort while the Japanese participants received placebo matching PF-06826647 400 mg QD Japanese cohort, both for 10 days with standard meal.
OG001
PBO BID
Primary
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
Physical examinations were conducted by a physician, trained physician assistant, or nurse practitioner as acceptable according to local regulation. A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The examination assessed the participants for any potential changes in general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. Findings were considered to be clinically significant based on investigator's decision.
The analysis population included the psoriasis participants who received study treatment and who had the safety parameters in the Psoriasis Cohorts. Data in SAD/MAD Periods were not included.
Posted
Count of Participants
Participants
Baseline up to Day 56
ID
Title
Description
OG000
PBO QD PSO
In the psoriasis (PSO) cohorts, psoriasis participants received placebo matching PF-06826647 400, or 100 mg QD PSO cohort for 28 days with standard meal.
OG001
PF-06826647 400 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 400 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
OG002
Primary
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period)
ECG endpoints and changes from baseline (QTcF, PR and QRS) were summarized descriptively by cohort and treatment using pre-defined categories. Numbers of participants meeting the categorical criteria were provided. All planned and unplanned post-dose time points were counted in these categorical summaries. Categorical summarization criteria for ECG were as follows: 1) QTcF maximum absolute value ≥450 and <480 millisecond (msec), ≥480 and <500 msec. ≥500 msec; 2) QTcF maximum increase ≥30 and <60 msec, ≥60 msec; 3) PR maximum absolute value ≥300 msec; 4) PR maximum increases from baseline ≥25% if baseline >200 msec, ≥50% if baseline ≤200 msec; 5) QRS maximum absolute value ≥140 msec; 6) QRS maximum increase from baseline ≥50%.
Number of participants in PBO SAD cohorts = number of participants in [PBO SAD (3mg, 10mg)] cohorts + number of participants in [PBO SAD -> PBO QD MAD] cohorts.
The analysis population included the healthy participants who received study treatment and who had the safety parameters in the SAD Period. MAD and Psoriasis Cohorts data were not included.
Posted
Count of Participants
Participants
Baseline up to Day 8
ID
Title
Description
OG000
PBO SAD
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in [PBO SAD (3mg, 10mg)] cohorts + participants in [PBO SAD -> PBO QD] cohorts.
OG001
Primary
Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period)
ECG endpoints and changes from baseline (QTcF, PR and QRS) were summarized descriptively by cohort and treatment using pre-defined categories. Numbers of participants meeting the categorical criteria were provided. All planned and unplanned post-dose time points were counted in these categorical summaries. Categorical summarization criteria for ECG were as follows: 1) QTcF maximum absolute value ≥450 and <480 millisecond (msec), ≥480 and <500 msec. ≥500 msec; 2) QTcF maximum increase ≥30 and <60 msec, ≥60 msec; 3) PR maximum absolute value ≥300 msec; 4) PR maximum increases from baseline ≥25% if baseline >200 msec, ≥50% if baseline ≤200 msec; 5) QRS maximum absolute value ≥140 msec; 6) QRS maximum increase from baseline ≥50%.
The analysis population included the healthy participants who received study treatment in the MAD Period. The PBO QD MAD sequence is comprised of both non-Japanese and Japanese participants. The non-Japanese participants had completed the SAD period and continued into the MAD period. The Japanese participants took part only in the MAD period.
Posted
Count of Participants
Participants
Baseline up to Day 28
ID
Title
Description
OG000
PBO QD MAD
This arm includes both non-Japanese and Japanese participants. In MAD period (Period 2), the non-Japanese participants received placebo matching PF-06826647 30, 100, 400, or 1200 mg once daily (QD) cohort while the Japanese participants received placebo matching PF-06826647 400 mg QD Japanese cohort, both for 10 days with standard meal.
OG001
Primary
Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
ECG endpoints and changes from baseline (QTcF, PR and QRS) were summarized descriptively by cohort and treatment using pre-defined categories. Numbers of participants meeting the categorical criteria were provided. All planned and unplanned post-dose time points were counted in these categorical summaries. Categorical summarization criteria for ECG were as follows: 1) QTcF maximum absolute value ≥450 and <480 millisecond (msec), ≥480 and <500 msec. ≥500 msec; 2) QTcF maximum increase ≥30 and <60 msec, ≥60 msec; 3) PR maximum absolute value ≥300 msec; 4) PR maximum increases from baseline ≥25% if baseline >200 msec, ≥50% if baseline ≤200 msec; 5) QRS maximum absolute value ≥140 msec; 6) QRS maximum increase from baseline ≥50%.
The analysis population included the psoriasis participants who received study treatment and who had the safety parameters in the Psoriasis Cohorts. Data in SAD/MAD Periods were not included.
Posted
Count of Participants
Participants
Baseline up to Day 56
ID
Title
Description
OG000
PBO QD PSO
In the psoriasis (PSO) cohorts, psoriasis participants received placebo matching PF-06826647 400, or 100 mg QD PSO cohort for 28 days with standard meal.
OG001
PF-06826647 400 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 400 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period)
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. All events occurring following start of the treatment or increasing in severity were counted as treatment emergent. Events that occurred in a non-treatment period (eg, washout or follow-up) were counted as treatment emergent and attributed to the previous treatment taken. For each event, the investigator pursued and obtained adequate information both to determine the outcome and to assess whether it meets the criteria for classification as an SAE.
PBO SAD cohorts = [PBO SAD (3mg, 10mg)] cohorts + [PBO SAD -> PBO QD MAD] cohorts.
The analysis population included the healthy participants who received study treatment and who had the safety parameters in the SAD Period. MAD and Psoriasis Cohorts data were not included.
Posted
Count of Participants
Participants
Baseline up to Day 8
ID
Title
Description
OG000
PBO SAD
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in [PBO SAD (3mg, 10mg)] cohorts + participants in [PBO SAD -> PBO QD] cohorts.
Primary
Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period)
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. All events occurring following start of the treatment or increasing in severity were counted as treatment emergent. Events that occurred in a non-treatment period (eg, washout or follow-up) were counted as treatment emergent and attributed to the previous treatment taken. For each event, the investigator pursued and obtained adequate information both to determine the outcome and to assess whether it meets the criteria for classification as an SAE.
The analysis population included the healthy participants who received study treatment in the MAD Period. The PBO QD MAD sequence is comprised of both non-Japanese and Japanese participants. The non-Japanese participants had completed the SAD period and continued into the MAD period. The Japanese participants took part only in the MAD period.
Posted
Count of Participants
Participants
Baseline up to Day 28
ID
Title
Description
OG000
PBO QD MAD
This arm includes both non-Japanese and Japanese participants. In MAD period (Period 2), the non-Japanese participants received placebo matching PF-06826647 30, 100, 400, or 1200 mg once daily (QD) cohort while the Japanese participants received placebo matching PF-06826647 400 mg QD Japanese cohort, both for 10 days with standard meal.
Primary
Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts)
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. All events occurring following start of the treatment or increasing in severity were counted as treatment emergent. Events that occurred in a non-treatment period (eg, washout or follow-up) were counted as treatment emergent and attributed to the previous treatment taken. For each event, the investigator pursued and obtained adequate information both to determine the outcome and to assess whether it meets the criteria for classification as an SAE.
The analysis population included the psoriasis participants who received study treatment and who had the safety parameters in the Psoriasis Cohorts. Data in SAD/MAD Periods were not included.
Posted
Count of Participants
Participants
Baseline up to Day 84
ID
Title
Description
OG000
PBO QD PSO
In the psoriasis (PSO) cohorts, psoriasis participants received placebo matching PF-06826647 400, or 100 mg QD PSO cohort for 28 days with standard meal.
OG001
PF-06826647 400 mg QD PSO
Primary
Number of Participants With Laboratory Abnormalities (SAD Period)
Laboratory data were listed and summarized by treatment in accordance with the sponsor reporting standards. Parameters for laboratory abnormalities evaluation included: erythrocyte mean corpuscular volume (Ery. MCV), erythrocyte mean corpuscular hemoglobin (Ery. MCH), reticulocytes/erythrocytes (%), limphocytes, eosinophils, bilirubin, aspartate aminotransferase (AST), urate, high-density lipoproteins (HDL) cholesterol, low-density lipoproteins (LDL) cholesterol, triglycerides, cholesterol, ketones, nitrite, leukocyte esterase, epithelial cells, urinalysis-bacteria.
Number of participants in PBO SAD cohorts = number of participants in [PBO SAD (3mg, 10mg)] cohorts + number of participants in [PBO SAD -> PBO QD MAD] cohorts.
The analysis population included the healthy participants who received study treatment and who had the safety parameters in the SAD Period. MAD and Psoriasis Cohorts data were not included.
Posted
Count of Participants
Participants
Baseline up to Day 8
ID
Title
Description
OG000
PBO SAD
During the SAD period (Period 1), healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg single dose (SD) cohort in fasted state. Participants in PBO SAD cohorts = participants in [PBO SAD (3mg, 10mg)] cohorts + participants in [PBO SAD -> PBO QD] cohorts.
OG001
PF-06826647 3 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
Primary
Number of Participants With Laboratory Abnormalities (MAD Period)
Laboratory data were listed and summarized by treatment in accordance with the sponsor reporting standards. Parameters and corresponding primary criteria for laboratory abnormalities evaluation included: Ery. MCV <0.9 × LLN, Ery. Mean corpuscular hemoglobin (Ery. MCH) <0.9 × LLN or >1.1 ULN, reticulocytes/erythrocytes (%) >1.5 × ULN, lymphocytes <0.8 × LLN or >1.2 × ULN, neutrophils <0.8 × LLN, eosinophils >1.2 × ULN, bilirubin >1.5 × ULN, urate >1.2 × ULN, HDL cholesterol <0.8 × LLN, LDL cholesterol >1.2 × ULN, triglycerides >1.3 × ULN, bicarbonate >1.1 × ULN, cholesterol >1.3 × ULN, urine glucose ≥1, urine hemoglobin ≥1, nitrite ≥1, leukocyte esterase ≥1, epithelial cells ≥6/LPF, urinalysis-casts >1/LPF, urinalysis-bacteria >20/HPF, urine 24 hours creatinine >1.1 × ULN.
The analysis population included the healthy participants who received study treatment in the MAD Period. The PBO QD MAD sequence is comprised of both non-Japanese and Japanese participants. The non-Japanese participants had completed the SAD period and continued into the MAD period. The Japanese participants took part only in the MAD period.
Posted
Count of Participants
Participants
Baseline up to Day 28
ID
Title
Description
OG000
PBO QD MAD
This arm includes both non-Japanese and Japanese participants. In MAD period (Period 2), the non-Japanese participants received placebo matching PF-06826647 30, 100, 400, or 1200 mg once daily (QD) cohort while the Japanese participants received placebo matching PF-06826647 400 mg QD Japanese cohort, both for 10 days with standard meal.
Primary
Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)
The analysis population included the psoriasis participants who received study treatment and who had the safety parameters in the Psoriasis Cohorts. Data in SAD/MAD Periods were not included.
Posted
Count of Participants
Participants
Baseline up to Day 56
ID
Title
Description
OG000
PBO QD PSO
In the psoriasis (PSO) cohorts, psoriasis participants received placebo matching PF-06826647 400, or 100 mg QD PSO cohort for 28 days with standard meal.
OG001
PF-06826647 400 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 400 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
Primary
Change in 24 Hour Creatinine Clearance From Day -1 on Day 10 (MAD Period)
Change in 24-hour creatinine clearance at Day 10 from Day -1 (baseline) during the MAD was presented by treatment group.
The analysis population included the healthy participants who received study treatment in the MAD Period. The PBO QD MAD sequence is comprised of both non-Japanese and Japanese participants. The non-Japanese participants had completed the SAD period and continued into the MAD period. The Japanese participants took part only in the MAD period.
Posted
Mean
Standard Deviation
milliliters per minute (mL/min)
Day -1 and Day 10
ID
Title
Description
OG000
PBO QD MAD
This arm includes both non-Japanese and Japanese participants. In MAD period (Period 2), the non-Japanese participants received placebo matching PF-06826647 30, 100, 400, or 1200 mg once daily (QD) cohort while the Japanese participants received placebo matching PF-06826647 400 mg QD Japanese cohort, both for 10 days with standard meal.
OG001
PBO BID
During the MAD period (Period 2), healthy participants received placebo matching PF-06826647 200 mg BID cohort with standard meal.
OG002
PF-06826647 30 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal.
Secondary
Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) (SAD Period)
AUCinf = Area under the plasma concentration versus time curve (AUC) from time 0 (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
The analysis population included the healthy participants who received study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms*hours per mL (ng*hr/mL)
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
ID
Title
Description
OG000
PF-06826647 3 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
OG001
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
OG002
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
AUCinf = Area under the plasma concentration versus time curve (AUC) from time 0 (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf). AUCinf(dn) = AUCinf / dose. Dose normalized AUC values of PF-06826647 was plotted against dose and included individual participant values and the geometric means for each dose. These plots were used to help understand the relationship between the plasma PK parameters and dose.
The analysis population included the healthy participants who received study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*hr/mL/mg
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
ID
Title
Description
OG000
PF-06826647 3 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
OG001
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
OG002
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
Secondary
Area Under the Concentration-Time Profile From Time 0 to 24 Hours (AUC24) (SAD Period)
AUC24 was summarized by dosing regimen and period. It was determined by linear/log trapezoidal method.
The analysis population included the healthy participants who received study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*hr/mL
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 3 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
OG001
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
OG002
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
OG003
PF-06826647 100 mg SAD
Secondary
Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) (SAD Period)
AUClast was summarized by dosing regimen and period. It was determined by linear/log trapezoidal method.
The analysis population included the healthy participants who received study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*hr/mL
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
ID
Title
Description
OG000
PF-06826647 3 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
OG001
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
OG002
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
AUClast(dn) = AUClast / dose. Dose normalized AUC values of PF-06826647 were plotted against dose and included individual participant values and the geometric means for each dose. These plots was used to help understand the relationship between the plasma PK parameters and dose.
The analysis population included the healthy participants who received study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*hr/mL/mg
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
ID
Title
Description
OG000
PF-06826647 3 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
OG001
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
OG002
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
OG003
Secondary
Maximum Plasma Concentration (Cmax) (SAD Period)
Cmax was summarized by dosing regimen and period. It was observed directly from data.
The analysis population included the healthy participants who received study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
ID
Title
Description
OG000
PF-06826647 3 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
OG001
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
OG002
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
OG003
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
Secondary
Dose Normalized Cmax (Cmax[dn]) (SAD Period)
Cmax(dn) = Cmax / dose. To assess the relationship between Cmax and dose, dose normalized Cmax was plotted against dose, and included individual participant values and the geometric means for each dose.
The analysis population included healthy participants who received the study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL/mg
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
ID
Title
Description
OG000
PF-06826647 3 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
OG001
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
OG002
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
OG003
PF-06826647 100 mg SAD
Secondary
Time for Cmax (Tmax) (SAD Period)
Tmax was summarized by dosing regimen and period. It was observed directly from data as time of first occurrence.
The analysis population included healthy participants who received the study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.
Posted
Median
Full Range
hours (hr)
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
ID
Title
Description
OG000
PF-06826647 3 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
OG001
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
OG002
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
OG003
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
t1/2 was summarized by dosing regimen and period. It was determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.
The analysis population included the healthy participants who received study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.
Posted
Mean
Standard Deviation
hours (hr)
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
ID
Title
Description
OG000
PF-06826647 3 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
OG001
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
OG002
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
OG003
Secondary
Mean Residence Time (MRT) (SAD Period)
MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from time 0 to infinity.
The analysis population included healthy participants who received the study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours (hr)
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
ID
Title
Description
OG000
PF-06826647 3 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
OG001
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
OG002
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
OG003
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
Secondary
Apparent Volume of Distribution (Vz/F) (SAD Period)
Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
The analysis population included the healthy participants who received study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
liters (L)
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
ID
Title
Description
OG000
PF-06826647 3 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
OG001
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
OG002
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
OG003
Secondary
Apparent Clearance (CL/F) (SAD Period)
CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
The analysis population included the healthy participants who received study treatment and who had the PK parameter in the SAD Period. MAD and Psoriasis Cohorts data were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
liters per hour (L/hr)
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
ID
Title
Description
OG000
PF-06826647 3 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
OG001
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
OG002
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
Secondary
Area Under the Plasma Concentration-Time Profile Over the Dosing Interval Ï„ (AUCÏ„) (MAD Period Day 1)
AUCÏ„ was summarized by dosing regimen and period. Dosing interval was the interval Ï„ between administration of doses of drug. In this study, the dosing interval was 24 hours for QD dosing and 12 hours for BID dosing. It was determined by linear/log trapezoidal method.
The analysis population included healthy participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*hr/mL
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 30 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal.
OG001
PF-06826647 100 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 100 mg QD for 10 days with standard meal.
OG002
PF-06826647 200 mg BID MAD
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal.
Secondary
Dose Normalized AUCÏ„ (AUCÏ„[dn]) (MAD Period Day 1)
Area Under the Plasma Concentration-Time Profile over the Dosing interval Ï„ (AUCÏ„). Dosing interval was the interval Ï„ between administration of doses of drug. In this study, the dosing interval Ï„ was 24 hours for QD dosing and 12 hours for BID dosing.
AUCÏ„(dn) = AUCÏ„ / Dose. To assess the relationship between the PK parameters and the dose, dose normalized AUCÏ„ was plotted against dose, and included individual participant values and the geometric means for each dose.
The analysis population included healthy participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*hr/mL/mg
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 30 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal.
OG001
PF-06826647 100 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 100 mg QD for 10 days with standard meal.
OG002
PF-06826647 200 mg BID MAD
Secondary
Cmax (MAD Period Day 1)
Cmax was summarized by dosing regimen and period. It was observed directly from data.
The analysis population included healthy participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 30 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal.
OG001
PF-06826647 100 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 100 mg QD for 10 days with standard meal.
OG002
PF-06826647 200 mg BID MAD
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal.
OG003
PF-06826647 400 QD MAD
Secondary
Cmax(dn) (MAD Period Day 1)
Cmax(dn) = Cmax / dose. To assess the relationship between Cmax and dose, dose normalized Cmax was plotted against dose, and included individual participant values and the geometric means for each dose.
The analysis population included healthy participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL/mg
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 30 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal.
OG001
PF-06826647 100 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 100 mg QD for 10 days with standard meal.
OG002
PF-06826647 200 mg BID MAD
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal.
OG003
Secondary
Tmax (MAD Period Day 1)
Tmax was summarized by dosing regimen and period. It was observed directly from data as time of first occurrence.
The analysis population included healthy participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Posted
Median
Full Range
hours (hr)
Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 30 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal.
OG001
PF-06826647 100 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 100 mg QD for 10 days with standard meal.
OG002
PF-06826647 200 mg BID MAD
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal.
OG003
PF-06826647 400 QD MAD
Secondary
AUCÏ„ (MAD Period Day 10)
AUCÏ„ was summarized by dosing regimen and period. Dosing interval was the interval Ï„ between administration of doses of drug. In this study, the dosing interval was 24 hours for QD dosing and 12 hours for BID dosing. It was determined by linear/log trapezoidal method.
The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*hr/mL
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 30 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal.
OG001
PF-06826647 100 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 100 mg QD for 10 days with standard meal.
OG002
PF-06826647 200 mg BID MAD
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal.
Secondary
AUCÏ„(dn) (MAD Period Day 10)
Area Under the Plasma Concentration-Time Profile over the Dosing interval Ï„ (AUCÏ„). Dosing interval was the interval Ï„ between administration of doses of drug. In this study, the dosing interval Ï„ was 24 hours for QD dosing and 12 hours for BID dosing.
AUCÏ„(dn) = AUCÏ„ / Dose. To assess the relationship between the PK parameters and the dose, dose normalized AUCÏ„ was plotted against dose, and included individual participant values and the geometric means for each dose.
The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*hr/mL/mg
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 30 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal.
OG001
PF-06826647 100 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 100 mg QD for 10 days with standard meal.
OG002
PF-06826647 200 mg BID MAD
Secondary
Cmax (MAD Period Day 10)
Cmax was summarized by dosing regimen and period. It was observed directly from data.
The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 30 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal.
OG001
PF-06826647 100 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 100 mg QD for 10 days with standard meal.
OG002
PF-06826647 200 mg BID MAD
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal.
OG003
PF-06826647 400 QD MAD
Secondary
Cmax(dn) (MAD Period Day 10)
Cmax(dn) = Cmax / dose. To assess the relationship between Cmax and dose, dose normalized Cmax was plotted against dose, and included individual participant values and the geometric means for each dose.
The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL/mg
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 30 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal.
OG001
PF-06826647 100 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 100 mg QD for 10 days with standard meal.
OG002
PF-06826647 200 mg BID MAD
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal.
OG003
Secondary
Tmax (MAD Period Day 10)
Tmax was summarized by dosing regimen and period. It was observed directly from data as time of first occurrence.
The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Posted
Median
Full Range
hours (hr)
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 30 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal.
OG001
PF-06826647 100 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 100 mg QD for 10 days with standard meal.
OG002
PF-06826647 200 mg BID MAD
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal.
OG003
PF-06826647 400 QD MAD
Secondary
Average Concentration at Steady State (Cav) (MAD Period Day 10)
Cav = AUCÏ„,ss / Ï„, where ss means 'at steady state', and where the dosing interval Ï„ was 24 hours for QD dosing and 12 hours for BID dosing. Cav was summarized by dosing regimen and period.
The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 30 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal.
OG001
PF-06826647 100 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 100 mg QD for 10 days with standard meal.
OG002
PF-06826647 200 mg BID MAD
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal.
Secondary
Lowest Concentration Observed During the Dosing Interval Ï„ (Cmin) (MAD Period Day 10)
Cmin was observed directly from data. It was summarized by dosing regimen and period. Dosing interval was the interval Ï„ between administration of doses of drug. In this study, the dosing interval Ï„ was 24 hours for QD dosing and 12 hours for BID dosing.
The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 30 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal.
OG001
PF-06826647 100 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 100 mg QD for 10 days with standard meal.
OG002
PF-06826647 200 mg BID MAD
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal.
Secondary
Terminal Elimination Half-Life ((t½) (MAD Period Day 10)
t1/2 was summarized by dosing regimen and period. It was determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.
The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Posted
Mean
Standard Deviation
hours (hr)
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24,48,72,96,168 hours post-dose
ID
Title
Description
OG000
PF-06826647 30 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal.
OG001
PF-06826647 100 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 100 mg QD for 10 days with standard meal.
OG002
PF-06826647 200 mg BID MAD
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal.
Secondary
MRT (MAD Period Day 10)
MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from time 0 to infinity.
The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours (hr)
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24,48,72,96,168 hours post-dose
ID
Title
Description
OG000
PF-06826647 30 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal.
OG001
PF-06826647 100 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 100 mg QD for 10 days with standard meal.
OG002
PF-06826647 200 mg BID MAD
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal.
OG003
PF-06826647 400 QD MAD
Secondary
Peak Trough Ratio (PTR) (MAD Period Day 10)
PTR = Cmax,ss / Cmin,ss, where ss means 'at steady state'. It was summarized by dosing regimen and period.
The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 30 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal.
OG001
PF-06826647 100 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 100 mg QD for 10 days with standard meal.
OG002
PF-06826647 200 mg BID MAD
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal.
OG003
PF-06826647 400 QD MAD
Secondary
Observed Accumulation Ratio Based on AUC (Rac) (MAD Period Day 10)
Rac = AUCÏ„,ss / AUCÏ„,sd, where ss means 'at steady state' and sd 'single dose'. In this study, Rac = AUCÏ„(Day 10) / AUCÏ„(Day 1). Rac was summarized by dosing regimen and period.
The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 30 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal.
OG001
PF-06826647 100 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 100 mg QD for 10 days with standard meal.
OG002
PF-06826647 200 mg BID MAD
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal.
Secondary
Observed Accumulation Ratio Based on Cmax (Rac,Cmax) (MAD Period Day 10)
Rac,Cmax = Cmax,ss / Cmax,sd, where ss means 'at steady state' and sd 'single dose'. In this study, Rac,Cmax = Cmax(Day10) / Cmax(Day 1). Rac,Cmax was summarized by dosing regimen and period.
The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
Days 1 and 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 30 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal.
OG001
PF-06826647 100 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 100 mg QD for 10 days with standard meal.
OG002
PF-06826647 200 mg BID MAD
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal.
Secondary
Vz/F (MAD Period Day 10)
Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
liters (L)
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 30 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal.
OG001
PF-06826647 100 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 100 mg QD for 10 days with standard meal.
OG002
PF-06826647 200 mg BID MAD
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal.
Secondary
CL/F (MAD Period Day 10)
CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
liters per hour (L/hr)
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 30 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal.
OG001
PF-06826647 100 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 100 mg QD for 10 days with standard meal.
OG002
PF-06826647 200 mg BID MAD
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal.
Secondary
Cumulative Amount of Drug Recovered Unchanged in Urine From Time 0 to the Dosing Interval τ Hours Post-Dose (Aeτ) (MAD Period Day 10)
Dosing interval was the interval τ between administration of doses of drug. In this study, the dosing interval τ was 24 hours for QD dosing and 12 hours for BID dosing. Aeτ = Sum of [urine concentration * sample volume] for each collection interval. Aer was summarized by dosing regimen and period.
The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
mg
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 30 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal.
OG001
PF-06826647 100 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 100 mg QD for 10 days with standard meal.
OG002
PF-06826647 200 mg BID MAD
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal.
Secondary
Percentage of Dose Recovered Unchanged in Urine From Time 0 to the Dosing Interval τ Hours Post-Dose (Aeτ%) (MAD Period Day 10)
Dosing interval was the interval τ between administration of doses of drug. In this study, the dosing interval τ was 24 hours for QD dosing and 12 hours for BID dosing. Aeτ% = Aeτ / Dose * 100. Aeτ%was summarized by dosing regimen and period.
The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
Percentage of Dose
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 30 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal.
OG001
PF-06826647 100 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 100 mg QD for 10 days with standard meal.
OG002
PF-06826647 200 mg BID MAD
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal.
Secondary
Renal Clearance (Clr) (MAD Period Day 10)
Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Aeτ) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCτ), where dosing interval is 24 hours for QD dosing and 12 hours for BID dosing.
The analysis population included healthy participants who received study treatment on Day 10 and who had the Day 10 PK parameters in the MAD Period. Data on the other days of MAD Period as well as in SAD and Psoriasis Cohorts were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/hr
Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 30 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal.
OG001
PF-06826647 100 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 100 mg QD for 10 days with standard meal.
OG002
PF-06826647 200 mg BID MAD
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal.
Secondary
AUCÏ„ (Psoriasis Cohorts)
AUCÏ„ was summarized by dosing regimen and period. It was determined by linear/log trapezoidal method.
The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*hr/mL
Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 100 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
OG001
PF-06826647 400 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 400 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
Units
Counts
Participants
Secondary
AUCÏ„(dn) (Psoriasis Cohorts)
AUCÏ„(dn) = AUCÏ„ / Dose. To assess the relationship between the PK parameters and the dose, dose normalized AUCÏ„ was plotted against dose, and included individual participant values and the geometric means for each dose.
The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng*hr/mL/mg
Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 100 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
OG001
PF-06826647 400 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 400 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
Units
Counts
Participants
Secondary
Cmax (Psoriasis Cohorts)
Cmax was summarized by dosing regimen and period. It was observed directly from data.
The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 100 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
OG001
PF-06826647 400 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 400 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
Units
Counts
Participants
Secondary
Cmax(dn) (Psoriasis Cohorts)
Cmax was summarized by dosing regimen and period. It was observed directly from data.
The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL/mg
Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 100 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
OG001
PF-06826647 400 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 400 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
Units
Counts
Participants
Secondary
Tmax (Psoriasis Cohorts)
Tmax was summarized by dosing regimen and period. It was observed directly from data as time of first occurrence.
The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.
Posted
Median
Full Range
hours (hr)
Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 100 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
OG001
PF-06826647 400 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 400 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
Units
Counts
Participants
Secondary
Cav (Psoriasis Cohorts)
Cav = AUCÏ„,ss / Ï„, where ss means 'at steady state'. Cav was summarized by dosing regimen and period.
The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 100 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
OG001
PF-06826647 400 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 400 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
Units
Counts
Participants
Secondary
Cmin (Psoriasis Cohorts)
Cmin was observed directly from data. It was summarized by dosing regimen and period.
The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
ng/mL
Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 100 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
OG001
PF-06826647 400 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 400 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
t1/2 was summarized by dosing regimen and period. It was determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.
The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.
Posted
Mean
Standard Deviation
hours (hr)
Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24,168 hours post-dose
ID
Title
Description
OG000
PF-06826647 100 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
OG001
PF-06826647 400 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 400 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
Units
Counts
Secondary
MRT (Psoriasis Cohorts)
MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from time 0 to infinity.
The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
hours (hr)
Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24,168 hours post-dose
ID
Title
Description
OG000
PF-06826647 100 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
OG001
PF-06826647 400 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 400 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
Units
Counts
Participants
Secondary
PTR (Psoriasis Cohorts)
PTR = Cmax,ss / Cmin,ss, it was summarized by dosing regimen and period.
The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
ratio
Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 100 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
OG001
PF-06826647 400 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 400 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
Units
Counts
Participants
OG000
Secondary
Vz/F (Psoriasis Cohorts)
Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
liters (L)
Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 100 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
OG001
PF-06826647 400 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 400 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
Units
Counts
Participants
Secondary
CL/F (Psoriasis Cohorts)
CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
The analysis population included psoriasis participants who received study treatment on Day 1 and who had the Day 1 PK parameters in the Psoriasis Cohorts. Data on the other days of Psoriasis Cohorts study treatment period, as well as in SAD/MAD Periods were not included.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/hr
Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
ID
Title
Description
OG000
PF-06826647 100 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
OG001
PF-06826647 400 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 400 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
Secondary
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 28
Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease.
The analysis population included psoriasis participants who received the 28-day study treatment and who had the efficacy parameters at Baseline and on Day 28 in the Psoriasis Cohorts. Data in SAD/MAD Periods were not included.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline and Day 28
ID
Title
Description
OG000
PBO QD PSO
In the psoriasis (PSO) cohorts, psoriasis participants received placebo matching PF-06826647 400, or 100 mg QD PSO cohort for 28 days with standard meal.
OG001
PF-06826647 400 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 400 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
OG002
Time Frame
Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.
Description
The requirements for recording safety events on the CRF and for reporting safety events on the Clinical Trial Serious Adverse Event Report Form to Pfizer Safety were delineated for 3 types of events: (1) SAEs; (2) non-serious adverse events (AEs); and (3) exposure to the investigational product under study during pregnancy or breastfeeding, and occupational exposure.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo SAD
During the SAD period (Period 1), the healthy participants received placebo matching PF-06826647 3, 10, 30, 100, 400, or 1600 mg cohort SD cohort in fasted state. SAD period duration was 8 days. (Those placebo participants matching 30, 100, 400, or 1600 SD cohort later continued into MAD period and received the placebo matching 30, 100, 400, or 1200 mg QD cohort, respectively.)
0
13
0
13
1
13
EG001
Placebo QD MAD (JP Placebo Included)
This arm includes both non-Japanese and Japanese participants. In MAD period (Period 2), the non-Japanese participants (they had completed the SAD period) received placebo matching PF-06826647 30, 100, 400, or 1200 mg QD cohort while the Japanese participants (they did not take part in SAD period) received placebo matching PF-06826647 400 mg QD Japanese cohort, both for 10 days with standard meal. MAD period duration was 28 days.
0
9
0
9
2
9
EG002
Placebo BID
Edit During the MAD period (Period 2), the healthy participants received placebo matching PF-06826647 200 mg BID cohort for 10 days with standard meal. MAD period duration was 28 days.
0
2
0
2
0
2
EG003
PF-06826647 3 mg SAD
During the SAD period (Period 1), the healthy participants received PF-06826647 3 mg SD in fasted state. SAD period duration was 8 days.
0
6
0
6
0
6
EG004
PF-06826647 10 mg SAD
During the SAD period (Period 1), the healthy participants received PF-06826647 10 mg SD in fasted state. SAD period duration was 8 days.
0
6
0
6
0
6
EG005
PF-06826647 30 mg SAD
During the SAD period (Period 1), the healthy participants received PF-06826647 30 mg SD in fasted state. SAD period duration was 8 days. (These participants later continued into PF-06826647 30 mg QD in MAD period.)
0
8
0
8
0
8
EG006
PF-06826647 30 mg QD MAD
During the MAD period (Period 2), the healthy participants who had taken PF-06826647 30 mg SD received PF-06826647 30 mg QD for 10 days with standard meal. MAD period duration was 28 days.
0
6
0
6
2
6
EG007
PF-06826647 100 mg SAD
During the SAD period (Period 1), the healthy participants received PF-06826647 100 mg SD in fasted state. SAD period duration was 8 days. (These participants later continued into PF-06826647 100 mg QD in MAD period.)
0
7
0
7
1
7
EG008
PF-06826647 100 mg QD MAD
During the MAD period (Period 2), the healthy participants who had taken PF-06826647 100 mg SD received PF-06826647 100 mg QD for 10 days with standard meal. MAD period duration was 28 days.
0
6
0
6
1
6
EG009
PF-06826647 400 mg SAD
During the SAD period (Period 1), the healthy participants received PF-06826647 400 mg SD in fasted state. SAD period duration was 8 days. (These participants later continued into PF-06826647 400 mg QD in MAD period.)
0
8
0
8
0
8
EG010
PF-06826647 400 mg QD MAD
During the MAD period (Period 2), the healthy participants who had taken PF-06826647 400 mg SD received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
0
6
0
6
1
6
EG011
PF-06826647 1600 mg SAD
During the SAD period (Period 1), the healthy participants received PF-06826647 1600 mg SD in fasted state. SAD period duration was 8 days. (These participants later continued into PF-06826647 1200 mg QD in MAD period.)
0
6
0
6
2
6
EG012
PF-06826647 1200 mg QD MAD
During the MAD period (Period 2), the healthy participants who had taken PF-06826647 1600 mg SD received PF-06826647 1200 mg QD for 10 days with standard meal. MAD period duration was 28 days.
0
5
0
5
1
5
EG013
PF-06826647 200 mg BID
During the MAD period (Period 2), the healthy participants received PF-06826647 200 mg BID for 10 days with standard meal. MAD period duration was 28 days.
0
7
0
7
3
7
EG014
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), the Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
0
5
0
5
1
5
EG015
Placebo QD PSO
In the psoriasis (PSO) cohorts, the psoriasis participants received placebo matching PF-06826647 400, or 100 mg QD PSO cohort for 28 days with standard meal. Psoriasis cohort duration was 84 days.
0
14
0
14
7
14
EG016
PF-06826647 400 mg QD PSO
In this psoriasis cohort, the psoriasis participants received PF-06826647 400 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
0
15
0
15
12
15
EG017
PF-06826647 100 mg QD PSO
In this psoriasis cohort, the psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
0
11
0
11
5
11
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cerumen impaction
Ear and labyrinth disorders
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected7 at risk
EG0080 events0 affected6 at risk
EG0090 events0 affected8 at risk
EG0100 events0 affected6 at risk
EG0110 events0 affected6 at risk
EG0120 events0 affected5 at risk
EG0130 events0 affected7 at risk
EG0140 events0 affected5 at risk
EG0150 events0 affected14 at risk
EG0161 events1 affected15 at risk
EG0170 events0 affected11 at risk
Ear discomfort
Ear and labyrinth disorders
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Epigastric discomfort
Gastrointestinal disorders
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Faeces hard
Gastrointestinal disorders
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Face oedema
General disorders
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Oedema
General disorders
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Peripheral swelling
General disorders
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Secretion discharge
General disorders
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Otitis externa
Infections and infestations
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Periorbital haematoma
Injury, poisoning and procedural complications
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Periorbital haemorrhage
Injury, poisoning and procedural complications
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Blood creatine phosphokinase
Investigations
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Blood creatinine increased
Investigations
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Blood uric acid increased
Investigations
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Body temperature
Investigations
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Headache
Nervous system disorders
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0011 events1 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v21.1
Non-systematic Assessment
EG0001 events1 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA v21.1
Non-systematic Assessment
EG0000 events0 affected13 at risk
EG0010 events0 affected9 at risk
EG0020 events0 affected2 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Supine diastolic BP Change (Chg) ≥20 mmHg increase
Title
Measurements
OG0003
OG0011
OG0021
OG0032
OG0041
OG0050
OG0062
Supine diastolic BP Chg ≥20 mmHg decrease
Title
Measurements
OG0002
OG0011
OG0022
OG0031
OG0042
OG0051
OG0060
Supine pulse rate Value <40 beats per minute (bpm)
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
Supine pulse rate Value >120 bpm
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
Supine systolic BP Value <90mmHg
Title
Measurements
OG0001
OG0011
OG0022
OG0031
OG0040
OG0050
OG0060
Supine systolic BP Chg ≥30 mmHg increase
Title
Measurements
OG0002
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
Supine systolic BP Chg ≥30mmHg decrease
Title
Measurements
OG0002
OG0011
OG0021
OG0030
OG0041
OG0050
OG0060
PF-06826647 30 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal.
OG003
PF-06826647 100 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 100 mg QD for 10 days with standard meal.
OG004
PF-06826647 400 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 400 mg QD for 10 days with standard meal.
OG005
PF-06826647 1200 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal.
OG006
PF-06826647 200 mg BID
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal. MAD period duration was 28 days.
OG007
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
Units
Counts
Participants
OG0009
OG0012
OG0026
OG0036
OG0046
OG0055
OG0067
OG0075
Title
Denominators
Categories
Supine diastolic BP Value < 50 mmHg
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0041
OG0050
OG0061
OG0071
Supine diastolic BP Chg ≥ 20 mmHg increase
Title
Measurements
OG0001
OG0010
OG0021
OG003
Supine diastolic BP Chg ≥ 20 mmHg decrease
Title
Measurements
OG0004
OG0010
OG0022
OG003
Supine pulse rate Value < 40 bpm
Title
Measurements
OG0000
OG0010
OG0020
OG003
Supine pulse rate Value > 120 bpm
Title
Measurements
OG0000
OG0010
OG0020
OG003
Supine systolic blood pressure Value < 90 mmHg
Title
Measurements
OG0001
OG0010
OG0020
OG003
Supine systolic BP Chg ≥ 30 mmHg increase
Title
Measurements
OG0001
OG0010
OG0021
OG003
Supine systolic BP Chg ≥ 30 mmHg decrease
Title
Measurements
OG0000
OG0010
OG0021
OG003
Units
Counts
Participants
OG00014
OG00115
OG00211
Title
Denominators
Categories
Supine diastolic blood pressure Value < 50 mmHg
Title
Measurements
OG0000
OG0011
OG0021
Supine diastolic BP Chg ≥ 20 mmHg increase
Title
Measurements
OG0000
OG0013
OG0025
Supine diastolic BP Chg ≥ 20 mmHg decrease
Title
Measurements
OG0006
OG0017
OG0024
Supine pulse rate Value < 40 bpm
Title
Measurements
OG0000
OG0010
OG0020
Supine pulse rate Value > 120 bpm
Title
Measurements
OG0000
OG0010
OG0020
Supine systolic BP Value < 90 mmHg
Title
Measurements
OG0001
OG0010
OG0020
Supine systolic BP Chg ≥ 30 mmHg increase
Title
Measurements
OG0000
OG0011
OG0022
Supine systolic BP Chg ≥ 30 mmHg decrease
Title
Measurements
OG0006
OG0015
OG0021
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
OG002
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
OG003
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
OG004
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
OG005
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
OG006
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
Units
Counts
Participants
OG00013
OG0016
OG0026
OG0038
OG0047
OG0058
OG0066
Title
Denominators
Categories
cardiovascular
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
ears
Title
Measurements
OG0000
OG0010
OG0020
OG003
eyes
Title
Measurements
OG0000
OG0010
OG0020
OG003
gastrointestinal
Title
Measurements
OG0000
OG0010
OG0020
OG003
general appearance
Title
Measurements
OG0000
OG0010
OG0020
OG003
head
Title
Measurements
OG0000
OG0010
OG0020
OG003
heart
Title
Measurements
OG0000
OG0010
OG0020
OG003
lungs
Title
Measurements
OG0000
OG0010
OG0020
OG003
lymph nodes
Title
Measurements
OG0000
OG0010
OG0020
OG003
mouth
Title
Measurements
OG0000
OG0010
OG0020
OG003
musculoskeletal
Title
Measurements
OG0000
OG0010
OG0020
OG003
neurological
Title
Measurements
OG0000
OG0010
OG0020
OG003
nose
Title
Measurements
OG0000
OG0010
OG0020
OG003
skin
Title
Measurements
OG0000
OG0010
OG0020
OG003
During the MAD period (Period 2), healthy participants received placebo matching PF-06826647 200 mg BID cohort with standard meal.
OG002
PF-06826647 30 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal.
OG003
PF-06826647 100 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 100 mg QD for 10 days with standard meal.
OG004
PF-06826647 400 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 400 mg QD for 10 days with standard meal.
OG005
PF-06826647 1200 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal.
OG006
PF-06826647 200 mg BID
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal. MAD period duration was 28 days.
OG007
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
Units
Counts
Participants
OG0009
OG0012
OG0026
OG0036
OG0046
OG0055
OG0067
OG0075
Title
Denominators
Categories
cardiovascular
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
ears
Title
Measurements
OG0000
OG0010
OG0020
OG003
eyes
Title
Measurements
OG0000
OG0010
OG0020
OG003
gastrointestinal
Title
Measurements
OG0000
OG0010
OG0020
OG003
general appearance
Title
Measurements
OG0000
OG0010
OG0020
OG003
head
Title
Measurements
OG0000
OG0010
OG0020
OG003
heart
Title
Measurements
OG0000
OG0010
OG0020
OG003
lungs
Title
Measurements
OG0000
OG0010
OG0020
OG003
lymph nodes
Title
Measurements
OG0000
OG0010
OG0020
OG003
mouth
Title
Measurements
OG0000
OG0010
OG0020
OG003
musculoskeletal
Title
Measurements
OG0000
OG0010
OG0020
OG003
neurological
Title
Measurements
OG0000
OG0010
OG0020
OG003
nose
Title
Measurements
OG0000
OG0010
OG0020
OG003
skin
Title
Measurements
OG0000
OG0010
OG0020
OG003
PF-06826647 100 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
Units
Counts
Participants
OG00014
OG00115
OG00211
Title
Denominators
Categories
cardiovascular
Title
Measurements
OG0000
OG0010
OG0020
ears at screening
Title
Measurements
OG0000
OG0010
OG0020
ears at Day 28
Title
Measurements
OG0000
OG0011
OG0020
eyes
Title
Measurements
OG0000
OG0010
OG0020
gastrointestinal
Title
Measurements
OG0000
OG0010
OG0020
general appearance
Title
Measurements
OG0000
OG0010
OG0020
head
Title
Measurements
OG0000
OG0010
OG0020
heart
Title
Measurements
OG0000
OG0010
OG0020
lungs
Title
Measurements
OG0000
OG0010
OG0020
lymph nodes
Title
Measurements
OG0000
OG0010
OG0020
mouth
Title
Measurements
OG0000
OG0010
OG0020
musculoskeletal
Title
Measurements
OG0000
OG0010
OG0020
neurological
Title
Measurements
OG0000
OG0010
OG0020
nose
Title
Measurements
OG0000
OG0010
OG0020
skin
Title
Measurements
OG0000
OG0010
OG0020
PF-06826647 3 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
OG002
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
OG003
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
OG004
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
OG005
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
OG006
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
Units
Counts
Participants
OG00013
OG0016
OG0026
OG0038
OG0047
OG0058
OG0066
Title
Denominators
Categories
PR maximum absolute value ≥300 msec
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
PR maximum increase from baseline ≥25/50%
Title
Measurements
OG0000
OG0010
OG0020
OG003
QRS maximum absolute value ≥140 msec
Title
Measurements
OG0000
OG0010
OG0020
OG003
QRS maximum increase from baseline ≥50%
Title
Measurements
OG0000
OG0010
OG0020
OG003
QTCF maximum absolute value ≥450 and <480 msec
Title
Measurements
OG0000
OG0010
OG0020
OG003
QTCF maximum absolute value ≥480 and <500 msec
Title
Measurements
OG0000
OG0010
OG0020
OG003
QTCF maximum absolute value ≥500 msec
Title
Measurements
OG0000
OG0010
OG0020
OG003
QTCF maximum increase ≥30 and <60 msec
Title
Measurements
OG0000
OG0011
OG0020
OG003
QTCF maximum increase from baseline ≥60 msec
Title
Measurements
OG0000
OG0010
OG0020
OG003
PBO BID
During the MAD period (Period 2), healthy participants received placebo matching PF-06826647 200 mg BID cohort with standard meal.
OG002
PF-06826647 30 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal.
OG003
PF-06826647 100 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 100 mg QD for 10 days with standard meal.
OG004
PF-06826647 400 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 400 mg QD for 10 days with standard meal.
OG005
PF-06826647 1200 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal.
OG006
PF-06826647 200 mg BID
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal. MAD period duration was 28 days.
OG007
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
Units
Counts
Participants
OG0009
OG0012
OG0026
OG0036
OG0046
OG0055
OG0067
OG0075
Title
Denominators
Categories
PR maximum absolute value ≥300 msec
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
PR maximum increase from baseline ≥25/50%
Title
Measurements
OG0000
OG0010
OG0020
OG003
QRS maximum absolute value ≥140 msec
Title
Measurements
OG0000
OG0010
OG0020
OG003
QRS maximum increase from baseline ≥50%
Title
Measurements
OG0000
OG0010
OG0020
OG003
QTCF maximum absolute value ≥450 and <480 msec
Title
Measurements
OG0000
OG0010
OG0020
OG003
QTCF maximum absolute value ≥480 and <500 msec
Title
Measurements
OG0000
OG0010
OG0020
OG003
QTCF maximum absolute value ≥500 msec
Title
Measurements
OG0000
OG0010
OG0020
OG003
QTCF maximum increase ≥30 and <60 msec
Title
Measurements
OG0000
OG0010
OG0020
OG003
QTCF maximum increase from baseline ≥60 msec
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
PF-06826647 100 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
Units
Counts
Participants
OG00014
OG00115
OG00211
Title
Denominators
Categories
PR maximum absolute value ≥300 msec
Title
Measurements
OG0000
OG0010
OG0020
PR maximum increase from baseline ≥25/50%
Title
Measurements
OG0000
OG0010
OG0020
QRS maximum absolute value ≥140 msec
Title
Measurements
OG0000
OG0010
OG0020
QRS maximum increase from baseline ≥50%
Title
Measurements
OG0000
OG0010
OG0020
QTCF maximum absolute value ≥450 and <480 msec
Title
Measurements
OG0000
OG0010
OG0020
QTCF maximum absolute value ≥480 and <500 msec
Title
Measurements
OG0000
OG0010
OG0020
QTCF maximum absolute value ≥500 msec
Title
Measurements
OG0000
OG0010
OG0020
QTCF maximum increase ≥30 and <60 msec
Title
Measurements
OG0000
OG0010
OG0020
QTCF maximum increase from baseline ≥60 msec
Title
Measurements
OG0000
OG0010
OG0020
OG001
PF-06826647 3 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 3 mg SD in fasted state.
OG002
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
OG003
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
OG004
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
OG005
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
OG006
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
Units
Counts
Participants
OG00013
OG0016
OG0026
OG0038
OG0047
OG0058
OG0066
Title
Denominators
Categories
Participants with AEs (AC)
Title
Measurements
OG0001
OG0010
OG0020
OG0030
OG0041
OG0050
OG0062
Participants with AEs (TR)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants with SAEs (AC)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants with SAEs (TR)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants with severe AEs (AC)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants with severe AEs (TR)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants withdrew due to AEs (AC)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants withdrew due to AEs (TR)
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG001
PBO BID
During the MAD period (Period 2), healthy participants received placebo matching PF-06826647 200 mg BID cohort with standard meal.
OG002
PF-06826647 30 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal.
OG003
PF-06826647 100 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 100 mg QD for 10 days with standard meal.
OG004
PF-06826647 400 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 400 mg QD for 10 days with standard meal.
OG005
PF-06826647 1200 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal.
OG006
PF-06826647 200 mg BID
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal. MAD period duration was 28 days.
OG007
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
Units
Counts
Participants
OG0009
OG0012
OG0026
OG0036
OG0046
OG0055
OG0067
OG0075
Title
Denominators
Categories
Participants with AEs (AC)
Title
Measurements
OG0002
OG0010
OG0022
OG0031
OG0041
OG0051
OG0063
OG0071
Participants with AEs (TR)
Title
Measurements
OG0001
OG0010
OG0021
OG003
Participants with SAEs (AC)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants with SAEs (TR)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants with severe AEs (AC)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants with severe AEs (TR)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants withdrew due to AEs (AC)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Participants withdrew due to AEs (TR)
Title
Measurements
OG0000
OG0010
OG0020
OG003
In this psoriasis cohort, psoriasis participants received PF-06826647 400 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
OG002
PF-06826647 100 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
Units
Counts
Participants
OG00014
OG00115
OG00211
Title
Denominators
Categories
Participants with AEs (AC)
Title
Measurements
OG0007
OG00112
OG0025
Participants with AEs (TR)
Title
Measurements
OG0005
OG0015
OG0023
Participants with SAEs (AC)
Title
Measurements
OG0000
OG0010
OG0020
Participants with SAEs (TR)
Title
Measurements
OG0000
OG0010
OG0020
Participants with severe AEs (AC)
Title
Measurements
OG0000
OG0010
OG0020
Participants with severe AEs (TR)
Title
Measurements
OG0000
OG0010
OG0020
Participants withdrew due to AEs (AC)
Title
Measurements
OG0000
OG0011
OG0020
Participants withdrew due to AEs (TR)
Title
Measurements
OG0000
OG0011
OG0020
OG002
PF-06826647 10 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 10 mg SD in fasted state.
OG003
PF-06826647 30 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 30 mg SD in fasted state.
OG004
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
OG005
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
OG006
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
Units
Counts
Participants
OG00013
OG0016
OG0026
OG0038
OG0047
OG0058
OG0066
Title
Denominators
Categories
Ery. MCV (femtoliters [fL]) <0.9 × LLN
ParticipantsOG00013
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0038
ParticipantsOG0047
ParticipantsOG0058
ParticipantsOG0066
Title
Measurements
OG0000
OG0010
OG0020
OG003
Ery. MCH (picograms [pg]) <0.9 × LLN
ParticipantsOG00013
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0038
Reticulocytes/erythrocytes (%) >1.5 x ULN
ParticipantsOG00013
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0038
Limphocytes (10^3/mm^3) <0.8 × LLN
ParticipantsOG00013
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0038
Eosinophils (10^3/mm^3) >1.2 x ULN
ParticipantsOG00013
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0038
Bilirubin (mg/dL) >1.5 x ULN
ParticipantsOG00013
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0038
AST (U/L) >3 x ULN
ParticipantsOG00013
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0038
Urate (mg/dL) >1.2 x ULN
ParticipantsOG00013
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0038
HDL cholesterol (mg/dL) <0.8 × LLN
ParticipantsOG00013
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0038
LDL cholesterol (mg/dL) >1.2 x ULN
ParticipantsOG00013
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0038
Triglycerides (mg/dL) >1.3 x ULN
ParticipantsOG00013
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0038
Cholesterol (mg/dL) >1.3 x ULN
ParticipantsOG00013
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0038
Ketones ≥1
ParticipantsOG00013
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0038
Nitrite ≥1
ParticipantsOG00013
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0038
Leukocyte esterase ≥1
ParticipantsOG00013
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG0038
Epithelial cells (/LPF) ≥6
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0030
Urinalysis-bacteria (/HPF) ≥20
ParticipantsOG0002
ParticipantsOG0011
ParticipantsOG0021
ParticipantsOG0030
OG001
PBO BID
During the MAD period (Period 2), healthy participants received placebo matching PF-06826647 200 mg BID cohort with standard meal.
OG002
PF-06826647 30 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 30 mg QD for 10 days with standard meal.
OG003
PF-06826647 100 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 100 mg QD for 10 days with standard meal.
OG004
PF-06826647 400 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 400 mg QD for 10 days with standard meal.
OG005
PF-06826647 1200 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal.
OG006
PF-06826647 200 mg BID
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal. MAD period duration was 28 days.
OG007
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
Units
Counts
Participants
OG0009
OG0012
OG0026
OG0036
OG0046
OG0055
OG0067
OG0075
Title
Denominators
Categories
Ery. MCV (fL) <0.9 × LLN
ParticipantsOG0009
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0036
ParticipantsOG0046
ParticipantsOG0055
ParticipantsOG0067
ParticipantsOG0075
Title
Measurements
OG0000
OG0010
OG0020
OG003
Ery. MCH (pg) <0.9 × LLN
ParticipantsOG0009
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0036
Ery. MCH (pg) >1.1 × ULN
ParticipantsOG0009
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0036
Reticulocytes/erythrocytes (%) >1.5 × ULN
ParticipantsOG0009
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0036
Lymphocytes (10^3/mm^3) <0.8 × LLN
ParticipantsOG0009
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0036
Lymphocytes (10^3/mm^3) >1.2 × ULN
ParticipantsOG0009
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0036
Neutrophils (10^3/mm^3) <0.8 × LLN
ParticipantsOG0009
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0036
Eosinophils (10^3/mm^3) >1.2 x ULN
ParticipantsOG0009
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0036
Bilirubin (mg/dL) >1.5 x ULN
ParticipantsOG0009
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0036
Urate (mg/dL) >1.2 x ULN
ParticipantsOG0009
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0036
HDL cholesterol (mg/dL) <0.8 × LLN
ParticipantsOG0009
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0036
LDL cholesterol (mg/dL) >1.2 x ULN
ParticipantsOG0009
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0036
Triglycerides (mg/dL) >1.3 x ULN
ParticipantsOG0009
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0036
Bicarbonate (mEq/L) >1.1 x ULN
ParticipantsOG0009
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0036
cholesterol (mg/dL) >1.3 x ULN
ParticipantsOG0009
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0036
Urine glucose ≥1
ParticipantsOG0009
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0036
Urine hemoglobin ≥1
ParticipantsOG0009
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0036
Nitrite ≥1
ParticipantsOG0009
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0036
Leukocyte esterase ≥1
ParticipantsOG0009
ParticipantsOG0012
ParticipantsOG0026
ParticipantsOG0036
Epithelial cells (/LPF) ≥6
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Urinalysis-casts (/LPF) >1
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Urinalysis-bacteria (/HPF) >20
ParticipantsOG0002
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0031
Urine 24 hours creatinine (mg/24 hr) >1.1 x ULN
ParticipantsOG0009
ParticipantsOG0011
ParticipantsOG0025
ParticipantsOG0036
OG002
PF-06826647 100 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.
Units
Counts
Participants
OG00014
OG00115
OG00211
Title
Denominators
Categories
Reticulocytes/erythrocytes (%) >1.5 x ULN
ParticipantsOG00014
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
OG0002
OG0013
OG0021
Lymphocytes (10^3/mm^3) <0.8 x LLN
ParticipantsOG00014
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
OG000
Neutrophils (10^3/mm^3) <0.8 x LLN
ParticipantsOG00014
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
OG000
Neutrophils (10^3/mm^3) >1.2 x ULN
ParticipantsOG00014
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
OG000
Eosinophils (10^3/mm^3) >1.2 x ULN
ParticipantsOG00014
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
OG000
Bilirubin (mg/dL) >1.5 x ULN
ParticipantsOG00014
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
OG000
ALT (U/L) >3 x ULN
ParticipantsOG00014
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
OG000
Creatinine (mg/dL) >1.3 x ULN
ParticipantsOG00014
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
OG000
Urate (mg/dL) >1.2 x ULN
ParticipantsOG00014
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
OG000
HDL cholesterol (mg/dL) <0.8 x LLN
ParticipantsOG00014
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
OG000
LDL cholesterol (mg/dL) >1.2 x ULN
ParticipantsOG00014
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
OG000
Triglycerides (mg/dL) >1.3 x ULN
ParticipantsOG00014
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
OG000
Potassium (mEq/L) >1.1 x ULN
ParticipantsOG00014
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
OG000
Bicarbonate (mEq/L) >1.1 x ULN
ParticipantsOG00014
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
OG000
Glucose (mg/dL) <0.6 x LLN
ParticipantsOG00014
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
OG000
Glucose (mg/dL) >1.5 x ULN
ParticipantsOG00014
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
OG000
CK (U/L) >2 x ULN
ParticipantsOG00014
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
OG000
cholesterol (mg/dL) >1.3 x ULN
ParticipantsOG00014
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
OG000
Urine glucose ≥1
ParticipantsOG00014
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
OG000
Ketones ≥1
ParticipantsOG00014
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
OG000
Urine hemoglobin ≥1
ParticipantsOG00014
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
OG000
Urine bilirubin ≥1
ParticipantsOG00014
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
OG000
Leukocyte esterase ≥1
ParticipantsOG00014
ParticipantsOG00115
ParticipantsOG00211
Title
Measurements
OG000
Epithelial cells (/LPF) ≥6
ParticipantsOG0004
ParticipantsOG0011
ParticipantsOG0023
Title
Measurements
OG000
Urinalysis-bacteria (/HPF) >20
ParticipantsOG0004
ParticipantsOG0011
ParticipantsOG0023
Title
Measurements
OG000
OG003
PF-06826647 100 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 100 mg QD for 10 days with standard meal.
OG004
PF-06826647 400 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 400 mg QD for 10 days with standard meal.
OG005
PF-06826647 1200 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal.
OG006
PF-06826647 200 mg BID
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal. MAD period duration was 28 days.
OG007
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
Units
Counts
Participants
OG0009
OG0011
OG0025
OG0036
OG0046
OG0055
OG0066
OG0075
Title
Denominators
Categories
Title
Measurements
OG000-21.0± 98.76
OG001-32.0± NAOne (1) participant was analyzed, so standard deviation did not exist.
OG002-62.4± 45.10
OG0030.2± 65.64
OG004-52.5± 56.22
OG005-11.4± 58.76
OG006-64.7± 36.22
OG00740.2± 45.26
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
OG004
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
OG005
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
Units
Counts
Participants
OG0005
OG0016
OG0026
OG0033
OG0047
OG0054
Title
Denominators
Categories
Title
Measurements
OG00047.63± 59
OG001369.3± 67
OG002848.4± 40
OG0031582± 42
OG0043056± 65
OG00511790± 25
OG003
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
OG004
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
OG005
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
Units
Counts
Participants
OG0005
OG0016
OG0026
OG0033
OG0047
OG0054
Title
Denominators
Categories
Title
Measurements
OG00015.86± 59
OG00136.93± 67
OG00228.28± 41
OG00315.82± 42
OG0047.636± 65
OG0057.370± 25
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
OG004
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
OG005
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
Units
Counts
Participants
OG0006
OG0016
OG0028
OG0037
OG0048
OG0056
Title
Denominators
Categories
Title
Measurements
OG00043.10± 56
OG001347.8± 62
OG002543.2± 49
OG0031158± 55
OG0042519± 67
OG0059318± 34
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
OG004
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
OG005
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
Units
Counts
Participants
OG0006
OG0016
OG0028
OG0037
OG0048
OG0056
Title
Denominators
Categories
Title
Measurements
OG00040.25± 56
OG001354.8± 67
OG002638.5± 58
OG0031375± 53
OG0042767± 65
OG0059921± 32
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
OG004
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
OG005
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
Units
Counts
Participants
OG0006
OG0016
OG0028
OG0037
OG0048
OG0056
Title
Denominators
Categories
Title
Measurements
OG00013.40± 56
OG00135.48± 67
OG00221.28± 58
OG00313.75± 53
OG0046.919± 65
OG0056.200± 32
OG004
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
OG005
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
Units
Counts
Participants
OG0006
OG0016
OG0028
OG0037
OG0048
OG0056
Title
Denominators
Categories
Title
Measurements
OG0007.844± 38
OG00147.09± 35
OG00277.93± 34
OG003166.8± 55
OG004404.8± 62
OG0051218± 25
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
OG004
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
OG005
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
Units
Counts
Participants
OG0006
OG0016
OG0028
OG0037
OG0048
OG0056
Title
Denominators
Categories
Title
Measurements
OG0002.617± 38
OG0014.709± 35
OG0022.597± 34
OG0031.668± 55
OG0041.012± 62
OG0050.7618± 25
OG004
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
OG005
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
Units
Counts
Participants
OG0006
OG0016
OG0028
OG0037
OG0048
OG0056
Title
Denominators
Categories
Title
Measurements
OG0002.00(1.00 to 2.00)
OG0012.00(1.00 to 4.00)
OG0022.00(1.00 to 4.00)
OG0032.00(2.00 to 6.00)
OG0042.00(0.500 to 4.00)
OG0052.00(0.500 to 4.00)
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
OG004
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
OG005
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
Units
Counts
Participants
OG0005
OG0016
OG0026
OG0033
OG0047
OG0054
Title
Denominators
Categories
Title
Measurements
OG0003.620± 1.2956
OG0016.032± 1.9050
OG00219.69± 9.5144
OG00338.77± 35.966
OG00416.25± 9.3430
OG00522.21± 24.586
OG004
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
OG005
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
Units
Counts
Participants
OG0005
OG0016
OG0026
OG0033
OG0047
OG0054
Title
Denominators
Categories
Title
Measurements
OG0005.596± 26
OG0017.761± 30
OG00216.97± 43
OG00321.23± 81
OG00410.56± 36
OG0059.417± 33
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
OG004
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
OG005
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
Units
Counts
Participants
OG0005
OG0016
OG0026
OG0033
OG0047
OG0054
Title
Denominators
Categories
Title
Measurements
OG000312.1± 34
OG001226.1± 41
OG002902.9± 81
OG0032671± 134
OG0042732± 128
OG0052877± 146
OG003
PF-06826647 100 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 100 mg SD in fasted state.
OG004
PF-06826647 400 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 400 mg SD in fasted state.
OG005
PF-06826647 1600 mg SAD
During the SAD period (Period 1), healthy participants received PF-06826647 1600 mg SD in fasted state.
Units
Counts
Participants
OG0005
OG0016
OG0026
OG0033
OG0047
OG0054
Title
Denominators
Categories
Title
Measurements
OG00062.98± 59
OG00127.08± 67
OG00235.36± 41
OG00363.21± 42
OG004130.8± 65
OG005135.4± 26
OG003
PF-06826647 400 QD MAD
In the MAD period (Period 2), these healthy participants in Cohort 5 received PF-06826647 400 mg QD for 10 days with standard meal.
OG004
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
OG005
PF-06826647 1200 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal.
Units
Counts
Participants
OG0006
OG0016
OG0027
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG000662.8± 25
OG0011803± 23
OG0021646± 70
OG0034424± 67
OG0046038± 29
OG00517090± 20
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal.
OG003
PF-06826647 400 QD MAD
In the MAD period (Period 2), these healthy participants in Cohort 5 received PF-06826647 400 mg QD for 10 days with standard meal.
OG004
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
OG005
PF-06826647 1200 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal.
Units
Counts
Participants
OG0006
OG0016
OG0027
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG00022.10± 25
OG00118.03± 23
OG0028.229± 70
OG00311.07± 67
OG00415.10± 29
OG00514.23± 20
In the MAD period (Period 2), these healthy participants in Cohort 5 received PF-06826647 400 mg QD for 10 days with standard meal.
OG004
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
OG005
PF-06826647 1200 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal.
Units
Counts
Participants
OG0006
OG0016
OG0027
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG00083.53± 24
OG001267.2± 20
OG002289.8± 67
OG003585.9± 33
OG004695.5± 19
OG0052023± 10
PF-06826647 400 QD MAD
In the MAD period (Period 2), these healthy participants in Cohort 5 received PF-06826647 400 mg QD for 10 days with standard meal.
OG004
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
OG005
PF-06826647 1200 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal.
Units
Counts
Participants
OG0006
OG0016
OG0027
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG0002.787± 24
OG0012.672± 20
OG0021.450± 67
OG0031.468± 33
OG0041.741± 19
OG0051.686± 10
In the MAD period (Period 2), these healthy participants in Cohort 5 received PF-06826647 400 mg QD for 10 days with standard meal.
OG004
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
OG005
PF-06826647 1200 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal.
Units
Counts
Participants
OG0006
OG0016
OG0027
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG0003.00(2.00 to 6.00)
OG0014.00(1.00 to 4.00)
OG0024.00(2.00 to 6.00)
OG0033.00(2.00 to 6.00)
OG0044.00(2.00 to 4.00)
OG0052.00(2.00 to 4.00)
OG003
PF-06826647 400 QD MAD
In the MAD period (Period 2), these healthy participants in Cohort 5 received PF-06826647 400 mg QD for 10 days with standard meal.
OG004
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
OG005
PF-06826647 1200 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal.
Units
Counts
Participants
OG0005
OG0016
OG0026
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG000752.9± 32
OG0011952± 33
OG0022010± 49
OG0035420± 57
OG0047194± 20
OG00514890± 31
During the MAD period (Period 2), healthy participants received PF-06826647 200 mg BID for 10 days with standard meal.
OG003
PF-06826647 400 QD MAD
In the MAD period (Period 2), these healthy participants in Cohort 5 received PF-06826647 400 mg QD for 10 days with standard meal.
OG004
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
OG005
PF-06826647 1200 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal.
Units
Counts
Participants
OG0005
OG0016
OG0026
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG00025.06± 32
OG00119.52± 33
OG00210.04± 49
OG00313.56± 57
OG00418.00± 19
OG00512.41± 31
In the MAD period (Period 2), these healthy participants in Cohort 5 received PF-06826647 400 mg QD for 10 days with standard meal.
OG004
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
OG005
PF-06826647 1200 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal.
Units
Counts
Participants
OG0005
OG0016
OG0026
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG00085.34± 27
OG001263.2± 30
OG002339.5± 46
OG003667.3± 37
OG004887.0± 11
OG0051855± 21
PF-06826647 400 QD MAD
In the MAD period (Period 2), these healthy participants in Cohort 5 received PF-06826647 400 mg QD for 10 days with standard meal.
OG004
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
OG005
PF-06826647 1200 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal.
Units
Counts
Participants
OG0005
OG0016
OG0026
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG0002.844± 27
OG0012.632± 30
OG0021.701± 46
OG0031.669± 37
OG0042.220± 11
OG0051.547± 21
In the MAD period (Period 2), these healthy participants in Cohort 5 received PF-06826647 400 mg QD for 10 days with standard meal.
OG004
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
OG005
PF-06826647 1200 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal.
Units
Counts
Participants
OG0005
OG0016
OG0026
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG0004.00(4.00 to 6.00)
OG0014.00(2.00 to 4.00)
OG0024.00(2.00 to 4.00)
OG0034.00(2.00 to 6.00)
OG0044.00(2.00 to 6.00)
OG0054.00(2.00 to 4.00)
OG003
PF-06826647 400 QD MAD
In the MAD period (Period 2), these healthy participants in Cohort 5 received PF-06826647 400 mg QD for 10 days with standard meal.
OG004
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
OG005
PF-06826647 1200 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal.
Units
Counts
Participants
OG0005
OG0016
OG0026
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG00031.36± 32
OG00181.28± 34
OG002167.6± 49
OG003226.0± 57
OG004299.7± 20
OG005619.9± 31
OG003
PF-06826647 400 QD MAD
In the MAD period (Period 2), these healthy participants in Cohort 5 received PF-06826647 400 mg QD for 10 days with standard meal.
OG004
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
OG005
PF-06826647 1200 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal.
Units
Counts
Participants
OG0005
OG0016
OG0026
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG0006.273± 83
OG00110.40± 75
OG00255.01± 65
OG00324.77± 148
OG00429.50± 60
OG00562.26± 112
OG003
PF-06826647 400 QD MAD
In the MAD period (Period 2), these healthy participants in Cohort 5 received PF-06826647 400 mg QD for 10 days with standard meal.
OG004
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
OG005
PF-06826647 1200 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal.
Units
Counts
Participants
OG0005
OG0015
OG0023
OG0034
OG0044
OG0055
Title
Denominators
Categories
Title
Measurements
OG0008.802± 5.8142
OG00112.72± 12.644
OG00226.93± 8.1132
OG0037.500± 2.5803
OG0047.433± 4.7975
OG00534.33± 21.926
In the MAD period (Period 2), these healthy participants in Cohort 5 received PF-06826647 400 mg QD for 10 days with standard meal.
OG004
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
OG005
PF-06826647 1200 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal.
Units
Counts
Participants
OG0005
OG0015
OG0023
OG0034
OG0044
OG0055
Title
Denominators
Categories
Title
Measurements
OG00010.56± 44
OG0019.872± 33
OG00217.14± 26
OG0039.622± 26
OG0047.996± 19
OG0059.165± 24
In the MAD period (Period 2), these healthy participants in Cohort 5 received PF-06826647 400 mg QD for 10 days with standard meal.
OG004
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
OG005
PF-06826647 1200 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal.
Units
Counts
Participants
OG0005
OG0016
OG0026
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG00013.61± 69
OG00125.31± 55
OG0026.951± 23
OG00326.92± 112
OG00430.09± 61
OG00529.76± 97
OG003
PF-06826647 400 QD MAD
In the MAD period (Period 2), these healthy participants in Cohort 5 received PF-06826647 400 mg QD for 10 days with standard meal.
OG004
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
OG005
PF-06826647 1200 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal.
Units
Counts
Participants
OG0005
OG0016
OG0026
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG0001.085± 8
OG0011.082± 21
OG0021.328± 52
OG0031.225± 39
OG0041.191± 24
OG0050.8711± 30
OG003
PF-06826647 400 QD MAD
In the MAD period (Period 2), these healthy participants in Cohort 5 received PF-06826647 400 mg QD for 10 days with standard meal.
OG004
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
OG005
PF-06826647 1200 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal.
Units
Counts
Participants
OG0005
OG0016
OG0026
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG0000.9295± 22
OG0010.9852± 24
OG0021.282± 57
OG0031.139± 35
OG0041.275± 14
OG0050.9176± 25
OG003
PF-06826647 400 QD MAD
In the MAD period (Period 2), these healthy participants in Cohort 5 received PF-06826647 400 mg QD for 10 days with standard meal.
OG004
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
OG005
PF-06826647 1200 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal.
Units
Counts
Participants
OG0005
OG0015
OG0023
OG0034
OG0044
OG0055
Title
Denominators
Categories
Title
Measurements
OG000433.5± 52
OG001643.6± 98
OG0023224± 90
OG003758.9± 93
OG004519.2± 67
OG0052944± 166
OG003
PF-06826647 400 QD MAD
In the MAD period (Period 2), these healthy participants in Cohort 5 received PF-06826647 400 mg QD for 10 days with standard meal.
OG004
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
OG005
PF-06826647 1200 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal.
Units
Counts
Participants
OG0005
OG0016
OG0026
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG00039.86± 32
OG00151.27± 34
OG00299.47± 49
OG00373.78± 57
OG00455.62± 20
OG00580.63± 31
OG003
PF-06826647 400 QD MAD
In the MAD period (Period 2), these healthy participants in Cohort 5 received PF-06826647 400 mg QD for 10 days with standard meal.
OG004
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
OG005
PF-06826647 1200 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal.
Units
Counts
Participants
OG0005
OG0016
OG0026
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG0000.2204± 35
OG0011.072± 65
OG0022.560± 66
OG0033.134± 75
OG0042.931± 624
OG00514.73± 92
OG003
PF-06826647 400 QD MAD
In the MAD period (Period 2), these healthy participants in Cohort 5 received PF-06826647 400 mg QD for 10 days with standard meal.
OG004
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
OG005
PF-06826647 1200 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal.
Units
Counts
Participants
OG0005
OG0016
OG0026
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG0000.7344± 35
OG0011.072± 65
OG0021.280± 66
OG0030.7827± 75
OG0040.7333± 624
OG0051.228± 92
OG003
PF-06826647 400 QD MAD
In the MAD period (Period 2), these healthy participants in Cohort 5 received PF-06826647 400 mg QD for 10 days with standard meal.
OG004
PF-06826647 400 mg QD MAD JP
During the MAD period (Period 2), Japanese healthy participants received PF-06826647 400 mg QD for 10 days with standard meal. MAD period duration was 28 days.
OG005
PF-06826647 1200 mg QD MAD
In the MAD period (Period 2), these healthy participants received PF-06826647 1200 mg QD for 10 days with standard meal.
Units
Counts
Participants
OG0005
OG0016
OG0026
OG0036
OG0045
OG0055
Title
Denominators
Categories
Title
Measurements
OG0000.2928± 70
OG0010.5500± 42
OG0021.274± 39
OG0030.5777± 34
OG0040.4076± 500
OG0050.9909± 58
OG000
10
OG00113
Title
Denominators
Categories
Title
Measurements
OG0002401± 53
OG0017664± 34
OG00010
OG00113
Title
Denominators
Categories
Title
Measurements
OG00024.01± 53
OG00119.17± 34
OG000
10
OG00113
Title
Denominators
Categories
Title
Measurements
OG000296.6± 38
OG001869.8± 25
OG000
10
OG00113
Title
Denominators
Categories
Title
Measurements
OG0002.966± 38
OG0012.176± 25
OG000
10
OG00113
Title
Denominators
Categories
Title
Measurements
OG0004.00(1.00 to 6.00)
OG0014.00(2.00 to 6.00)
OG000
10
OG00113
Title
Denominators
Categories
Title
Measurements
OG000100.2± 53
OG001319.3± 34
OG000
10
OG00113
Title
Denominators
Categories
Title
Measurements
OG00021.92± 103
OG00138.12± 176
Participants
OG00010
OG00111
Title
Denominators
Categories
Title
Measurements
OG0007.796± 5.7087
OG0016.809± 5.4050
OG00010
OG00111
Title
Denominators
Categories
Title
Measurements
OG00011.27± 41
OG0019.444± 28
10
OG00113
Title
Denominators
Categories
Title
Measurements
OG00013.52± 76
OG00122.81± 171
OG00010
OG00111
Title
Denominators
Categories
Title
Measurements
OG000408.1± 30
OG001461.2± 54
Units
Counts
Participants
OG00010
OG00113
Title
Denominators
Categories
Title
Measurements
OG00041.61± 53
OG00152.21± 34
PF-06826647 100 mg QD PSO
In this psoriasis cohort, psoriasis participants received PF-06826647 100 mg QD for 28 days with standard meal. Psoriasis cohort duration was 84 days.