Plaque Psoriasis
Conditions
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.
Interventions
DRUGPF-06826647 tablet
PF-06826647 tablet for oral administration
DRUGPF-06826647 oral suspension
PF-06826647 suspension for oral administration (oral suspension to be administered to the 3mg starting dose cohort only)
OTHERPlacebo oral solution/suspension
placebo oral solution for the single ascending dose, first cohort only
OTHERPlacebo tablet
Matching placebo tablet
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blind treatment
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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) * Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Baseline up to Day 8 | 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. |
| Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Baseline up to Day 28 | 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. |
| Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | Baseline up to Day 56 | 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. |
| Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | Baseline up to Day 8 | 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. |
| Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | Baseline up to Day 28 | 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 With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | Baseline up to Day 56 | 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 With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | Baseline up to Day 8 | 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. |
| Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | Baseline up to Day 28 | 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 With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | Baseline up to Day 56 | 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 With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Baseline up to Day 8 | 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. |
| Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Baseline up to Day 28 | 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. |
| Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts) | Baseline up to Day 84 | 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. |
| Number of Participants With Laboratory Abnormalities (SAD Period) | Baseline up to Day 8 | 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. |
| Number of Participants With Laboratory Abnormalities (MAD Period) | Baseline up to Day 28 | 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. |
| Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Baseline up to Day 56 | 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: reticulocytes/erythrocytes (%) \>1.5 × ULN, lymphocytes \<0.8 × LLN, neutrophils \<0.8 × LLN or \>1.2 × ULN, eosinophils \>1.2 × ULN, bilirubin \>1.5 × ULN, alanine aminotransferase (ALT) \>3.0 × ULN, creatinine \>1.3 × ULN, urate \>1.2 × ULN, HDL cholesterol \<0.8 × LLN, LDL cholesterol \>1.2 × ULN, triglycerides \>1.3 × ULN, potassium \>1.1 × ULN, bicarbonate \>1.1 × ULN, glucose \<0.6 × LLN or \>1.5 × ULN, Creatine Kinase (CK) \>2.0 × ULN, cholesterol \>1.3 × ULN, urine glucose ≥1, ketones ≥1, urine hemoglobin ≥1, urine bilirubin ≥1, leukocyte esterase ≥1, epithelial cells ≥6/LPF, urinalysis-bacteria/HPF. |
| Change in 24 Hour Creatinine Clearance From Day -1 on Day 10 (MAD Period) | Day -1 and Day 10 | Change in 24-hour creatinine clearance at Day 10 from Day -1 (baseline) during the MAD was presented by treatment group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tmax (MAD Period Day 1) | Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose | Tmax was summarized by dosing regimen and period. It was observed directly from data as time of first occurrence. |
| AUCτ (MAD Period Day 10) | Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose | AUCτ was summarized by dosing regimen and period. Dosing interval was the interval τ 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. |
| AUCτ(dn) (MAD Period Day 10) | Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose | Area Under the Plasma Concentration-Time Profile over the Dosing interval τ (AUCτ). 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. AUCτ(dn) = AUCτ / Dose. To assess the relationship between the PK parameters and the dose, dose normalized AUCτ was plotted against dose, and included individual participant values and the geometric means for each dose. |
| Cmax (MAD Period Day 10) | Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose | Cmax was summarized by dosing regimen and period. It was observed directly from data. |
| Cmax(dn) (MAD Period Day 10) | Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose | 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. |
| Tmax (MAD Period Day 10) | Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose | Tmax was summarized by dosing regimen and period. It was observed directly from data as time of first occurrence. |
| Average Concentration at Steady State (Cav) (MAD Period Day 10) | Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose | Cav = AUCτ,ss / τ, where ss means 'at steady state', and where the dosing interval τ was 24 hours for QD dosing and 12 hours for BID dosing. Cav was summarized by dosing regimen and period. |
| Lowest Concentration Observed During the Dosing Interval τ (Cmin) (MAD Period Day 10) | Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose | Cmin was observed directly from data. It was summarized by dosing regimen and period. 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. |
| Terminal Elimination Half-Life ((t½) (MAD Period Day 10) | Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24,48,72,96,168 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. |
| MRT (MAD Period Day 10) | Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24,48,72,96,168 hours post-dose | MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from time 0 to infinity. |
| Peak Trough Ratio (PTR) (MAD Period Day 10) | Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose | PTR = Cmax,ss / Cmin,ss, where ss means 'at steady state'. It was summarized by dosing regimen and period. |
| Observed Accumulation Ratio Based on AUC (Rac) (MAD Period Day 10) | Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose | Rac = AUCτ,ss / AUCτ,sd, where ss means 'at steady state' and sd 'single dose'. In this study, Rac = AUCτ(Day 10) / AUCτ(Day 1). Rac was summarized by dosing regimen and period. |
| Observed Accumulation Ratio Based on Cmax (Rac,Cmax) (MAD Period Day 10) | Days 1 and 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose | 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. |
| Vz/F (MAD Period Day 10) | Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose | 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. |
| CL/F (MAD Period Day 10) | Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose | 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. |
| Cumulative Amount of Drug Recovered Unchanged in Urine From Time 0 to the Dosing Interval τ Hours Post-Dose (Aeτ) (MAD Period Day 10) | Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose | 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. |
| Percentage of Dose Recovered Unchanged in Urine From Time 0 to the Dosing Interval τ Hours Post-Dose (Aeτ%) (MAD Period Day 10) | Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose | 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. |
| Renal Clearance (Clr) (MAD Period Day 10) | Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose | 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. |
| AUCτ (Psoriasis Cohorts) | Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose | AUCτ was summarized by dosing regimen and period. It was determined by linear/log trapezoidal method. |
| AUCτ(dn) (Psoriasis Cohorts) | Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose | AUCτ(dn) = AUCτ / Dose. To assess the relationship between the PK parameters and the dose, dose normalized AUCτ was plotted against dose, and included individual participant values and the geometric means for each dose. |
| Cmax (Psoriasis Cohorts) | Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose | Cmax was summarized by dosing regimen and period. It was observed directly from data. |
| Cmax(dn) (Psoriasis Cohorts) | Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose | Cmax was summarized by dosing regimen and period. It was observed directly from data. |
| Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) (SAD Period) | Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose | 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). |
| Cav (Psoriasis Cohorts) | Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose | Cav = AUCτ,ss / τ, where ss means 'at steady state'. Cav was summarized by dosing regimen and period. |
| Cmin (Psoriasis Cohorts) | Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose | Cmin was observed directly from data. It was summarized by dosing regimen and period. |
| Terminal Elimination Half-Life ((t½) (Psoriasis Cohorts) | Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24,168 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. |
| MRT (Psoriasis Cohorts) | Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24,168 hours post-dose | MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from time 0 to infinity. |
| PTR (Psoriasis Cohorts) | Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose | PTR = Cmax,ss / Cmin,ss, it was summarized by dosing regimen and period. |
| Vz/F (Psoriasis Cohorts) | Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose | 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. |
| CL/F (Psoriasis Cohorts) | Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose | 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. |
| Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 28 | Baseline and 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. |
| Tmax (Psoriasis Cohorts) | Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose | Tmax was summarized by dosing regimen and period. It was observed directly from data as time of first occurrence. |
| Secondary: Dose Normalized AUCinf (AUCinf[dn]) (SAD Period) | Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose | 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. |
| Area Under the Concentration-Time Profile From Time 0 to 24 Hours (AUC24) (SAD Period) | Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose | AUC24 was summarized by dosing regimen and period. It was determined by linear/log trapezoidal method. |
| Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) (SAD Period) | Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose | AUClast was summarized by dosing regimen and period. It was determined by linear/log trapezoidal method. |
| Dose Normalized AUClast (AUClast[dn]) (SAD Period) | 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. |
| Maximum Plasma Concentration (Cmax) (SAD Period) | Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose | Cmax was summarized by dosing regimen and period. It was observed directly from data. |
| Area Under the Plasma Concentration-Time Profile Over the Dosing Interval τ (AUCτ) (MAD Period Day 1) | Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose | AUCτ was summarized by dosing regimen and period. Dosing interval was the interval τ 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. |
| Dose Normalized Cmax (Cmax[dn]) (SAD Period) | Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose | 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. |
| Time for Cmax (Tmax) (SAD Period) | Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose | Tmax was summarized by dosing regimen and period. It was observed directly from data as time of first occurrence. |
| Terminal Elimination Half-Life ((t½) (SAD Period) | 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. |
| Mean Residence Time (MRT) (SAD Period) | Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose | MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from time 0 to infinity. |
| Apparent Volume of Distribution (Vz/F) (SAD Period) | Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose | 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. |
| Apparent Clearance (CL/F) (SAD Period) | Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose | 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. |
| Dose Normalized AUCτ (AUCτ[dn]) (MAD Period Day 1) | Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose | Area Under the Plasma Concentration-Time Profile over the Dosing interval τ (AUCτ). 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. AUCτ(dn) = AUCτ / Dose. To assess the relationship between the PK parameters and the dose, dose normalized AUCτ was plotted against dose, and included individual participant values and the geometric means for each dose. |
| Cmax (MAD Period Day 1) | Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose | Cmax was summarized by dosing regimen and period. It was observed directly from data. |
| Cmax(dn) (MAD Period Day 1) | Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| 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. | 9 |
| 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. | 1 |
| PBO BID During the MAD period (Period 2), healthy participants received placebo matching PF-06826647 200 mg BID cohort with standard meal. | 2 |
| 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. | 6 |
| 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. | 6 |
| 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. | 8 |
| 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. | 7 |
| 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. | 8 |
| 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. | 6 |
| 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. | 7 |
| 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. | 5 |
| 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. | 14 |
| 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. | 15 |
| 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. | 11 |
| Total | 109 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | No Longer Meets Eligibility Criteria | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Other | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 2 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo (PBO) SAD (3 mg, 10 mg) | PBO SAD Followed by (->) PBO QD MAD | PBO QD MAD Japanese Cohort (JP) | PBO BID | PF-06826647 3 mg SAD | PF-06826647 10 mg SAD | PF-06826647 30 mg SAD -> 30 mg QD MAD | PF-06826647 100 mg SAD -> 100 mg QD MAD | PF-06826647 400 mg SAD -> 400 mg QD MAD | PF-06826647 1600 mg SAD -> 1200 mg QD MAD | PF-06826647 200 mg BID | PF-06826647 400 mg QD MAD JP | PBO QD Psoriasis Cohort (PSO) | PF-06826647 400 mg QD PSO | PF-06826647 100 mg QD PSO | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 38.5 years STANDARD_DEVIATION 12.23 | 42.2 years STANDARD_DEVIATION 10.84 | 34.0 years | 32.5 years STANDARD_DEVIATION 4.95 | 44.3 years STANDARD_DEVIATION 11.47 | 40.2 years STANDARD_DEVIATION 10.3 | 40.5 years STANDARD_DEVIATION 11.64 | 36.9 years STANDARD_DEVIATION 7.4 | 37.5 years STANDARD_DEVIATION 8.23 | 31.2 years STANDARD_DEVIATION 5 | 37.4 years STANDARD_DEVIATION 9.27 | 39.8 years STANDARD_DEVIATION 5.4 | 38.3 years STANDARD_DEVIATION 13.25 | 40.9 years STANDARD_DEVIATION 11.62 | 39.0 years STANDARD_DEVIATION 13.39 | 39.0 years STANDARD_DEVIATION 10.53 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 4 Participants | 4 Participants | 2 Participants | 0 Participants | 7 Participants | 4 Participants | 8 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 4 Participants | 1 Participants | 2 Participants | 6 Participants | 6 Participants | 5 Participants | 6 Participants | 4 Participants | 2 Participants | 5 Participants | 5 Participants | 7 Participants | 11 Participants | 3 Participants | 69 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 5 Participants | 1 Participants | 3 Participants | 0 Participants | 17 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 2 Participants | 4 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 6 Participants | 0 Participants | 1 Participants | 3 Participants | 1 Participants | 6 Participants | 3 Participants | 6 Participants | 5 Participants | 4 Participants | 0 Participants | 11 Participants | 9 Participants | 11 Participants | 69 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 1 Participants | 2 Participants | 6 Participants | 5 Participants | 8 Participants | 7 Participants | 7 Participants | 6 Participants | 7 Participants | 5 Participants | 14 Participants | 15 Participants | 11 Participants | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 9 | 0 / 2 | 0 / 6 | 0 / 6 | 0 / 8 | 0 / 6 | 0 / 7 | 0 / 6 | 0 / 8 | 0 / 6 | 0 / 6 | 0 / 5 | 0 / 7 | 0 / 5 | 0 / 14 | 0 / 15 | 0 / 11 |
| other Total, other adverse events | 1 / 13 | 2 / 9 | 0 / 2 | 0 / 6 | 0 / 6 | 0 / 8 | 2 / 6 | 1 / 7 | 1 / 6 | 0 / 8 | 1 / 6 | 2 / 6 | 1 / 5 | 3 / 7 | 1 / 5 | 7 / 14 | 12 / 15 | 5 / 11 |
| serious Total, serious adverse events | 0 / 13 | 0 / 9 | 0 / 2 | 0 / 6 | 0 / 6 | 0 / 8 | 0 / 6 | 0 / 7 | 0 / 6 | 0 / 8 | 0 / 6 | 0 / 6 | 0 / 5 | 0 / 7 | 0 / 5 | 0 / 14 | 0 / 15 | 0 / 11 |
Outcome results
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.
Time frame: Day -1 and Day 10
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Change in 24 Hour Creatinine Clearance From Day -1 on Day 10 (MAD Period) | -21.0 milliliters per minute (mL/min) | Standard Deviation 98.76 |
| PF-06826647 3 mg SAD | Change in 24 Hour Creatinine Clearance From Day -1 on Day 10 (MAD Period) | -32.0 milliliters per minute (mL/min) | — |
| PF-06826647 10 mg SAD | Change in 24 Hour Creatinine Clearance From Day -1 on Day 10 (MAD Period) | -62.4 milliliters per minute (mL/min) | Standard Deviation 45.1 |
| PF-06826647 30 mg SAD | Change in 24 Hour Creatinine Clearance From Day -1 on Day 10 (MAD Period) | 0.2 milliliters per minute (mL/min) | Standard Deviation 65.64 |
| PF-06826647 100 mg SAD | Change in 24 Hour Creatinine Clearance From Day -1 on Day 10 (MAD Period) | -52.5 milliliters per minute (mL/min) | Standard Deviation 56.22 |
| PF-06826647 400 mg SAD | Change in 24 Hour Creatinine Clearance From Day -1 on Day 10 (MAD Period) | -11.4 milliliters per minute (mL/min) | Standard Deviation 58.76 |
| PF-06826647 1600 mg SAD | Change in 24 Hour Creatinine Clearance From Day -1 on Day 10 (MAD Period) | -64.7 milliliters per minute (mL/min) | Standard Deviation 36.22 |
| PF-06826647 400 mg QD MAD JP | Change in 24 Hour Creatinine Clearance From Day -1 on Day 10 (MAD Period) | 40.2 milliliters per minute (mL/min) | Standard Deviation 45.26 |
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%.
Time frame: Baseline up to Day 28
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PBO SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum increase ≥30 and <60 msec | 0 Participants |
| PBO SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QRS maximum increase from baseline ≥50% | 0 Participants |
| PBO SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum absolute value ≥500 msec | 0 Participants |
| PBO SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum absolute value ≥480 and <500 msec | 0 Participants |
| PBO SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum increase from baseline ≥60 msec | 0 Participants |
| PBO SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | PR maximum increase from baseline ≥25/50% | 0 Participants |
| PBO SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum absolute value ≥450 and <480 msec | 0 Participants |
| PBO SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QRS maximum absolute value ≥140 msec | 0 Participants |
| PBO SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | PR maximum absolute value ≥300 msec | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QRS maximum absolute value ≥140 msec | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | PR maximum absolute value ≥300 msec | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QRS maximum increase from baseline ≥50% | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum increase ≥30 and <60 msec | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum absolute value ≥450 and <480 msec | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum increase from baseline ≥60 msec | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | PR maximum increase from baseline ≥25/50% | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum absolute value ≥480 and <500 msec | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum absolute value ≥500 msec | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QRS maximum absolute value ≥140 msec | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum absolute value ≥480 and <500 msec | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum increase from baseline ≥60 msec | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | PR maximum increase from baseline ≥25/50% | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | PR maximum absolute value ≥300 msec | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum increase ≥30 and <60 msec | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QRS maximum increase from baseline ≥50% | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum absolute value ≥500 msec | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum absolute value ≥450 and <480 msec | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QRS maximum increase from baseline ≥50% | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QRS maximum absolute value ≥140 msec | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum absolute value ≥450 and <480 msec | 1 Participants |
| PF-06826647 30 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum increase ≥30 and <60 msec | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | PR maximum increase from baseline ≥25/50% | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum increase from baseline ≥60 msec | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum absolute value ≥500 msec | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | PR maximum absolute value ≥300 msec | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum absolute value ≥480 and <500 msec | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum absolute value ≥450 and <480 msec | 1 Participants |
| PF-06826647 100 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | PR maximum absolute value ≥300 msec | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | PR maximum increase from baseline ≥25/50% | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QRS maximum absolute value ≥140 msec | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QRS maximum increase from baseline ≥50% | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum absolute value ≥480 and <500 msec | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum absolute value ≥500 msec | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum increase ≥30 and <60 msec | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum increase from baseline ≥60 msec | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | PR maximum increase from baseline ≥25/50% | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | PR maximum absolute value ≥300 msec | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum absolute value ≥500 msec | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QRS maximum absolute value ≥140 msec | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QRS maximum increase from baseline ≥50% | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum increase from baseline ≥60 msec | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum absolute value ≥450 and <480 msec | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum increase ≥30 and <60 msec | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum absolute value ≥480 and <500 msec | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum increase ≥30 and <60 msec | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | PR maximum absolute value ≥300 msec | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum absolute value ≥450 and <480 msec | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum absolute value ≥500 msec | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QRS maximum increase from baseline ≥50% | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QRS maximum absolute value ≥140 msec | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | PR maximum increase from baseline ≥25/50% | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum increase from baseline ≥60 msec | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum absolute value ≥480 and <500 msec | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum increase from baseline ≥60 msec | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum absolute value ≥480 and <500 msec | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QRS maximum increase from baseline ≥50% | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QRS maximum absolute value ≥140 msec | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum absolute value ≥500 msec | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | PR maximum increase from baseline ≥25/50% | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum increase ≥30 and <60 msec | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | PR maximum absolute value ≥300 msec | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period) | QTCF maximum absolute value ≥450 and <480 msec | 1 Participants |
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%.
Time frame: Baseline up to Day 56
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PBO SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | QRS maximum increase from baseline ≥50% | 0 Participants |
| PBO SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | QTCF maximum increase from baseline ≥60 msec | 0 Participants |
| PBO SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | QTCF maximum absolute value ≥480 and <500 msec | 0 Participants |
| PBO SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | QTCF maximum absolute value ≥450 and <480 msec | 0 Participants |
| PBO SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | PR maximum absolute value ≥300 msec | 0 Participants |
| PBO SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | QTCF maximum increase ≥30 and <60 msec | 0 Participants |
| PBO SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | QRS maximum absolute value ≥140 msec | 0 Participants |
| PBO SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | PR maximum increase from baseline ≥25/50% | 0 Participants |
| PBO SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | QTCF maximum absolute value ≥500 msec | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | QTCF maximum absolute value ≥450 and <480 msec | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | PR maximum absolute value ≥300 msec | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | PR maximum increase from baseline ≥25/50% | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | QRS maximum absolute value ≥140 msec | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | QRS maximum increase from baseline ≥50% | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | QTCF maximum absolute value ≥480 and <500 msec | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | QTCF maximum absolute value ≥500 msec | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | QTCF maximum increase ≥30 and <60 msec | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | QTCF maximum increase from baseline ≥60 msec | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | QRS maximum absolute value ≥140 msec | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | PR maximum absolute value ≥300 msec | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | QTCF maximum absolute value ≥500 msec | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | PR maximum increase from baseline ≥25/50% | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | QTCF maximum increase from baseline ≥60 msec | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | QTCF maximum absolute value ≥450 and <480 msec | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | QRS maximum increase from baseline ≥50% | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | QTCF maximum increase ≥30 and <60 msec | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | QTCF maximum absolute value ≥480 and <500 msec | 0 Participants |
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.
Time frame: Baseline up to Day 8
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PBO SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QRS maximum increase from baseline ≥50% | 0 Participants |
| PBO SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum absolute value ≥500 msec | 0 Participants |
| PBO SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QRS maximum absolute value ≥140 msec | 0 Participants |
| PBO SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum absolute value ≥450 and <480 msec | 0 Participants |
| PBO SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum increase ≥30 and <60 msec | 0 Participants |
| PBO SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum absolute value ≥480 and <500 msec | 0 Participants |
| PBO SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum increase from baseline ≥60 msec | 0 Participants |
| PBO SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | PR maximum increase from baseline ≥25/50% | 0 Participants |
| PBO SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | PR maximum absolute value ≥300 msec | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum absolute value ≥480 and <500 msec | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum absolute value ≥450 and <480 msec | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum increase from baseline ≥60 msec | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | PR maximum increase from baseline ≥25/50% | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum increase ≥30 and <60 msec | 1 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QRS maximum absolute value ≥140 msec | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | PR maximum absolute value ≥300 msec | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum absolute value ≥500 msec | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QRS maximum increase from baseline ≥50% | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum absolute value ≥500 msec | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum absolute value ≥450 and <480 msec | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | PR maximum absolute value ≥300 msec | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | PR maximum increase from baseline ≥25/50% | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum absolute value ≥480 and <500 msec | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum increase ≥30 and <60 msec | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QRS maximum increase from baseline ≥50% | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QRS maximum absolute value ≥140 msec | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum increase from baseline ≥60 msec | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum absolute value ≥480 and <500 msec | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | PR maximum absolute value ≥300 msec | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | PR maximum increase from baseline ≥25/50% | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QRS maximum absolute value ≥140 msec | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QRS maximum increase from baseline ≥50% | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum absolute value ≥450 and <480 msec | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum absolute value ≥500 msec | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum increase ≥30 and <60 msec | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum increase from baseline ≥60 msec | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum increase ≥30 and <60 msec | 1 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QRS maximum increase from baseline ≥50% | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | PR maximum absolute value ≥300 msec | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QRS maximum absolute value ≥140 msec | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum absolute value ≥450 and <480 msec | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum increase from baseline ≥60 msec | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum absolute value ≥500 msec | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum absolute value ≥480 and <500 msec | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | PR maximum increase from baseline ≥25/50% | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | PR maximum increase from baseline ≥25/50% | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QRS maximum increase from baseline ≥50% | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum increase ≥30 and <60 msec | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | PR maximum absolute value ≥300 msec | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum absolute value ≥500 msec | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QRS maximum absolute value ≥140 msec | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum absolute value ≥450 and <480 msec | 1 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum increase from baseline ≥60 msec | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum absolute value ≥480 and <500 msec | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | PR maximum increase from baseline ≥25/50% | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum absolute value ≥480 and <500 msec | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QRS maximum absolute value ≥140 msec | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum absolute value ≥500 msec | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QRS maximum increase from baseline ≥50% | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum increase ≥30 and <60 msec | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | PR maximum absolute value ≥300 msec | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum increase from baseline ≥60 msec | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period) | QTCF maximum absolute value ≥450 and <480 msec | 0 Participants |
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.
Time frame: Baseline up to Day 28
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PBO SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urine 24 hours creatinine (mg/24 hr) >1.1 x ULN | 3 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Reticulocytes/erythrocytes (%) >1.5 × ULN | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urine hemoglobin ≥1 | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Neutrophils (10^3/mm^3) <0.8 × LLN | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Bicarbonate (mEq/L) >1.1 x ULN | 1 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Triglycerides (mg/dL) >1.3 x ULN | 1 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Epithelial cells (/LPF) ≥6 | 1 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Eosinophils (10^3/mm^3) >1.2 x ULN | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urinalysis-casts (/LPF) >1 | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Lymphocytes (10^3/mm^3) <0.8 × LLN | 2 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | HDL cholesterol (mg/dL) <0.8 × LLN | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Lymphocytes (10^3/mm^3) >1.2 × ULN | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urate (mg/dL) >1.2 x ULN | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | cholesterol (mg/dL) >1.3 x ULN | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Ery. MCH (pg) >1.1 × ULN | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Nitrite ≥1 | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urine glucose ≥1 | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urinalysis-bacteria (/HPF) >20 | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | LDL cholesterol (mg/dL) >1.2 x ULN | 7 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Ery. MCH (pg) <0.9 × LLN | 1 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Leukocyte esterase ≥1 | 1 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Ery. MCV (fL) <0.9 × LLN | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urine glucose ≥1 | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urine hemoglobin ≥1 | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urate (mg/dL) >1.2 x ULN | 1 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | HDL cholesterol (mg/dL) <0.8 × LLN | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Triglycerides (mg/dL) >1.3 x ULN | 1 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urinalysis-bacteria (/HPF) >20 | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Ery. MCH (pg) >1.1 × ULN | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | LDL cholesterol (mg/dL) >1.2 x ULN | 1 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Reticulocytes/erythrocytes (%) >1.5 × ULN | 1 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Ery. MCV (fL) <0.9 × LLN | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urinalysis-casts (/LPF) >1 | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Lymphocytes (10^3/mm^3) <0.8 × LLN | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | cholesterol (mg/dL) >1.3 x ULN | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Epithelial cells (/LPF) ≥6 | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Lymphocytes (10^3/mm^3) >1.2 × ULN | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Bicarbonate (mEq/L) >1.1 x ULN | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Neutrophils (10^3/mm^3) <0.8 × LLN | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urine 24 hours creatinine (mg/24 hr) >1.1 x ULN | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Leukocyte esterase ≥1 | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Eosinophils (10^3/mm^3) >1.2 x ULN | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Nitrite ≥1 | 1 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Ery. MCH (pg) <0.9 × LLN | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | cholesterol (mg/dL) >1.3 x ULN | 1 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Leukocyte esterase ≥1 | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Reticulocytes/erythrocytes (%) >1.5 × ULN | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Bilirubin (mg/dL) >1.5 x ULN | 1 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Neutrophils (10^3/mm^3) <0.8 × LLN | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Triglycerides (mg/dL) >1.3 x ULN | 1 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Ery. MCH (pg) >1.1 × ULN | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urate (mg/dL) >1.2 x ULN | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | LDL cholesterol (mg/dL) >1.2 x ULN | 4 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | HDL cholesterol (mg/dL) <0.8 × LLN | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urine glucose ≥1 | 1 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urine hemoglobin ≥1 | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Ery. MCV (fL) <0.9 × LLN | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Eosinophils (10^3/mm^3) >1.2 x ULN | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Bicarbonate (mEq/L) >1.1 x ULN | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Epithelial cells (/LPF) ≥6 | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urinalysis-bacteria (/HPF) >20 | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Lymphocytes (10^3/mm^3) <0.8 × LLN | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Ery. MCH (pg) <0.9 × LLN | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Lymphocytes (10^3/mm^3) >1.2 × ULN | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Nitrite ≥1 | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urine 24 hours creatinine (mg/24 hr) >1.1 x ULN | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urinalysis-casts (/LPF) >1 | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | LDL cholesterol (mg/dL) >1.2 x ULN | 2 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Triglycerides (mg/dL) >1.3 x ULN | 2 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Bicarbonate (mEq/L) >1.1 x ULN | 1 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urinalysis-bacteria (/HPF) >20 | 1 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Ery. MCH (pg) >1.1 × ULN | 1 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Ery. MCV (fL) <0.9 × LLN | 1 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urinalysis-casts (/LPF) >1 | 1 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Reticulocytes/erythrocytes (%) >1.5 × ULN | 1 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Lymphocytes (10^3/mm^3) <0.8 × LLN | 1 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urine 24 hours creatinine (mg/24 hr) >1.1 x ULN | 1 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Epithelial cells (/LPF) ≥6 | 1 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Lymphocytes (10^3/mm^3) >1.2 × ULN | 1 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Leukocyte esterase ≥1 | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Neutrophils (10^3/mm^3) <0.8 × LLN | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Nitrite ≥1 | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Eosinophils (10^3/mm^3) >1.2 x ULN | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urine hemoglobin ≥1 | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urate (mg/dL) >1.2 x ULN | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urine glucose ≥1 | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | HDL cholesterol (mg/dL) <0.8 × LLN | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Ery. MCH (pg) <0.9 × LLN | 1 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | cholesterol (mg/dL) >1.3 x ULN | 1 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | LDL cholesterol (mg/dL) >1.2 x ULN | 5 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Ery. MCV (fL) <0.9 × LLN | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Ery. MCH (pg) <0.9 × LLN | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Ery. MCH (pg) >1.1 × ULN | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Reticulocytes/erythrocytes (%) >1.5 × ULN | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Lymphocytes (10^3/mm^3) <0.8 × LLN | 1 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Lymphocytes (10^3/mm^3) >1.2 × ULN | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Neutrophils (10^3/mm^3) <0.8 × LLN | 2 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Eosinophils (10^3/mm^3) >1.2 x ULN | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Bilirubin (mg/dL) >1.5 x ULN | 1 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urate (mg/dL) >1.2 x ULN | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | HDL cholesterol (mg/dL) <0.8 × LLN | 1 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Triglycerides (mg/dL) >1.3 x ULN | 1 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Bicarbonate (mEq/L) >1.1 x ULN | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | cholesterol (mg/dL) >1.3 x ULN | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urine glucose ≥1 | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urine hemoglobin ≥1 | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Nitrite ≥1 | 2 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Leukocyte esterase ≥1 | 1 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Epithelial cells (/LPF) ≥6 | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urinalysis-casts (/LPF) >1 | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urinalysis-bacteria (/HPF) >20 | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urine 24 hours creatinine (mg/24 hr) >1.1 x ULN | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Eosinophils (10^3/mm^3) >1.2 x ULN | 1 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Epithelial cells (/LPF) ≥6 | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | LDL cholesterol (mg/dL) >1.2 x ULN | 4 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Nitrite ≥1 | 1 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Ery. MCH (pg) <0.9 × LLN | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Lymphocytes (10^3/mm^3) <0.8 × LLN | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urine glucose ≥1 | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Neutrophils (10^3/mm^3) <0.8 × LLN | 1 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Lymphocytes (10^3/mm^3) >1.2 × ULN | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Bicarbonate (mEq/L) >1.1 x ULN | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Ery. MCV (fL) <0.9 × LLN | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Leukocyte esterase ≥1 | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urinalysis-bacteria (/HPF) >20 | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urate (mg/dL) >1.2 x ULN | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Ery. MCH (pg) >1.1 × ULN | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | cholesterol (mg/dL) >1.3 x ULN | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urinalysis-casts (/LPF) >1 | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urine hemoglobin ≥1 | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | HDL cholesterol (mg/dL) <0.8 × LLN | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urine 24 hours creatinine (mg/24 hr) >1.1 x ULN | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Reticulocytes/erythrocytes (%) >1.5 × ULN | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Triglycerides (mg/dL) >1.3 x ULN | 1 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Triglycerides (mg/dL) >1.3 x ULN | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | cholesterol (mg/dL) >1.3 x ULN | 2 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | HDL cholesterol (mg/dL) <0.8 × LLN | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urate (mg/dL) >1.2 x ULN | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urine glucose ≥1 | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urine hemoglobin ≥1 | 1 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Eosinophils (10^3/mm^3) >1.2 x ULN | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Ery. MCV (fL) <0.9 × LLN | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Nitrite ≥1 | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Neutrophils (10^3/mm^3) <0.8 × LLN | 1 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Lymphocytes (10^3/mm^3) >1.2 × ULN | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Leukocyte esterase ≥1 | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Lymphocytes (10^3/mm^3) <0.8 × LLN | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Epithelial cells (/LPF) ≥6 | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Reticulocytes/erythrocytes (%) >1.5 × ULN | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urinalysis-casts (/LPF) >1 | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Ery. MCH (pg) >1.1 × ULN | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Ery. MCH (pg) <0.9 × LLN | 1 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urine 24 hours creatinine (mg/24 hr) >1.1 x ULN | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Urinalysis-bacteria (/HPF) >20 | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | Bicarbonate (mEq/L) >1.1 x ULN | 2 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (MAD Period) | LDL cholesterol (mg/dL) >1.2 x ULN | 5 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Laboratory Abnormalities (MAD Period) | Urate (mg/dL) >1.2 x ULN | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Laboratory Abnormalities (MAD Period) | Eosinophils (10^3/mm^3) >1.2 x ULN | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Laboratory Abnormalities (MAD Period) | Ery. MCH (pg) >1.1 × ULN | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Laboratory Abnormalities (MAD Period) | Urine hemoglobin ≥1 | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Laboratory Abnormalities (MAD Period) | Ery. MCV (fL) <0.9 × LLN | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Laboratory Abnormalities (MAD Period) | LDL cholesterol (mg/dL) >1.2 x ULN | 5 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Laboratory Abnormalities (MAD Period) | Urinalysis-casts (/LPF) >1 | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Laboratory Abnormalities (MAD Period) | cholesterol (mg/dL) >1.3 x ULN | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Laboratory Abnormalities (MAD Period) | Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Laboratory Abnormalities (MAD Period) | Ery. MCH (pg) <0.9 × LLN | 1 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Laboratory Abnormalities (MAD Period) | Urinalysis-bacteria (/HPF) >20 | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Laboratory Abnormalities (MAD Period) | Bicarbonate (mEq/L) >1.1 x ULN | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Laboratory Abnormalities (MAD Period) | Urine glucose ≥1 | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Laboratory Abnormalities (MAD Period) | Leukocyte esterase ≥1 | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Laboratory Abnormalities (MAD Period) | Lymphocytes (10^3/mm^3) >1.2 × ULN | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Laboratory Abnormalities (MAD Period) | Lymphocytes (10^3/mm^3) <0.8 × LLN | 1 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Laboratory Abnormalities (MAD Period) | Triglycerides (mg/dL) >1.3 x ULN | 2 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Laboratory Abnormalities (MAD Period) | Nitrite ≥1 | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Laboratory Abnormalities (MAD Period) | Urine 24 hours creatinine (mg/24 hr) >1.1 x ULN | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Laboratory Abnormalities (MAD Period) | Neutrophils (10^3/mm^3) <0.8 × LLN | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Laboratory Abnormalities (MAD Period) | HDL cholesterol (mg/dL) <0.8 × LLN | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Laboratory Abnormalities (MAD Period) | Epithelial cells (/LPF) ≥6 | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Laboratory Abnormalities (MAD Period) | Reticulocytes/erythrocytes (%) >1.5 × ULN | 0 Participants |
Primary
Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)
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: reticulocytes/erythrocytes (%) \>1.5 × ULN, lymphocytes \<0.8 × LLN, neutrophils \<0.8 × LLN or \>1.2 × ULN, eosinophils \>1.2 × ULN, bilirubin \>1.5 × ULN, alanine aminotransferase (ALT) \>3.0 × ULN, creatinine \>1.3 × ULN, urate \>1.2 × ULN, HDL cholesterol \<0.8 × LLN, LDL cholesterol \>1.2 × ULN, triglycerides \>1.3 × ULN, potassium \>1.1 × ULN, bicarbonate \>1.1 × ULN, glucose \<0.6 × LLN or \>1.5 × ULN, Creatine Kinase (CK) \>2.0 × ULN, cholesterol \>1.3 × ULN, urine glucose ≥1, ketones ≥1, urine hemoglobin ≥1, urine bilirubin ≥1, leukocyte esterase ≥1, epithelial cells ≥6/LPF, urinalysis-bacteria/HPF.
Time frame: Baseline up to Day 56
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PBO SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Neutrophils (10^3/mm^3) >1.2 x ULN | 1 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | CK (U/L) >2 x ULN | 4 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | HDL cholesterol (mg/dL) <0.8 x LLN | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Urinalysis-bacteria (/HPF) >20 | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Reticulocytes/erythrocytes (%) >1.5 x ULN | 2 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | LDL cholesterol (mg/dL) >1.2 x ULN | 11 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Urine bilirubin ≥1 | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Glucose (mg/dL) >1.5 x ULN | 1 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Triglycerides (mg/dL) >1.3 x ULN | 6 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Eosinophils (10^3/mm^3) >1.2 x ULN | 1 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Glucose (mg/dL) <0.6 x LLN | 1 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Potassium (mEq/L) >1.1 x ULN | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Epithelial cells (/LPF) ≥6 | 3 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Bicarbonate (mEq/L) >1.1 x ULN | 2 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Urine hemoglobin ≥1 | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Neutrophils (10^3/mm^3) <0.8 x LLN | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Ketones ≥1 | 1 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | ALT (U/L) >3 x ULN | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Lymphocytes (10^3/mm^3) <0.8 x LLN | 1 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Urine glucose ≥1 | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Creatinine (mg/dL) >1.3 x ULN | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Leukocyte esterase ≥1 | 2 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | cholesterol (mg/dL) >1.3 x ULN | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Urate (mg/dL) >1.2 x ULN | 7 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Glucose (mg/dL) >1.5 x ULN | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Reticulocytes/erythrocytes (%) >1.5 x ULN | 3 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Lymphocytes (10^3/mm^3) <0.8 x LLN | 1 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Neutrophils (10^3/mm^3) <0.8 x LLN | 1 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Neutrophils (10^3/mm^3) >1.2 x ULN | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Eosinophils (10^3/mm^3) >1.2 x ULN | 1 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Bilirubin (mg/dL) >1.5 x ULN | 1 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | ALT (U/L) >3 x ULN | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Creatinine (mg/dL) >1.3 x ULN | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Urate (mg/dL) >1.2 x ULN | 6 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | HDL cholesterol (mg/dL) <0.8 x LLN | 1 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | LDL cholesterol (mg/dL) >1.2 x ULN | 8 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Triglycerides (mg/dL) >1.3 x ULN | 4 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Potassium (mEq/L) >1.1 x ULN | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Bicarbonate (mEq/L) >1.1 x ULN | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Glucose (mg/dL) <0.6 x LLN | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | CK (U/L) >2 x ULN | 2 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | cholesterol (mg/dL) >1.3 x ULN | 1 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Urine glucose ≥1 | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Ketones ≥1 | 1 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Urine hemoglobin ≥1 | 1 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Urine bilirubin ≥1 | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Leukocyte esterase ≥1 | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Epithelial cells (/LPF) ≥6 | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Urinalysis-bacteria (/HPF) >20 | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | CK (U/L) >2 x ULN | 3 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Creatinine (mg/dL) >1.3 x ULN | 1 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Reticulocytes/erythrocytes (%) >1.5 x ULN | 1 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | cholesterol (mg/dL) >1.3 x ULN | 1 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | ALT (U/L) >3 x ULN | 1 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Leukocyte esterase ≥1 | 1 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Urine glucose ≥1 | 1 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Lymphocytes (10^3/mm^3) <0.8 x LLN | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Ketones ≥1 | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Eosinophils (10^3/mm^3) >1.2 x ULN | 1 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Urinalysis-bacteria (/HPF) >20 | 1 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Urine hemoglobin ≥1 | 2 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Neutrophils (10^3/mm^3) >1.2 x ULN | 1 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Potassium (mEq/L) >1.1 x ULN | 1 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Epithelial cells (/LPF) ≥6 | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Bicarbonate (mEq/L) >1.1 x ULN | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Triglycerides (mg/dL) >1.3 x ULN | 3 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Urine bilirubin ≥1 | 1 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Glucose (mg/dL) <0.6 x LLN | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | LDL cholesterol (mg/dL) >1.2 x ULN | 6 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | HDL cholesterol (mg/dL) <0.8 x LLN | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Glucose (mg/dL) >1.5 x ULN | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Urate (mg/dL) >1.2 x ULN | 3 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts) | Neutrophils (10^3/mm^3) <0.8 x LLN | 0 Participants |
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.
Time frame: Baseline up to Day 8
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PBO SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Ketones ≥1 | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Epithelial cells (/LPF) ≥6 | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Triglycerides (mg/dL) >1.3 x ULN | 2 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Reticulocytes/erythrocytes (%) >1.5 x ULN | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Limphocytes (10^3/mm^3) <0.8 × LLN | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Ery. MCH (picograms [pg]) <0.9 × LLN | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Cholesterol (mg/dL) >1.3 x ULN | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Ery. MCV (femtoliters [fL]) <0.9 × LLN | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Leukocyte esterase ≥1 | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | LDL cholesterol (mg/dL) >1.2 x ULN | 10 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | HDL cholesterol (mg/dL) <0.8 × LLN | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Eosinophils (10^3/mm^3) >1.2 x ULN | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Urate (mg/dL) >1.2 x ULN | 0 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Urinalysis-bacteria (/HPF) ≥20 | 1 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Nitrite ≥1 | 2 Participants |
| PBO SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | AST (U/L) >3 x ULN | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | LDL cholesterol (mg/dL) >1.2 x ULN | 4 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Epithelial cells (/LPF) ≥6 | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Urinalysis-bacteria (/HPF) ≥20 | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Cholesterol (mg/dL) >1.3 x ULN | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | AST (U/L) >3 x ULN | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Reticulocytes/erythrocytes (%) >1.5 x ULN | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Triglycerides (mg/dL) >1.3 x ULN | 2 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Urate (mg/dL) >1.2 x ULN | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | HDL cholesterol (mg/dL) <0.8 × LLN | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Leukocyte esterase ≥1 | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Limphocytes (10^3/mm^3) <0.8 × LLN | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Ery. MCH (picograms [pg]) <0.9 × LLN | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Nitrite ≥1 | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Eosinophils (10^3/mm^3) >1.2 x ULN | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Ery. MCV (femtoliters [fL]) <0.9 × LLN | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Ketones ≥1 | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Urinalysis-bacteria (/HPF) ≥20 | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | LDL cholesterol (mg/dL) >1.2 x ULN | 3 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | HDL cholesterol (mg/dL) <0.8 × LLN | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Ery. MCH (picograms [pg]) <0.9 × LLN | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Epithelial cells (/LPF) ≥6 | 1 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Reticulocytes/erythrocytes (%) >1.5 x ULN | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Ery. MCV (femtoliters [fL]) <0.9 × LLN | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Leukocyte esterase ≥1 | 1 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Limphocytes (10^3/mm^3) <0.8 × LLN | 1 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Nitrite ≥1 | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Eosinophils (10^3/mm^3) >1.2 x ULN | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Urate (mg/dL) >1.2 x ULN | 1 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Ketones ≥1 | 1 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Cholesterol (mg/dL) >1.3 x ULN | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | AST (U/L) >3 x ULN | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Triglycerides (mg/dL) >1.3 x ULN | 1 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Triglycerides (mg/dL) >1.3 x ULN | 2 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Ery. MCV (femtoliters [fL]) <0.9 × LLN | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Ery. MCH (picograms [pg]) <0.9 × LLN | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Reticulocytes/erythrocytes (%) >1.5 x ULN | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Limphocytes (10^3/mm^3) <0.8 × LLN | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Eosinophils (10^3/mm^3) >1.2 x ULN | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Bilirubin (mg/dL) >1.5 x ULN | 1 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | AST (U/L) >3 x ULN | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Urate (mg/dL) >1.2 x ULN | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | HDL cholesterol (mg/dL) <0.8 × LLN | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | LDL cholesterol (mg/dL) >1.2 x ULN | 6 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Cholesterol (mg/dL) >1.3 x ULN | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Ketones ≥1 | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Nitrite ≥1 | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Leukocyte esterase ≥1 | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Epithelial cells (/LPF) ≥6 | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Urinalysis-bacteria (/HPF) ≥20 | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Urinalysis-bacteria (/HPF) ≥20 | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Ery. MCV (femtoliters [fL]) <0.9 × LLN | 1 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Triglycerides (mg/dL) >1.3 x ULN | 1 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Ketones ≥1 | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Urate (mg/dL) >1.2 x ULN | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Limphocytes (10^3/mm^3) <0.8 × LLN | 1 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Eosinophils (10^3/mm^3) >1.2 x ULN | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Nitrite ≥1 | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | HDL cholesterol (mg/dL) <0.8 × LLN | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | AST (U/L) >3 x ULN | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Epithelial cells (/LPF) ≥6 | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Ery. MCH (picograms [pg]) <0.9 × LLN | 1 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Reticulocytes/erythrocytes (%) >1.5 x ULN | 1 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Cholesterol (mg/dL) >1.3 x ULN | 1 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | LDL cholesterol (mg/dL) >1.2 x ULN | 2 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Leukocyte esterase ≥1 | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | HDL cholesterol (mg/dL) <0.8 × LLN | 1 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | AST (U/L) >3 x ULN | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Triglycerides (mg/dL) >1.3 x ULN | 2 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Cholesterol (mg/dL) >1.3 x ULN | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Eosinophils (10^3/mm^3) >1.2 x ULN | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Ery. MCV (femtoliters [fL]) <0.9 × LLN | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Ketones ≥1 | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Limphocytes (10^3/mm^3) <0.8 × LLN | 1 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Nitrite ≥1 | 2 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Reticulocytes/erythrocytes (%) >1.5 x ULN | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Leukocyte esterase ≥1 | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Ery. MCH (picograms [pg]) <0.9 × LLN | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Urinalysis-bacteria (/HPF) ≥20 | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Epithelial cells (/LPF) ≥6 | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | LDL cholesterol (mg/dL) >1.2 x ULN | 5 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Urate (mg/dL) >1.2 x ULN | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Cholesterol (mg/dL) >1.3 x ULN | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | HDL cholesterol (mg/dL) <0.8 × LLN | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Leukocyte esterase ≥1 | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Ery. MCV (femtoliters [fL]) <0.9 × LLN | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Ery. MCH (picograms [pg]) <0.9 × LLN | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Triglycerides (mg/dL) >1.3 x ULN | 2 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Urate (mg/dL) >1.2 x ULN | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Bilirubin (mg/dL) >1.5 x ULN | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | LDL cholesterol (mg/dL) >1.2 x ULN | 4 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Urinalysis-bacteria (/HPF) ≥20 | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Limphocytes (10^3/mm^3) <0.8 × LLN | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Epithelial cells (/LPF) ≥6 | 1 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Nitrite ≥1 | 1 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Ketones ≥1 | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Reticulocytes/erythrocytes (%) >1.5 x ULN | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | AST (U/L) >3 x ULN | 1 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Laboratory Abnormalities (SAD Period) | Eosinophils (10^3/mm^3) >1.2 x ULN | 1 Participants |
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.
Time frame: Baseline up to Day 28
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | nose | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | mouth | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | skin | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | eyes | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | lymph nodes | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | musculoskeletal | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | cardiovascular | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | neurological | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | gastrointestinal | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | ears | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | head | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | general appearance | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | lungs | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | heart | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | head | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | skin | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | lungs | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | heart | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | ears | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | cardiovascular | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | nose | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | neurological | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | eyes | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | musculoskeletal | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | gastrointestinal | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | mouth | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | general appearance | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | lymph nodes | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | eyes | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | mouth | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | lungs | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | neurological | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | ears | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | heart | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | general appearance | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | skin | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | lymph nodes | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | head | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | musculoskeletal | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | nose | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | gastrointestinal | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | cardiovascular | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | musculoskeletal | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | cardiovascular | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | ears | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | eyes | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | gastrointestinal | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | general appearance | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | head | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | heart | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | lungs | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | lymph nodes | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | mouth | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | neurological | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | nose | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | skin | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | head | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | heart | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | eyes | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | neurological | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | general appearance | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | lymph nodes | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | cardiovascular | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | lungs | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | skin | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | mouth | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | nose | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | gastrointestinal | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | ears | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | musculoskeletal | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | eyes | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | musculoskeletal | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | head | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | ears | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | nose | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | neurological | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | heart | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | skin | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | mouth | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | general appearance | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | gastrointestinal | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | cardiovascular | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | lungs | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | lymph nodes | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | cardiovascular | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | lungs | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | general appearance | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | lymph nodes | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | gastrointestinal | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | mouth | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | eyes | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | musculoskeletal | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | ears | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | neurological | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | skin | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | nose | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | head | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | heart | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | cardiovascular | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | lungs | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | mouth | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | gastrointestinal | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | general appearance | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | nose | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | lymph nodes | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | head | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | heart | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | ears | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | skin | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | neurological | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | musculoskeletal | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period) | eyes | 0 Participants |
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.
Time frame: Baseline up to Day 56
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | mouth | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | general appearance | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | nose | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | lymph nodes | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | head | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | ears at Day 28 | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | lungs | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | heart | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | skin | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | neurological | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | eyes | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | ears at screening | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | musculoskeletal | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | gastrointestinal | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | cardiovascular | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | skin | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | cardiovascular | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | ears at screening | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | ears at Day 28 | 1 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | eyes | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | gastrointestinal | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | general appearance | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | head | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | heart | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | lungs | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | lymph nodes | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | mouth | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | musculoskeletal | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | neurological | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | nose | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | lymph nodes | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | gastrointestinal | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | skin | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | mouth | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | eyes | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | nose | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | musculoskeletal | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | ears at Day 28 | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | cardiovascular | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | heart | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | head | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | neurological | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | lungs | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | general appearance | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | ears at screening | 0 Participants |
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.
Time frame: Baseline up to Day 8
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | eyes | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | head | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | neurological | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | cardiovascular | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | nose | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | gastrointestinal | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | mouth | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | lungs | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | ears | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | musculoskeletal | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | heart | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | skin | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | general appearance | 0 Participants |
| PBO SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | lymph nodes | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | cardiovascular | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | heart | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | lungs | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | ears | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | nose | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | eyes | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | neurological | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | gastrointestinal | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | musculoskeletal | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | general appearance | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | mouth | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | head | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | skin | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | lymph nodes | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | nose | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | head | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | general appearance | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | skin | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | ears | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | mouth | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | lymph nodes | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | neurological | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | lungs | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | gastrointestinal | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | cardiovascular | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | eyes | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | musculoskeletal | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | heart | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | musculoskeletal | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | cardiovascular | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | ears | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | eyes | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | gastrointestinal | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | general appearance | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | head | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | heart | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | lungs | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | lymph nodes | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | mouth | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | neurological | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | nose | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | skin | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | general appearance | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | skin | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | lymph nodes | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | heart | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | musculoskeletal | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | ears | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | gastrointestinal | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | head | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | nose | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | lungs | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | eyes | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | mouth | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | cardiovascular | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | neurological | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | lymph nodes | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | head | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | general appearance | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | mouth | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | gastrointestinal | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | cardiovascular | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | musculoskeletal | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | eyes | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | neurological | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | ears | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | skin | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | nose | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | heart | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | lungs | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | skin | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | ears | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | lungs | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | cardiovascular | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | general appearance | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | head | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | nose | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | musculoskeletal | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | eyes | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | lymph nodes | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | gastrointestinal | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | mouth | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | heart | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period) | neurological | 0 Participants |
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.
Time frame: Baseline up to Day 28
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PBO SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with SAEs (AC) | 0 Participants |
| PBO SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with AEs (AC) | 2 Participants |
| PBO SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with AEs (TR) | 1 Participants |
| PBO SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with SAEs (TR) | 0 Participants |
| PBO SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with severe AEs (AC) | 0 Participants |
| PBO SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with severe AEs (TR) | 0 Participants |
| PBO SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants withdrew due to AEs (AC) | 0 Participants |
| PBO SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants withdrew due to AEs (TR) | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with severe AEs (AC) | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with SAEs (AC) | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants withdrew due to AEs (AC) | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with SAEs (TR) | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants withdrew due to AEs (TR) | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with AEs (AC) | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with AEs (TR) | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with severe AEs (TR) | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with AEs (AC) | 2 Participants |
| PF-06826647 10 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with severe AEs (AC) | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants withdrew due to AEs (AC) | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with SAEs (AC) | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with severe AEs (TR) | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants withdrew due to AEs (TR) | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with SAEs (TR) | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with AEs (TR) | 1 Participants |
| PF-06826647 30 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants withdrew due to AEs (TR) | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with SAEs (AC) | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with severe AEs (AC) | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with SAEs (TR) | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants withdrew due to AEs (AC) | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with severe AEs (TR) | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with AEs (TR) | 1 Participants |
| PF-06826647 30 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with AEs (AC) | 1 Participants |
| PF-06826647 100 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with SAEs (TR) | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants withdrew due to AEs (AC) | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with AEs (AC) | 1 Participants |
| PF-06826647 100 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with SAEs (AC) | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants withdrew due to AEs (TR) | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with severe AEs (AC) | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with severe AEs (TR) | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with AEs (TR) | 1 Participants |
| PF-06826647 400 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants withdrew due to AEs (TR) | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with AEs (TR) | 1 Participants |
| PF-06826647 400 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with SAEs (AC) | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with AEs (AC) | 1 Participants |
| PF-06826647 400 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants withdrew due to AEs (AC) | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with severe AEs (TR) | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with severe AEs (AC) | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with SAEs (TR) | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with SAEs (AC) | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with AEs (TR) | 2 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with SAEs (TR) | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with severe AEs (AC) | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with severe AEs (TR) | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants withdrew due to AEs (TR) | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants withdrew due to AEs (AC) | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with AEs (AC) | 3 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants withdrew due to AEs (TR) | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with severe AEs (TR) | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with severe AEs (AC) | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with SAEs (TR) | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with SAEs (AC) | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with AEs (TR) | 1 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants with AEs (AC) | 1 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period) | Participants withdrew due to AEs (AC) | 0 Participants |
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.
Time frame: Baseline up to Day 84
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PBO SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts) | Participants with SAEs (AC) | 0 Participants |
| PBO SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts) | Participants with AEs (AC) | 7 Participants |
| PBO SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts) | Participants with SAEs (TR) | 0 Participants |
| PBO SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts) | Participants withdrew due to AEs (TR) | 0 Participants |
| PBO SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts) | Participants with AEs (TR) | 5 Participants |
| PBO SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts) | Participants with severe AEs (AC) | 0 Participants |
| PBO SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts) | Participants withdrew due to AEs (AC) | 0 Participants |
| PBO SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts) | Participants with severe AEs (TR) | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts) | Participants with AEs (TR) | 5 Participants |
| PF-06826647 3 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts) | Participants with severe AEs (TR) | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts) | Participants with AEs (AC) | 12 Participants |
| PF-06826647 3 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts) | Participants withdrew due to AEs (AC) | 1 Participants |
| PF-06826647 3 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts) | Participants withdrew due to AEs (TR) | 1 Participants |
| PF-06826647 3 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts) | Participants with SAEs (AC) | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts) | Participants with SAEs (TR) | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts) | Participants with severe AEs (AC) | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts) | Participants with SAEs (TR) | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts) | Participants with AEs (AC) | 5 Participants |
| PF-06826647 10 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts) | Participants with AEs (TR) | 3 Participants |
| PF-06826647 10 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts) | Participants with SAEs (AC) | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts) | Participants withdrew due to AEs (TR) | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts) | Participants with severe AEs (AC) | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts) | Participants with severe AEs (TR) | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts) | Participants withdrew due to AEs (AC) | 0 Participants |
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.
Time frame: Baseline up to Day 8
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PBO SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with SAEs (AC) | 0 Participants |
| PBO SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with AEs (TR) | 0 Participants |
| PBO SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with AEs (AC) | 1 Participants |
| PBO SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with SAEs (TR) | 0 Participants |
| PBO SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with severe AEs (AC) | 0 Participants |
| PBO SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with severe AEs (TR) | 0 Participants |
| PBO SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants withdrew due to AEs (AC) | 0 Participants |
| PBO SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants withdrew due to AEs (TR) | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with AEs (TR) | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants withdrew due to AEs (TR) | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with SAEs (AC) | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with SAEs (TR) | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with severe AEs (AC) | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with severe AEs (TR) | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants withdrew due to AEs (AC) | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with AEs (AC) | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with SAEs (AC) | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants withdrew due to AEs (TR) | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with SAEs (TR) | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with severe AEs (AC) | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with severe AEs (TR) | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants withdrew due to AEs (AC) | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with AEs (TR) | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with AEs (AC) | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with SAEs (TR) | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants withdrew due to AEs (TR) | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with severe AEs (AC) | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with severe AEs (TR) | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants withdrew due to AEs (AC) | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with SAEs (AC) | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with AEs (AC) | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with AEs (TR) | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with severe AEs (AC) | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants withdrew due to AEs (TR) | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with severe AEs (TR) | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants withdrew due to AEs (AC) | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with SAEs (TR) | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with AEs (AC) | 1 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with AEs (TR) | 1 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with SAEs (AC) | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with severe AEs (TR) | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants withdrew due to AEs (TR) | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants withdrew due to AEs (AC) | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with severe AEs (AC) | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with AEs (AC) | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with AEs (TR) | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with SAEs (AC) | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with SAEs (TR) | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants withdrew due to AEs (AC) | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with severe AEs (TR) | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants withdrew due to AEs (TR) | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with AEs (AC) | 2 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with AEs (TR) | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with SAEs (AC) | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with SAEs (TR) | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period) | Participants with severe AEs (AC) | 0 Participants |
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.
Time frame: Baseline up to Day 28
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PBO SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine diastolic BP Chg ≥ 20 mmHg decrease | 4 Participants |
| PBO SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine diastolic BP Chg ≥ 20 mmHg increase | 1 Participants |
| PBO SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine diastolic BP Value < 50 mmHg | 1 Participants |
| PBO SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine pulse rate Value < 40 bpm | 0 Participants |
| PBO SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine pulse rate Value > 120 bpm | 0 Participants |
| PBO SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine systolic blood pressure Value < 90 mmHg | 1 Participants |
| PBO SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine systolic BP Chg ≥ 30 mmHg increase | 1 Participants |
| PBO SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine systolic BP Chg ≥ 30 mmHg decrease | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine pulse rate Value > 120 bpm | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine diastolic BP Chg ≥ 20 mmHg decrease | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine systolic blood pressure Value < 90 mmHg | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine systolic BP Chg ≥ 30 mmHg increase | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine diastolic BP Value < 50 mmHg | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine pulse rate Value < 40 bpm | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine diastolic BP Chg ≥ 20 mmHg increase | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine systolic BP Chg ≥ 30 mmHg decrease | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine systolic BP Chg ≥ 30 mmHg increase | 1 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine pulse rate Value > 120 bpm | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine systolic BP Chg ≥ 30 mmHg decrease | 1 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine diastolic BP Chg ≥ 20 mmHg decrease | 2 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine systolic blood pressure Value < 90 mmHg | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine pulse rate Value < 40 bpm | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine diastolic BP Value < 50 mmHg | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine diastolic BP Chg ≥ 20 mmHg increase | 1 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine systolic BP Chg ≥ 30 mmHg decrease | 1 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine diastolic BP Chg ≥ 20 mmHg increase | 1 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine diastolic BP Value < 50 mmHg | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine pulse rate Value < 40 bpm | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine diastolic BP Chg ≥ 20 mmHg decrease | 1 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine pulse rate Value > 120 bpm | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine systolic blood pressure Value < 90 mmHg | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine systolic BP Chg ≥ 30 mmHg increase | 1 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine pulse rate Value < 40 bpm | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine systolic BP Chg ≥ 30 mmHg increase | 2 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine diastolic BP Chg ≥ 20 mmHg decrease | 1 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine diastolic BP Value < 50 mmHg | 1 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine systolic BP Chg ≥ 30 mmHg decrease | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine pulse rate Value > 120 bpm | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine systolic blood pressure Value < 90 mmHg | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine diastolic BP Chg ≥ 20 mmHg increase | 1 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine systolic BP Chg ≥ 30 mmHg decrease | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine diastolic BP Chg ≥ 20 mmHg increase | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine diastolic BP Chg ≥ 20 mmHg decrease | 1 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine diastolic BP Value < 50 mmHg | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine systolic BP Chg ≥ 30 mmHg increase | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine systolic blood pressure Value < 90 mmHg | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine pulse rate Value > 120 bpm | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine pulse rate Value < 40 bpm | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine diastolic BP Chg ≥ 20 mmHg decrease | 1 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine diastolic BP Chg ≥ 20 mmHg increase | 3 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine pulse rate Value < 40 bpm | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine pulse rate Value > 120 bpm | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine systolic blood pressure Value < 90 mmHg | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine systolic BP Chg ≥ 30 mmHg decrease | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine systolic BP Chg ≥ 30 mmHg increase | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine diastolic BP Value < 50 mmHg | 1 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine systolic BP Chg ≥ 30 mmHg decrease | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine systolic blood pressure Value < 90 mmHg | 1 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine pulse rate Value > 120 bpm | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine pulse rate Value < 40 bpm | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine diastolic BP Chg ≥ 20 mmHg decrease | 2 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine diastolic BP Chg ≥ 20 mmHg increase | 0 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine diastolic BP Value < 50 mmHg | 1 Participants |
| PF-06826647 400 mg QD MAD JP | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period) | Supine systolic BP Chg ≥ 30 mmHg increase | 0 Participants |
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.
Time frame: Baseline up to Day 56
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PBO SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | Supine systolic BP Chg ≥ 30 mmHg decrease | 6 Participants |
| PBO SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | Supine diastolic blood pressure Value < 50 mmHg | 0 Participants |
| PBO SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | Supine pulse rate Value < 40 bpm | 0 Participants |
| PBO SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | Supine systolic BP Chg ≥ 30 mmHg increase | 0 Participants |
| PBO SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | Supine diastolic BP Chg ≥ 20 mmHg increase | 0 Participants |
| PBO SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | Supine pulse rate Value > 120 bpm | 0 Participants |
| PBO SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | Supine diastolic BP Chg ≥ 20 mmHg decrease | 6 Participants |
| PBO SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | Supine systolic BP Value < 90 mmHg | 1 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | Supine diastolic BP Chg ≥ 20 mmHg increase | 3 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | Supine systolic BP Value < 90 mmHg | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | Supine systolic BP Chg ≥ 30 mmHg increase | 1 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | Supine diastolic blood pressure Value < 50 mmHg | 1 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | Supine systolic BP Chg ≥ 30 mmHg decrease | 5 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | Supine diastolic BP Chg ≥ 20 mmHg decrease | 7 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | Supine pulse rate Value < 40 bpm | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | Supine pulse rate Value > 120 bpm | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | Supine systolic BP Chg ≥ 30 mmHg decrease | 1 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | Supine diastolic blood pressure Value < 50 mmHg | 1 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | Supine diastolic BP Chg ≥ 20 mmHg increase | 5 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | Supine diastolic BP Chg ≥ 20 mmHg decrease | 4 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | Supine pulse rate Value < 40 bpm | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | Supine pulse rate Value > 120 bpm | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | Supine systolic BP Chg ≥ 30 mmHg increase | 2 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts) | Supine systolic BP Value < 90 mmHg | 0 Participants |
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.
Time frame: Baseline up to Day 8
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PBO SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine diastolic BP Chg ≥20 mmHg decrease | 2 Participants |
| PBO SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine diastolic BP Change (Chg) ≥20 mmHg increase | 3 Participants |
| PBO SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine diastolic BP Value <50 mmHg | 2 Participants |
| PBO SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine pulse rate Value <40 beats per minute (bpm) | 1 Participants |
| PBO SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine pulse rate Value >120 bpm | 0 Participants |
| PBO SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine systolic BP Value <90mmHg | 1 Participants |
| PBO SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine systolic BP Chg ≥30 mmHg increase | 2 Participants |
| PBO SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine systolic BP Chg ≥30mmHg decrease | 2 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine diastolic BP Change (Chg) ≥20 mmHg increase | 1 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine systolic BP Chg ≥30mmHg decrease | 1 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine diastolic BP Chg ≥20 mmHg decrease | 1 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine pulse rate Value <40 beats per minute (bpm) | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine pulse rate Value >120 bpm | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine systolic BP Value <90mmHg | 1 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine systolic BP Chg ≥30 mmHg increase | 0 Participants |
| PF-06826647 3 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine diastolic BP Value <50 mmHg | 2 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine diastolic BP Chg ≥20 mmHg decrease | 2 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine systolic BP Chg ≥30mmHg decrease | 1 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine pulse rate Value <40 beats per minute (bpm) | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine pulse rate Value >120 bpm | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine systolic BP Value <90mmHg | 2 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine systolic BP Chg ≥30 mmHg increase | 0 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine diastolic BP Change (Chg) ≥20 mmHg increase | 1 Participants |
| PF-06826647 10 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine diastolic BP Value <50 mmHg | 1 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine pulse rate Value <40 beats per minute (bpm) | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine systolic BP Chg ≥30mmHg decrease | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine pulse rate Value >120 bpm | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine systolic BP Value <90mmHg | 1 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine systolic BP Chg ≥30 mmHg increase | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine diastolic BP Chg ≥20 mmHg decrease | 1 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine diastolic BP Value <50 mmHg | 0 Participants |
| PF-06826647 30 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine diastolic BP Change (Chg) ≥20 mmHg increase | 2 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine pulse rate Value >120 bpm | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine systolic BP Chg ≥30mmHg decrease | 1 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine systolic BP Value <90mmHg | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine systolic BP Chg ≥30 mmHg increase | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine pulse rate Value <40 beats per minute (bpm) | 0 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine diastolic BP Value <50 mmHg | 1 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine diastolic BP Change (Chg) ≥20 mmHg increase | 1 Participants |
| PF-06826647 100 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine diastolic BP Chg ≥20 mmHg decrease | 2 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine systolic BP Value <90mmHg | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine systolic BP Chg ≥30mmHg decrease | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine systolic BP Chg ≥30 mmHg increase | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine pulse rate Value >120 bpm | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine diastolic BP Value <50 mmHg | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine diastolic BP Change (Chg) ≥20 mmHg increase | 0 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine diastolic BP Chg ≥20 mmHg decrease | 1 Participants |
| PF-06826647 400 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine pulse rate Value <40 beats per minute (bpm) | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine systolic BP Chg ≥30 mmHg increase | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine systolic BP Value <90mmHg | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine systolic BP Chg ≥30mmHg decrease | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine diastolic BP Value <50 mmHg | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine diastolic BP Change (Chg) ≥20 mmHg increase | 2 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine diastolic BP Chg ≥20 mmHg decrease | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine pulse rate Value <40 beats per minute (bpm) | 0 Participants |
| PF-06826647 1600 mg SAD | Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) | Supine pulse rate Value >120 bpm | 0 Participants |
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.
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Apparent Clearance (CL/F) (SAD Period) | 62.98 liters per hour (L/hr) | Geometric Coefficient of Variation 59 |
| PF-06826647 3 mg SAD | Apparent Clearance (CL/F) (SAD Period) | 27.08 liters per hour (L/hr) | Geometric Coefficient of Variation 67 |
| PF-06826647 10 mg SAD | Apparent Clearance (CL/F) (SAD Period) | 35.36 liters per hour (L/hr) | Geometric Coefficient of Variation 41 |
| PF-06826647 30 mg SAD | Apparent Clearance (CL/F) (SAD Period) | 63.21 liters per hour (L/hr) | Geometric Coefficient of Variation 42 |
| PF-06826647 100 mg SAD | Apparent Clearance (CL/F) (SAD Period) | 130.8 liters per hour (L/hr) | Geometric Coefficient of Variation 65 |
| PF-06826647 400 mg SAD | Apparent Clearance (CL/F) (SAD Period) | 135.4 liters per hour (L/hr) | Geometric Coefficient of Variation 26 |
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.
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Apparent Volume of Distribution (Vz/F) (SAD Period) | 312.1 liters (L) | Geometric Coefficient of Variation 34 |
| PF-06826647 3 mg SAD | Apparent Volume of Distribution (Vz/F) (SAD Period) | 226.1 liters (L) | Geometric Coefficient of Variation 41 |
| PF-06826647 10 mg SAD | Apparent Volume of Distribution (Vz/F) (SAD Period) | 902.9 liters (L) | Geometric Coefficient of Variation 81 |
| PF-06826647 30 mg SAD | Apparent Volume of Distribution (Vz/F) (SAD Period) | 2671 liters (L) | Geometric Coefficient of Variation 134 |
| PF-06826647 100 mg SAD | Apparent Volume of Distribution (Vz/F) (SAD Period) | 2732 liters (L) | Geometric Coefficient of Variation 128 |
| PF-06826647 400 mg SAD | Apparent Volume of Distribution (Vz/F) (SAD Period) | 2877 liters (L) | Geometric Coefficient of Variation 146 |
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.
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Area Under the Concentration-Time Profile From Time 0 to 24 Hours (AUC24) (SAD Period) | 43.10 ng*hr/mL | Geometric Coefficient of Variation 56 |
| PF-06826647 3 mg SAD | Area Under the Concentration-Time Profile From Time 0 to 24 Hours (AUC24) (SAD Period) | 347.8 ng*hr/mL | Geometric Coefficient of Variation 62 |
| PF-06826647 10 mg SAD | Area Under the Concentration-Time Profile From Time 0 to 24 Hours (AUC24) (SAD Period) | 543.2 ng*hr/mL | Geometric Coefficient of Variation 49 |
| PF-06826647 30 mg SAD | Area Under the Concentration-Time Profile From Time 0 to 24 Hours (AUC24) (SAD Period) | 1158 ng*hr/mL | Geometric Coefficient of Variation 55 |
| PF-06826647 100 mg SAD | Area Under the Concentration-Time Profile From Time 0 to 24 Hours (AUC24) (SAD Period) | 2519 ng*hr/mL | Geometric Coefficient of Variation 67 |
| PF-06826647 400 mg SAD | Area Under the Concentration-Time Profile From Time 0 to 24 Hours (AUC24) (SAD Period) | 9318 ng*hr/mL | Geometric Coefficient of Variation 34 |
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.
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) (SAD Period) | 40.25 ng*hr/mL | Geometric Coefficient of Variation 56 |
| PF-06826647 3 mg SAD | Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) (SAD Period) | 354.8 ng*hr/mL | Geometric Coefficient of Variation 67 |
| PF-06826647 10 mg SAD | Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) (SAD Period) | 638.5 ng*hr/mL | Geometric Coefficient of Variation 58 |
| PF-06826647 30 mg SAD | Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) (SAD Period) | 1375 ng*hr/mL | Geometric Coefficient of Variation 53 |
| PF-06826647 100 mg SAD | Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) (SAD Period) | 2767 ng*hr/mL | Geometric Coefficient of Variation 65 |
| PF-06826647 400 mg SAD | Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) (SAD Period) | 9921 ng*hr/mL | Geometric Coefficient of Variation 32 |
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).
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) (SAD Period) | 47.63 nanograms*hours per mL (ng*hr/mL) | Geometric Coefficient of Variation 59 |
| PF-06826647 3 mg SAD | Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) (SAD Period) | 369.3 nanograms*hours per mL (ng*hr/mL) | Geometric Coefficient of Variation 67 |
| PF-06826647 10 mg SAD | Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) (SAD Period) | 848.4 nanograms*hours per mL (ng*hr/mL) | Geometric Coefficient of Variation 40 |
| PF-06826647 30 mg SAD | Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) (SAD Period) | 1582 nanograms*hours per mL (ng*hr/mL) | Geometric Coefficient of Variation 42 |
| PF-06826647 100 mg SAD | Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) (SAD Period) | 3056 nanograms*hours per mL (ng*hr/mL) | Geometric Coefficient of Variation 65 |
| PF-06826647 400 mg SAD | Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) (SAD Period) | 11790 nanograms*hours per mL (ng*hr/mL) | Geometric Coefficient of Variation 25 |
Secondary
Area Under the Plasma Concentration-Time Profile Over the Dosing Interval τ (AUCτ) (MAD Period Day 1)
AUCτ was summarized by dosing regimen and period. Dosing interval was the interval τ 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.
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Area Under the Plasma Concentration-Time Profile Over the Dosing Interval τ (AUCτ) (MAD Period Day 1) | 662.8 ng*hr/mL | Geometric Coefficient of Variation 25 |
| PF-06826647 3 mg SAD | Area Under the Plasma Concentration-Time Profile Over the Dosing Interval τ (AUCτ) (MAD Period Day 1) | 1803 ng*hr/mL | Geometric Coefficient of Variation 23 |
| PF-06826647 10 mg SAD | Area Under the Plasma Concentration-Time Profile Over the Dosing Interval τ (AUCτ) (MAD Period Day 1) | 1646 ng*hr/mL | Geometric Coefficient of Variation 70 |
| PF-06826647 30 mg SAD | Area Under the Plasma Concentration-Time Profile Over the Dosing Interval τ (AUCτ) (MAD Period Day 1) | 4424 ng*hr/mL | Geometric Coefficient of Variation 67 |
| PF-06826647 100 mg SAD | Area Under the Plasma Concentration-Time Profile Over the Dosing Interval τ (AUCτ) (MAD Period Day 1) | 6038 ng*hr/mL | Geometric Coefficient of Variation 29 |
| PF-06826647 400 mg SAD | Area Under the Plasma Concentration-Time Profile Over the Dosing Interval τ (AUCτ) (MAD Period Day 1) | 17090 ng*hr/mL | Geometric Coefficient of Variation 20 |
Secondary
AUCτ(dn) (MAD Period Day 10)
Area Under the Plasma Concentration-Time Profile over the Dosing interval τ (AUCτ). 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. AUCτ(dn) = AUCτ / Dose. To assess the relationship between the PK parameters and the dose, dose normalized AUCτ was plotted against dose, and included individual participant values and the geometric means for each dose.
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | AUCτ(dn) (MAD Period Day 10) | 25.06 ng*hr/mL/mg | Geometric Coefficient of Variation 32 |
| PF-06826647 3 mg SAD | AUCτ(dn) (MAD Period Day 10) | 19.52 ng*hr/mL/mg | Geometric Coefficient of Variation 33 |
| PF-06826647 10 mg SAD | AUCτ(dn) (MAD Period Day 10) | 10.04 ng*hr/mL/mg | Geometric Coefficient of Variation 49 |
| PF-06826647 30 mg SAD | AUCτ(dn) (MAD Period Day 10) | 13.56 ng*hr/mL/mg | Geometric Coefficient of Variation 57 |
| PF-06826647 100 mg SAD | AUCτ(dn) (MAD Period Day 10) | 18.00 ng*hr/mL/mg | Geometric Coefficient of Variation 19 |
| PF-06826647 400 mg SAD | AUCτ(dn) (MAD Period Day 10) | 12.41 ng*hr/mL/mg | Geometric Coefficient of Variation 31 |
Secondary
AUCτ(dn) (Psoriasis Cohorts)
AUCτ(dn) = AUCτ / Dose. To assess the relationship between the PK parameters and the dose, dose normalized AUCτ was plotted against dose, and included individual participant values and the geometric means for each dose.
Time frame: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | AUCτ(dn) (Psoriasis Cohorts) | 24.01 ng*hr/mL/mg | Geometric Coefficient of Variation 53 |
| PF-06826647 3 mg SAD | AUCτ(dn) (Psoriasis Cohorts) | 19.17 ng*hr/mL/mg | Geometric Coefficient of Variation 34 |
Secondary
AUCτ (MAD Period Day 10)
AUCτ was summarized by dosing regimen and period. Dosing interval was the interval τ 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.
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | AUCτ (MAD Period Day 10) | 752.9 ng*hr/mL | Geometric Coefficient of Variation 32 |
| PF-06826647 3 mg SAD | AUCτ (MAD Period Day 10) | 1952 ng*hr/mL | Geometric Coefficient of Variation 33 |
| PF-06826647 10 mg SAD | AUCτ (MAD Period Day 10) | 2010 ng*hr/mL | Geometric Coefficient of Variation 49 |
| PF-06826647 30 mg SAD | AUCτ (MAD Period Day 10) | 5420 ng*hr/mL | Geometric Coefficient of Variation 57 |
| PF-06826647 100 mg SAD | AUCτ (MAD Period Day 10) | 7194 ng*hr/mL | Geometric Coefficient of Variation 20 |
| PF-06826647 400 mg SAD | AUCτ (MAD Period Day 10) | 14890 ng*hr/mL | Geometric Coefficient of Variation 31 |
Secondary
AUCτ (Psoriasis Cohorts)
AUCτ was summarized by dosing regimen and period. It was determined by linear/log trapezoidal method.
Time frame: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | AUCτ (Psoriasis Cohorts) | 2401 ng*hr/mL | Geometric Coefficient of Variation 53 |
| PF-06826647 3 mg SAD | AUCτ (Psoriasis Cohorts) | 7664 ng*hr/mL | Geometric Coefficient of Variation 34 |
Secondary
Average Concentration at Steady State (Cav) (MAD Period Day 10)
Cav = AUCτ,ss / τ, where ss means 'at steady state', and where the dosing interval τ was 24 hours for QD dosing and 12 hours for BID dosing. Cav was summarized by dosing regimen and period.
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Average Concentration at Steady State (Cav) (MAD Period Day 10) | 31.36 ng/mL | Geometric Coefficient of Variation 32 |
| PF-06826647 3 mg SAD | Average Concentration at Steady State (Cav) (MAD Period Day 10) | 81.28 ng/mL | Geometric Coefficient of Variation 34 |
| PF-06826647 10 mg SAD | Average Concentration at Steady State (Cav) (MAD Period Day 10) | 167.6 ng/mL | Geometric Coefficient of Variation 49 |
| PF-06826647 30 mg SAD | Average Concentration at Steady State (Cav) (MAD Period Day 10) | 226.0 ng/mL | Geometric Coefficient of Variation 57 |
| PF-06826647 100 mg SAD | Average Concentration at Steady State (Cav) (MAD Period Day 10) | 299.7 ng/mL | Geometric Coefficient of Variation 20 |
| PF-06826647 400 mg SAD | Average Concentration at Steady State (Cav) (MAD Period Day 10) | 619.9 ng/mL | Geometric Coefficient of Variation 31 |
Secondary
Cav (Psoriasis Cohorts)
Cav = AUCτ,ss / τ, where ss means 'at steady state'. Cav was summarized by dosing regimen and period.
Time frame: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Cav (Psoriasis Cohorts) | 100.2 ng/mL | Geometric Coefficient of Variation 53 |
| PF-06826647 3 mg SAD | Cav (Psoriasis Cohorts) | 319.3 ng/mL | Geometric Coefficient of Variation 34 |
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.
Time frame: Baseline and Day 28
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 28 | -11.13 score on a scale | Standard Error 2.405 |
| PF-06826647 3 mg SAD | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 28 | -24.18 score on a scale | Standard Error 2.281 |
| PF-06826647 10 mg SAD | Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 28 | -14.62 score on a scale | Standard Error 2.505 |
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.
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | CL/F (MAD Period Day 10) | 39.86 liters per hour (L/hr) | Geometric Coefficient of Variation 32 |
| PF-06826647 3 mg SAD | CL/F (MAD Period Day 10) | 51.27 liters per hour (L/hr) | Geometric Coefficient of Variation 34 |
| PF-06826647 10 mg SAD | CL/F (MAD Period Day 10) | 99.47 liters per hour (L/hr) | Geometric Coefficient of Variation 49 |
| PF-06826647 30 mg SAD | CL/F (MAD Period Day 10) | 73.78 liters per hour (L/hr) | Geometric Coefficient of Variation 57 |
| PF-06826647 100 mg SAD | CL/F (MAD Period Day 10) | 55.62 liters per hour (L/hr) | Geometric Coefficient of Variation 20 |
| PF-06826647 400 mg SAD | CL/F (MAD Period Day 10) | 80.63 liters per hour (L/hr) | Geometric Coefficient of Variation 31 |
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.
Time frame: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | CL/F (Psoriasis Cohorts) | 41.61 L/hr | Geometric Coefficient of Variation 53 |
| PF-06826647 3 mg SAD | CL/F (Psoriasis Cohorts) | 52.21 L/hr | Geometric Coefficient of Variation 34 |
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.
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Cmax(dn) (MAD Period Day 1) | 2.787 ng/mL/mg | Geometric Coefficient of Variation 24 |
| PF-06826647 3 mg SAD | Cmax(dn) (MAD Period Day 1) | 2.672 ng/mL/mg | Geometric Coefficient of Variation 20 |
| PF-06826647 10 mg SAD | Cmax(dn) (MAD Period Day 1) | 1.450 ng/mL/mg | Geometric Coefficient of Variation 67 |
| PF-06826647 30 mg SAD | Cmax(dn) (MAD Period Day 1) | 1.468 ng/mL/mg | Geometric Coefficient of Variation 33 |
| PF-06826647 100 mg SAD | Cmax(dn) (MAD Period Day 1) | 1.741 ng/mL/mg | Geometric Coefficient of Variation 19 |
| PF-06826647 400 mg SAD | Cmax(dn) (MAD Period Day 1) | 1.686 ng/mL/mg | Geometric Coefficient of Variation 10 |
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.
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Cmax(dn) (MAD Period Day 10) | 2.844 ng/mL/mg | Geometric Coefficient of Variation 27 |
| PF-06826647 3 mg SAD | Cmax(dn) (MAD Period Day 10) | 2.632 ng/mL/mg | Geometric Coefficient of Variation 30 |
| PF-06826647 10 mg SAD | Cmax(dn) (MAD Period Day 10) | 1.701 ng/mL/mg | Geometric Coefficient of Variation 46 |
| PF-06826647 30 mg SAD | Cmax(dn) (MAD Period Day 10) | 1.669 ng/mL/mg | Geometric Coefficient of Variation 37 |
| PF-06826647 100 mg SAD | Cmax(dn) (MAD Period Day 10) | 2.220 ng/mL/mg | Geometric Coefficient of Variation 11 |
| PF-06826647 400 mg SAD | Cmax(dn) (MAD Period Day 10) | 1.547 ng/mL/mg | Geometric Coefficient of Variation 21 |
Secondary
Cmax(dn) (Psoriasis Cohorts)
Cmax was summarized by dosing regimen and period. It was observed directly from data.
Time frame: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Cmax(dn) (Psoriasis Cohorts) | 2.966 ng/mL/mg | Geometric Coefficient of Variation 38 |
| PF-06826647 3 mg SAD | Cmax(dn) (Psoriasis Cohorts) | 2.176 ng/mL/mg | Geometric Coefficient of Variation 25 |
Secondary
Cmax (MAD Period Day 1)
Cmax was summarized by dosing regimen and period. It was observed directly from data.
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Cmax (MAD Period Day 1) | 83.53 ng/mL | Geometric Coefficient of Variation 24 |
| PF-06826647 3 mg SAD | Cmax (MAD Period Day 1) | 267.2 ng/mL | Geometric Coefficient of Variation 20 |
| PF-06826647 10 mg SAD | Cmax (MAD Period Day 1) | 289.8 ng/mL | Geometric Coefficient of Variation 67 |
| PF-06826647 30 mg SAD | Cmax (MAD Period Day 1) | 585.9 ng/mL | Geometric Coefficient of Variation 33 |
| PF-06826647 100 mg SAD | Cmax (MAD Period Day 1) | 695.5 ng/mL | Geometric Coefficient of Variation 19 |
| PF-06826647 400 mg SAD | Cmax (MAD Period Day 1) | 2023 ng/mL | Geometric Coefficient of Variation 10 |
Secondary
Cmax (MAD Period Day 10)
Cmax was summarized by dosing regimen and period. It was observed directly from data.
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Cmax (MAD Period Day 10) | 85.34 ng/mL | Geometric Coefficient of Variation 27 |
| PF-06826647 3 mg SAD | Cmax (MAD Period Day 10) | 263.2 ng/mL | Geometric Coefficient of Variation 30 |
| PF-06826647 10 mg SAD | Cmax (MAD Period Day 10) | 339.5 ng/mL | Geometric Coefficient of Variation 46 |
| PF-06826647 30 mg SAD | Cmax (MAD Period Day 10) | 667.3 ng/mL | Geometric Coefficient of Variation 37 |
| PF-06826647 100 mg SAD | Cmax (MAD Period Day 10) | 887.0 ng/mL | Geometric Coefficient of Variation 11 |
| PF-06826647 400 mg SAD | Cmax (MAD Period Day 10) | 1855 ng/mL | Geometric Coefficient of Variation 21 |
Secondary
Cmax (Psoriasis Cohorts)
Cmax was summarized by dosing regimen and period. It was observed directly from data.
Time frame: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Cmax (Psoriasis Cohorts) | 296.6 ng/mL | Geometric Coefficient of Variation 38 |
| PF-06826647 3 mg SAD | Cmax (Psoriasis Cohorts) | 869.8 ng/mL | Geometric Coefficient of Variation 25 |
Secondary
Cmin (Psoriasis Cohorts)
Cmin was observed directly from data. It was summarized by dosing regimen and period.
Time frame: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Cmin (Psoriasis Cohorts) | 21.92 ng/mL | Geometric Coefficient of Variation 103 |
| PF-06826647 3 mg SAD | Cmin (Psoriasis Cohorts) | 38.12 ng/mL | Geometric Coefficient of Variation 176 |
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.
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Cumulative Amount of Drug Recovered Unchanged in Urine From Time 0 to the Dosing Interval τ Hours Post-Dose (Aeτ) (MAD Period Day 10) | 0.2204 mg | Geometric Coefficient of Variation 35 |
| PF-06826647 3 mg SAD | Cumulative Amount of Drug Recovered Unchanged in Urine From Time 0 to the Dosing Interval τ Hours Post-Dose (Aeτ) (MAD Period Day 10) | 1.072 mg | Geometric Coefficient of Variation 65 |
| PF-06826647 10 mg SAD | Cumulative Amount of Drug Recovered Unchanged in Urine From Time 0 to the Dosing Interval τ Hours Post-Dose (Aeτ) (MAD Period Day 10) | 2.560 mg | Geometric Coefficient of Variation 66 |
| PF-06826647 30 mg SAD | Cumulative Amount of Drug Recovered Unchanged in Urine From Time 0 to the Dosing Interval τ Hours Post-Dose (Aeτ) (MAD Period Day 10) | 3.134 mg | Geometric Coefficient of Variation 75 |
| PF-06826647 100 mg SAD | Cumulative Amount of Drug Recovered Unchanged in Urine From Time 0 to the Dosing Interval τ Hours Post-Dose (Aeτ) (MAD Period Day 10) | 2.931 mg | Geometric Coefficient of Variation 624 |
| PF-06826647 400 mg SAD | Cumulative Amount of Drug Recovered Unchanged in Urine From Time 0 to the Dosing Interval τ Hours Post-Dose (Aeτ) (MAD Period Day 10) | 14.73 mg | Geometric Coefficient of Variation 92 |
Secondary
Dose Normalized AUClast (AUClast[dn]) (SAD Period)
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.
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Dose Normalized AUClast (AUClast[dn]) (SAD Period) | 13.40 ng*hr/mL/mg | Geometric Coefficient of Variation 56 |
| PF-06826647 3 mg SAD | Dose Normalized AUClast (AUClast[dn]) (SAD Period) | 35.48 ng*hr/mL/mg | Geometric Coefficient of Variation 67 |
| PF-06826647 10 mg SAD | Dose Normalized AUClast (AUClast[dn]) (SAD Period) | 21.28 ng*hr/mL/mg | Geometric Coefficient of Variation 58 |
| PF-06826647 30 mg SAD | Dose Normalized AUClast (AUClast[dn]) (SAD Period) | 13.75 ng*hr/mL/mg | Geometric Coefficient of Variation 53 |
| PF-06826647 100 mg SAD | Dose Normalized AUClast (AUClast[dn]) (SAD Period) | 6.919 ng*hr/mL/mg | Geometric Coefficient of Variation 65 |
| PF-06826647 400 mg SAD | Dose Normalized AUClast (AUClast[dn]) (SAD Period) | 6.200 ng*hr/mL/mg | Geometric Coefficient of Variation 32 |
Secondary
Dose Normalized AUCτ (AUCτ[dn]) (MAD Period Day 1)
Area Under the Plasma Concentration-Time Profile over the Dosing interval τ (AUCτ). 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. AUCτ(dn) = AUCτ / Dose. To assess the relationship between the PK parameters and the dose, dose normalized AUCτ was plotted against dose, and included individual participant values and the geometric means for each dose.
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Dose Normalized AUCτ (AUCτ[dn]) (MAD Period Day 1) | 22.10 ng*hr/mL/mg | Geometric Coefficient of Variation 25 |
| PF-06826647 3 mg SAD | Dose Normalized AUCτ (AUCτ[dn]) (MAD Period Day 1) | 18.03 ng*hr/mL/mg | Geometric Coefficient of Variation 23 |
| PF-06826647 10 mg SAD | Dose Normalized AUCτ (AUCτ[dn]) (MAD Period Day 1) | 8.229 ng*hr/mL/mg | Geometric Coefficient of Variation 70 |
| PF-06826647 30 mg SAD | Dose Normalized AUCτ (AUCτ[dn]) (MAD Period Day 1) | 11.07 ng*hr/mL/mg | Geometric Coefficient of Variation 67 |
| PF-06826647 100 mg SAD | Dose Normalized AUCτ (AUCτ[dn]) (MAD Period Day 1) | 15.10 ng*hr/mL/mg | Geometric Coefficient of Variation 29 |
| PF-06826647 400 mg SAD | Dose Normalized AUCτ (AUCτ[dn]) (MAD Period Day 1) | 14.23 ng*hr/mL/mg | Geometric Coefficient of Variation 20 |
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.
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Dose Normalized Cmax (Cmax[dn]) (SAD Period) | 2.617 ng/mL/mg | Geometric Coefficient of Variation 38 |
| PF-06826647 3 mg SAD | Dose Normalized Cmax (Cmax[dn]) (SAD Period) | 4.709 ng/mL/mg | Geometric Coefficient of Variation 35 |
| PF-06826647 10 mg SAD | Dose Normalized Cmax (Cmax[dn]) (SAD Period) | 2.597 ng/mL/mg | Geometric Coefficient of Variation 34 |
| PF-06826647 30 mg SAD | Dose Normalized Cmax (Cmax[dn]) (SAD Period) | 1.668 ng/mL/mg | Geometric Coefficient of Variation 55 |
| PF-06826647 100 mg SAD | Dose Normalized Cmax (Cmax[dn]) (SAD Period) | 1.012 ng/mL/mg | Geometric Coefficient of Variation 62 |
| PF-06826647 400 mg SAD | Dose Normalized Cmax (Cmax[dn]) (SAD Period) | 0.7618 ng/mL/mg | Geometric Coefficient of Variation 25 |
Secondary
Lowest Concentration Observed During the Dosing Interval τ (Cmin) (MAD Period Day 10)
Cmin was observed directly from data. It was summarized by dosing regimen and period. 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.
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Lowest Concentration Observed During the Dosing Interval τ (Cmin) (MAD Period Day 10) | 6.273 ng/mL | Geometric Coefficient of Variation 83 |
| PF-06826647 3 mg SAD | Lowest Concentration Observed During the Dosing Interval τ (Cmin) (MAD Period Day 10) | 10.40 ng/mL | Geometric Coefficient of Variation 75 |
| PF-06826647 10 mg SAD | Lowest Concentration Observed During the Dosing Interval τ (Cmin) (MAD Period Day 10) | 55.01 ng/mL | Geometric Coefficient of Variation 65 |
| PF-06826647 30 mg SAD | Lowest Concentration Observed During the Dosing Interval τ (Cmin) (MAD Period Day 10) | 24.77 ng/mL | Geometric Coefficient of Variation 148 |
| PF-06826647 100 mg SAD | Lowest Concentration Observed During the Dosing Interval τ (Cmin) (MAD Period Day 10) | 29.50 ng/mL | Geometric Coefficient of Variation 60 |
| PF-06826647 400 mg SAD | Lowest Concentration Observed During the Dosing Interval τ (Cmin) (MAD Period Day 10) | 62.26 ng/mL | Geometric Coefficient of Variation 112 |
Secondary
Maximum Plasma Concentration (Cmax) (SAD Period)
Cmax was summarized by dosing regimen and period. It was observed directly from data.
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Maximum Plasma Concentration (Cmax) (SAD Period) | 7.844 ng/mL | Geometric Coefficient of Variation 38 |
| PF-06826647 3 mg SAD | Maximum Plasma Concentration (Cmax) (SAD Period) | 47.09 ng/mL | Geometric Coefficient of Variation 35 |
| PF-06826647 10 mg SAD | Maximum Plasma Concentration (Cmax) (SAD Period) | 77.93 ng/mL | Geometric Coefficient of Variation 34 |
| PF-06826647 30 mg SAD | Maximum Plasma Concentration (Cmax) (SAD Period) | 166.8 ng/mL | Geometric Coefficient of Variation 55 |
| PF-06826647 100 mg SAD | Maximum Plasma Concentration (Cmax) (SAD Period) | 404.8 ng/mL | Geometric Coefficient of Variation 62 |
| PF-06826647 400 mg SAD | Maximum Plasma Concentration (Cmax) (SAD Period) | 1218 ng/mL | Geometric Coefficient of Variation 25 |
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.
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Mean Residence Time (MRT) (SAD Period) | 5.596 hours (hr) | Geometric Coefficient of Variation 26 |
| PF-06826647 3 mg SAD | Mean Residence Time (MRT) (SAD Period) | 7.761 hours (hr) | Geometric Coefficient of Variation 30 |
| PF-06826647 10 mg SAD | Mean Residence Time (MRT) (SAD Period) | 16.97 hours (hr) | Geometric Coefficient of Variation 43 |
| PF-06826647 30 mg SAD | Mean Residence Time (MRT) (SAD Period) | 21.23 hours (hr) | Geometric Coefficient of Variation 81 |
| PF-06826647 100 mg SAD | Mean Residence Time (MRT) (SAD Period) | 10.56 hours (hr) | Geometric Coefficient of Variation 36 |
| PF-06826647 400 mg SAD | Mean Residence Time (MRT) (SAD Period) | 9.417 hours (hr) | Geometric Coefficient of Variation 33 |
Secondary
MRT (MAD Period Day 10)
MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from time 0 to infinity.
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24,48,72,96,168 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | MRT (MAD Period Day 10) | 10.56 hours (hr) | Geometric Coefficient of Variation 44 |
| PF-06826647 3 mg SAD | MRT (MAD Period Day 10) | 9.872 hours (hr) | Geometric Coefficient of Variation 33 |
| PF-06826647 10 mg SAD | MRT (MAD Period Day 10) | 17.14 hours (hr) | Geometric Coefficient of Variation 26 |
| PF-06826647 30 mg SAD | MRT (MAD Period Day 10) | 9.622 hours (hr) | Geometric Coefficient of Variation 26 |
| PF-06826647 100 mg SAD | MRT (MAD Period Day 10) | 7.996 hours (hr) | Geometric Coefficient of Variation 19 |
| PF-06826647 400 mg SAD | MRT (MAD Period Day 10) | 9.165 hours (hr) | Geometric Coefficient of Variation 24 |
Secondary
MRT (Psoriasis Cohorts)
MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from time 0 to infinity.
Time frame: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24,168 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | MRT (Psoriasis Cohorts) | 11.27 hours (hr) | Geometric Coefficient of Variation 41 |
| PF-06826647 3 mg SAD | MRT (Psoriasis Cohorts) | 9.444 hours (hr) | Geometric Coefficient of Variation 28 |
Secondary
Observed Accumulation Ratio Based on AUC (Rac) (MAD Period Day 10)
Rac = AUCτ,ss / AUCτ,sd, where ss means 'at steady state' and sd 'single dose'. In this study, Rac = AUCτ(Day 10) / AUCτ(Day 1). Rac was summarized by dosing regimen and period.
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Observed Accumulation Ratio Based on AUC (Rac) (MAD Period Day 10) | 1.085 ratio | Geometric Coefficient of Variation 8 |
| PF-06826647 3 mg SAD | Observed Accumulation Ratio Based on AUC (Rac) (MAD Period Day 10) | 1.082 ratio | Geometric Coefficient of Variation 21 |
| PF-06826647 10 mg SAD | Observed Accumulation Ratio Based on AUC (Rac) (MAD Period Day 10) | 1.328 ratio | Geometric Coefficient of Variation 52 |
| PF-06826647 30 mg SAD | Observed Accumulation Ratio Based on AUC (Rac) (MAD Period Day 10) | 1.225 ratio | Geometric Coefficient of Variation 39 |
| PF-06826647 100 mg SAD | Observed Accumulation Ratio Based on AUC (Rac) (MAD Period Day 10) | 1.191 ratio | Geometric Coefficient of Variation 24 |
| PF-06826647 400 mg SAD | Observed Accumulation Ratio Based on AUC (Rac) (MAD Period Day 10) | 0.8711 ratio | Geometric Coefficient of Variation 30 |
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.
Time frame: Days 1 and 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Observed Accumulation Ratio Based on Cmax (Rac,Cmax) (MAD Period Day 10) | 0.9295 ratio | Geometric Coefficient of Variation 22 |
| PF-06826647 3 mg SAD | Observed Accumulation Ratio Based on Cmax (Rac,Cmax) (MAD Period Day 10) | 0.9852 ratio | Geometric Coefficient of Variation 24 |
| PF-06826647 10 mg SAD | Observed Accumulation Ratio Based on Cmax (Rac,Cmax) (MAD Period Day 10) | 1.282 ratio | Geometric Coefficient of Variation 57 |
| PF-06826647 30 mg SAD | Observed Accumulation Ratio Based on Cmax (Rac,Cmax) (MAD Period Day 10) | 1.139 ratio | Geometric Coefficient of Variation 35 |
| PF-06826647 100 mg SAD | Observed Accumulation Ratio Based on Cmax (Rac,Cmax) (MAD Period Day 10) | 1.275 ratio | Geometric Coefficient of Variation 14 |
| PF-06826647 400 mg SAD | Observed Accumulation Ratio Based on Cmax (Rac,Cmax) (MAD Period Day 10) | 0.9176 ratio | Geometric Coefficient of Variation 25 |
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.
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Peak Trough Ratio (PTR) (MAD Period Day 10) | 13.61 ratio | Geometric Coefficient of Variation 69 |
| PF-06826647 3 mg SAD | Peak Trough Ratio (PTR) (MAD Period Day 10) | 25.31 ratio | Geometric Coefficient of Variation 55 |
| PF-06826647 10 mg SAD | Peak Trough Ratio (PTR) (MAD Period Day 10) | 6.951 ratio | Geometric Coefficient of Variation 23 |
| PF-06826647 30 mg SAD | Peak Trough Ratio (PTR) (MAD Period Day 10) | 26.92 ratio | Geometric Coefficient of Variation 112 |
| PF-06826647 100 mg SAD | Peak Trough Ratio (PTR) (MAD Period Day 10) | 30.09 ratio | Geometric Coefficient of Variation 61 |
| PF-06826647 400 mg SAD | Peak Trough Ratio (PTR) (MAD Period Day 10) | 29.76 ratio | Geometric Coefficient of Variation 97 |
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.
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Percentage of Dose Recovered Unchanged in Urine From Time 0 to the Dosing Interval τ Hours Post-Dose (Aeτ%) (MAD Period Day 10) | 0.7344 Percentage of Dose | Geometric Coefficient of Variation 35 |
| PF-06826647 3 mg SAD | Percentage of Dose Recovered Unchanged in Urine From Time 0 to the Dosing Interval τ Hours Post-Dose (Aeτ%) (MAD Period Day 10) | 1.072 Percentage of Dose | Geometric Coefficient of Variation 65 |
| PF-06826647 10 mg SAD | Percentage of Dose Recovered Unchanged in Urine From Time 0 to the Dosing Interval τ Hours Post-Dose (Aeτ%) (MAD Period Day 10) | 1.280 Percentage of Dose | Geometric Coefficient of Variation 66 |
| PF-06826647 30 mg SAD | Percentage of Dose Recovered Unchanged in Urine From Time 0 to the Dosing Interval τ Hours Post-Dose (Aeτ%) (MAD Period Day 10) | 0.7827 Percentage of Dose | Geometric Coefficient of Variation 75 |
| PF-06826647 100 mg SAD | Percentage of Dose Recovered Unchanged in Urine From Time 0 to the Dosing Interval τ Hours Post-Dose (Aeτ%) (MAD Period Day 10) | 0.7333 Percentage of Dose | Geometric Coefficient of Variation 624 |
| PF-06826647 400 mg SAD | Percentage of Dose Recovered Unchanged in Urine From Time 0 to the Dosing Interval τ Hours Post-Dose (Aeτ%) (MAD Period Day 10) | 1.228 Percentage of Dose | Geometric Coefficient of Variation 92 |
Secondary
PTR (Psoriasis Cohorts)
PTR = Cmax,ss / Cmin,ss, it was summarized by dosing regimen and period.
Time frame: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | PTR (Psoriasis Cohorts) | 13.52 ratio | Geometric Coefficient of Variation 76 |
| PF-06826647 3 mg SAD | PTR (Psoriasis Cohorts) | 22.81 ratio | Geometric Coefficient of Variation 171 |
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.
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Renal Clearance (Clr) (MAD Period Day 10) | 0.2928 L/hr | Geometric Coefficient of Variation 70 |
| PF-06826647 3 mg SAD | Renal Clearance (Clr) (MAD Period Day 10) | 0.5500 L/hr | Geometric Coefficient of Variation 42 |
| PF-06826647 10 mg SAD | Renal Clearance (Clr) (MAD Period Day 10) | 1.274 L/hr | Geometric Coefficient of Variation 39 |
| PF-06826647 30 mg SAD | Renal Clearance (Clr) (MAD Period Day 10) | 0.5777 L/hr | Geometric Coefficient of Variation 34 |
| PF-06826647 100 mg SAD | Renal Clearance (Clr) (MAD Period Day 10) | 0.4076 L/hr | Geometric Coefficient of Variation 500 |
| PF-06826647 400 mg SAD | Renal Clearance (Clr) (MAD Period Day 10) | 0.9909 L/hr | Geometric Coefficient of Variation 58 |
Secondary
Secondary: Dose Normalized AUCinf (AUCinf[dn]) (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). 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.
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Secondary: Dose Normalized AUCinf (AUCinf[dn]) (SAD Period) | 15.86 ng*hr/mL/mg | Geometric Coefficient of Variation 59 |
| PF-06826647 3 mg SAD | Secondary: Dose Normalized AUCinf (AUCinf[dn]) (SAD Period) | 36.93 ng*hr/mL/mg | Geometric Coefficient of Variation 67 |
| PF-06826647 10 mg SAD | Secondary: Dose Normalized AUCinf (AUCinf[dn]) (SAD Period) | 28.28 ng*hr/mL/mg | Geometric Coefficient of Variation 41 |
| PF-06826647 30 mg SAD | Secondary: Dose Normalized AUCinf (AUCinf[dn]) (SAD Period) | 15.82 ng*hr/mL/mg | Geometric Coefficient of Variation 42 |
| PF-06826647 100 mg SAD | Secondary: Dose Normalized AUCinf (AUCinf[dn]) (SAD Period) | 7.636 ng*hr/mL/mg | Geometric Coefficient of Variation 65 |
| PF-06826647 400 mg SAD | Secondary: Dose Normalized AUCinf (AUCinf[dn]) (SAD Period) | 7.370 ng*hr/mL/mg | Geometric Coefficient of Variation 25 |
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.
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24,48,72,96,168 hours post-dose
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Terminal Elimination Half-Life ((t½) (MAD Period Day 10) | 8.802 hours (hr) | Standard Deviation 5.8142 |
| PF-06826647 3 mg SAD | Terminal Elimination Half-Life ((t½) (MAD Period Day 10) | 12.72 hours (hr) | Standard Deviation 12.644 |
| PF-06826647 10 mg SAD | Terminal Elimination Half-Life ((t½) (MAD Period Day 10) | 26.93 hours (hr) | Standard Deviation 8.1132 |
| PF-06826647 30 mg SAD | Terminal Elimination Half-Life ((t½) (MAD Period Day 10) | 7.500 hours (hr) | Standard Deviation 2.5803 |
| PF-06826647 100 mg SAD | Terminal Elimination Half-Life ((t½) (MAD Period Day 10) | 7.433 hours (hr) | Standard Deviation 4.7975 |
| PF-06826647 400 mg SAD | Terminal Elimination Half-Life ((t½) (MAD Period Day 10) | 34.33 hours (hr) | Standard Deviation 21.926 |
Secondary
Terminal Elimination Half-Life ((t½) (Psoriasis Cohorts)
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.
Time frame: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24,168 hours post-dose
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Terminal Elimination Half-Life ((t½) (Psoriasis Cohorts) | 7.796 hours (hr) | Standard Deviation 5.7087 |
| PF-06826647 3 mg SAD | Terminal Elimination Half-Life ((t½) (Psoriasis Cohorts) | 6.809 hours (hr) | Standard Deviation 5.405 |
Secondary
Terminal Elimination Half-Life ((t½) (SAD Period)
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.
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Terminal Elimination Half-Life ((t½) (SAD Period) | 3.620 hours (hr) | Standard Deviation 1.2956 |
| PF-06826647 3 mg SAD | Terminal Elimination Half-Life ((t½) (SAD Period) | 6.032 hours (hr) | Standard Deviation 1.905 |
| PF-06826647 10 mg SAD | Terminal Elimination Half-Life ((t½) (SAD Period) | 19.69 hours (hr) | Standard Deviation 9.5144 |
| PF-06826647 30 mg SAD | Terminal Elimination Half-Life ((t½) (SAD Period) | 38.77 hours (hr) | Standard Deviation 35.966 |
| PF-06826647 100 mg SAD | Terminal Elimination Half-Life ((t½) (SAD Period) | 16.25 hours (hr) | Standard Deviation 9.343 |
| PF-06826647 400 mg SAD | Terminal Elimination Half-Life ((t½) (SAD Period) | 22.21 hours (hr) | Standard Deviation 24.586 |
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.
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PBO SAD | Time for Cmax (Tmax) (SAD Period) | 2.00 hours (hr) |
| PF-06826647 3 mg SAD | Time for Cmax (Tmax) (SAD Period) | 2.00 hours (hr) |
| PF-06826647 10 mg SAD | Time for Cmax (Tmax) (SAD Period) | 2.00 hours (hr) |
| PF-06826647 30 mg SAD | Time for Cmax (Tmax) (SAD Period) | 2.00 hours (hr) |
| PF-06826647 100 mg SAD | Time for Cmax (Tmax) (SAD Period) | 2.00 hours (hr) |
| PF-06826647 400 mg SAD | Time for Cmax (Tmax) (SAD Period) | 2.00 hours (hr) |
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.
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PBO SAD | Tmax (MAD Period Day 1) | 3.00 hours (hr) |
| PF-06826647 3 mg SAD | Tmax (MAD Period Day 1) | 4.00 hours (hr) |
| PF-06826647 10 mg SAD | Tmax (MAD Period Day 1) | 4.00 hours (hr) |
| PF-06826647 30 mg SAD | Tmax (MAD Period Day 1) | 3.00 hours (hr) |
| PF-06826647 100 mg SAD | Tmax (MAD Period Day 1) | 4.00 hours (hr) |
| PF-06826647 400 mg SAD | Tmax (MAD Period Day 1) | 2.00 hours (hr) |
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.
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PBO SAD | Tmax (MAD Period Day 10) | 4.00 hours (hr) |
| PF-06826647 3 mg SAD | Tmax (MAD Period Day 10) | 4.00 hours (hr) |
| PF-06826647 10 mg SAD | Tmax (MAD Period Day 10) | 4.00 hours (hr) |
| PF-06826647 30 mg SAD | Tmax (MAD Period Day 10) | 4.00 hours (hr) |
| PF-06826647 100 mg SAD | Tmax (MAD Period Day 10) | 4.00 hours (hr) |
| PF-06826647 400 mg SAD | Tmax (MAD Period Day 10) | 4.00 hours (hr) |
Secondary
Tmax (Psoriasis Cohorts)
Tmax was summarized by dosing regimen and period. It was observed directly from data as time of first occurrence.
Time frame: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PBO SAD | Tmax (Psoriasis Cohorts) | 4.00 hours (hr) |
| PF-06826647 3 mg SAD | Tmax (Psoriasis Cohorts) | 4.00 hours (hr) |
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.
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Vz/F (MAD Period Day 10) | 433.5 liters (L) | Geometric Coefficient of Variation 52 |
| PF-06826647 3 mg SAD | Vz/F (MAD Period Day 10) | 643.6 liters (L) | Geometric Coefficient of Variation 98 |
| PF-06826647 10 mg SAD | Vz/F (MAD Period Day 10) | 3224 liters (L) | Geometric Coefficient of Variation 90 |
| PF-06826647 30 mg SAD | Vz/F (MAD Period Day 10) | 758.9 liters (L) | Geometric Coefficient of Variation 93 |
| PF-06826647 100 mg SAD | Vz/F (MAD Period Day 10) | 519.2 liters (L) | Geometric Coefficient of Variation 67 |
| PF-06826647 400 mg SAD | Vz/F (MAD Period Day 10) | 2944 liters (L) | Geometric Coefficient of Variation 166 |
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.
Time frame: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PBO SAD | Vz/F (Psoriasis Cohorts) | 408.1 liters (L) | Geometric Coefficient of Variation 30 |
| PF-06826647 3 mg SAD | Vz/F (Psoriasis Cohorts) | 461.2 liters (L) | Geometric Coefficient of Variation 54 |