Plaque Psoriasis
Conditions
Brief summary
The main purpose of the study is to determine if PF-06700841 is safe and well tolerated when administered to humans. A secondary purpose is to assess what the body does to PF-06700841 and to assess what PF-06700841 does to the body when given as single and multiple doses. The pharmacokinetic properties of different forms of PF-06700841 may be studied (tablet and solution/suspension forms).
Interventions
DRUGPF-06700841 oral solution/suspension
Oral solution or suspension of study drug PF-06700841 (once daily or twice daily during multiple dosing periods)
OTHERPlacebo
Matching placebo given during the single ascending and multiple dose periods
DRUGPF-06700841 tablet
PF-06700841 tablet formulation administered during the bioavailability / food effect investigation
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria for Healthy Subject Cohorts: * Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive * No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) Key Inclusion Criteria for Psoriasis Subject Cohorts: * Male subjects and/or female subjects of non-childbearing potential with a diagnosis of plaque psoriasis who are between the ages of 18 and 65 years, inclusive * Have a diagnosis of plaque psoriasis for at least 6 months prior to first study dose
Exclusion criteria
Key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 | Baseline, 24 hours post-dose on Day 1 | — |
| Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 | Baseline, 16 hours post-dose on Day 10 | — |
| Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Blood Pressure at Day 28 | Baseline, 16 hours post-dose on Day 28 | — |
| Single Ascending Dose (SAD) Cohort: Change From Baseline in Pulse Rate at Day 1 | Baseline, 24 hours post-dose on Day 1 | — |
| Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Pulse Rate at Day 10 | Baseline, 16 hours post-dose on Day 10 | — |
| Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Pulse Rate at Day 28 | Baseline, 16 hours post-dose on Day 28 | — |
| Single Ascending Dose (SAD) Cohort: Change From Baseline in Oral Temperature at Day 1 | Baseline, 24 hours post-dose on Day 1 | — |
| Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Oral Temperature at Day 10 | Baseline, 16 hours post-dose on Day 10 | — |
| Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Oral Temperature at Day 28 | Baseline, 16 hours post-dose on Day 28 | — |
| Number of Participants With Change From Baseline in Physical Examinations | SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37 | Physical examinations included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. |
| Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | Baseline, 24 hours post-dose on Day 1 | — |
| Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | Baseline, 16 hours post-dose on Day 10 | — |
| Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28 | Baseline, 16 hours post-dose on Day 28 | — |
| Single Ascending Dose (SAD) Cohort: Change From Baseline in Heart Rate at Day 1 | Baseline, 24 hours post-dose on Day 1 | — |
| Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Heart Rate at Day 10 | Baseline, 16 hours post-dose on Day 10 | — |
| Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Heart Rate at Day 28 | Baseline, 16 hours post-dose on Day 28 | — |
| Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug up to the end of study (up to Day 8 in SAD cohort, Day 28 in MAD cohort, Day 56 in MAD Psoriasis cohort, Day 37 in Food effect cohort), that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAE and non-SAE. |
| Number of Adverse Events (AEs) According to Severity | SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37 | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function. |
| Number of Participants With Laboratory Abnormalities | SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37 | Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count: less than(\<) 0.8\*lower limit of normal (LLN); mean corpuscular volume; mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration: \<0.9\*LLN,\>1.1\*upper limit of normal (ULN); platelets: \<0.5\*LLN,\>1.75\*ULN, white blood cell count: \<0.6\*LLN, \>1.5\*ULN; lymphocytes, total neutrophils: \<0.8\*LLN, \>1.2\*ULN; eosinophils, basophils, monocytes: \>1.2\*ULN; coagulation: activated partial thromboplastin time, prothrombin, prothrombin international ratio: \>1.1\*ULN; liver function: bilirubin: \>1.5\*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: \>3.0\*ULN; protein, albumin: \<0.8\*LLN\>\</0\>1.2\*ULN; renal function:blood urea nitrogen,creatinine: \>1.3\*ULN; uric acid: \>1.2\*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: \<0.9\*LLN,\>1.1\*ULN; urinalysis: pH\<4.5, \>8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: \<0.6\*LLN,\>1.5\*ULN) |
| Single Ascending Dose (SAD) Cohort: Change From Baseline in Creatinine Clearance at Day 1 | Baseline, 24 hours post-dose on Day 1 | Creatinine clearance is a measure of kidney function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. |
| Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 10 | Baseline, 16 hours post-dose on Day 10 | Creatinine clearance is a measure of kidney function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. |
| Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 28 | Baseline, 16 hours post-dose on Day 28 | Creatinine clearance is a measure of kidney function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. |
| Food Effect Cohort: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06700841 | Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1 | AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). |
| Food Effect Cohort: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06700841 | pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1 | Area under the plasma concentration time-curve from time zero to the time of last measured concentration (AUClast). |
| Food Effect Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841 | pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Baseline, Day 4, 8, 10, 11, 14, 28 | — |
| Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Baseline, Day 4, 6 ,8,10, 13, 14, 21, 28, 35, 42, 56 | — |
| Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841 | SAD: pre-dose, 0.5,1,2,4,6,8,12,16,24,36,48,72,96 hour post dose on Day 1; MAD: pre-dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5,1,2,4,6,8,12,16,24 hours post dose on Day 28 | — |
| Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Baseline, Day 4, 8, 10, 11, 14, 28 | — |
| Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Baseline, Day 4, 6 ,8,10, 13, 14, 21, 28, 35, 42, 56 | — |
| Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8 | Baseline, Day 2, 5, 8 | — |
| Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06700841 | SAD: pre-dose, 0.5,1,2,4,6,8,12,16,24,36,48,72,96 hour post dose on Day 1; MAD: pre-dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5,1,2,4,6,8,12,16,24 hours post dose on Day 28 | — |
| Food Effect Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF--06700841 | Pre--dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1 | — |
| Single Ascending Dose (SAD) Cohort: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06700841 | pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1 | AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). |
| Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06700841 | MAD: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5,1,2,4,6,8,12,16,24 hours post dose on Day 28 | Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort and 24 hours for MAD Psoriasis cohort. |
| Single Ascending Dose (SAD) Cohort: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06700841 | pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1 | Area under the plasma concentration time-curve from time zero to the time of last measured concentration (AUClast). |
| Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06700841 | SAD: pre-dose, 0.5,1,2,4,6,8,12,16,24,36,48,72,96 hour post dose on Day 1; MAD: pre-dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5,1,2,4,6,8,12,16,24 hours post dose on Day 28 | Dose normalized (dn) Cmax was calculated by dividing Cmax by the exact dose of PF 06700841 (in mg) administered to a participant. |
| Single Ascending Dose (SAD) Cohort: Dose Normalized Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf[dn]) of PF-06700841 | pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1 | AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUCinf(dn) was calculated by dividing AUCinf by the exact dose of PF-06700841 (in mg) administered to a participant. |
| Single Ascending Dose (SAD) Cohort: Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) of PF-06700841 | Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1 | Area under the plasma concentration time-curve from time zero to the time of last measured concentration (AUClast). AUClast(dn) was calculated by dividing AUClast by the exact dose of of PF-06700841 (in mg) administered to a participant. |
| Multiple Ascending Dose (MAD) Cohort: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau[dn]) of PF-06700841 | pre-dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10 | Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort. AUCtau(dn) was calculated by dividing AUCtau by the exact dose of of PF-06700841 (in mg) administered to a participant. |
| Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Plasma Decay Half-Life (t1/2) of PF-06700841 | SAD: pre--dose, 0.5,1,2,4,6,8,12,16,24,36,48,72,96 hour post-dose on Day 1; MAD: pre--dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10; MAD Psoriasis: pre--dose, 0.5,1,2,4,6,8,12,16,24 hours post-dose on Day 28 | Plasma decay half-life is the time measured for the plasma concentration of PF-06700841 to decrease by one half. |
| Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Mean Residence Time (MRT) of PF-06700841 | SAD: pre--dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post-dose on Day 1; MAD: pre--dose 0.5, 1, 2, 4, 6, 8, 12, 24 hour post--dose on Day 10; MAD Psoriasis: pre--dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose on Day 28 | MRT= AUMCinf/AUCinf, where AUMCinf is the area under the first moment curve from time 0 extrapolated to infinite time, calculated using the linear/log trapezoidal method. |
| Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Volume of Distribution (Vz/F) of PF-06700841 | SAD: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post-dose on Day 1; MAD: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose on Day 28 | Volume of distribution 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. |
| Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Clearance (CL/F) of PF-06700841 | SAD: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post-dose on Day 1; MAD: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose on Day 28 | Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Clearance obtained after oral dose is influenced by the fraction of the dose absorbed. CL/F =Dose of PF-06700841/AUCinf. |
| Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Peak-Trough Fluctuation (PTF) of PF-06700841 | MAD: pre--dose 0.5, 1, 2, 4, 6, 8, 12, 24 hour post--dose on Day 10; MAD Psoriasis: pre--dose, 0.5,1,2,4,6,8,12,16,24 hours post-dose on Day 28 | PTF was calculated as: Cmax-Cmin/Cavg. Cmax is the maximum observed plasma concentration of PF-06700841. Cmin is the minimum observed plasma concentration of PF-06700841. Cavg is the average observed plasma concentration of PF-06700841 calculated as area under the plasma concentration-time curve during a dosing Interval (AUC\[tau\]) divided by the dosing interval (tau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort and 24 hours for MAD Psoriasis cohort. |
| Multiple Ascending Dose (MAD) Cohort: Amount of PF-06700841 Recovered Unchanged in the Urine Over the Time Interval Tau (Aetau) | 0-24 hour on Day 10 | Aetau is the amount of drug recovered unchanged in urine during the dosing interval (tau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort. |
| Multiple Ascending Dose (MAD) Cohort: Percentage of Dose of PF-06700841 Recovered Unchanged in the Urine Over the Time Interval Tau (Aetau%) | 0-24 hours on Day 10 | Aetau% was calculated as: 100\*Aetau/dose. Aetau is the amount of drug recovered unchanged in urine during the dosing interval (tau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort. |
| Multiple Ascending Dose (MAD) Cohort: Renal Clearance | 0-24 hours on Day 10 | Renal clearance was calculated as amount of drug recovered unchanged in urine during the dosing interval tau (Aetau) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort. |
| Single Ascending Dose (SAD) Cohort: Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Baseline | Baseline | Serum samples for IP-10 were analyzed using a validated analytical assay. Lower limit of quantification (LLOQ) for IP-10 was 10 pg/mL. |
| Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Baseline, Day 2, 5, 10, 11, 28 | Serum samples for IP-10 were analyzed using a validated analytical assay. LLOQ for IP-10 was 10 pg/mL. |
| Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Baseline, Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Serum samples for IP-10 were analyzed using a validated analytical assay. Lower limit of quantification (LLOQ) for IP-10 was 10 pg/mL. |
| Single Ascending Dose (SAD) Cohort: High Sensitivity C-reactive Protein (hsCRP) Concentration in Serum at Baseline | Baseline | Serum samples for hsCRP were analyzed using a validated analytical assay. Reference range for measurement of CRP was 0.015 to 2.0 mg/dL. LLOQ for hsCRP was 0.03 mg/dL and limit of detection was 0.015 mg/dL. |
| Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Baseline, Day 2, 5, 10, 11, 28 | Serum samples for hsCRP were analyzed using a validated analytical assay. Reference range for measurement of CRP was 0.015 to 2.0 mg/dL. LLOQ for hsCRP was 0.03 mg/dL and limit of detection was 0.015 mg/dL. |
| Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Baseline, Day 2, 5 ,7,14, 21, 28, 29, 35, 56 | Serum samples for hsCRP were analyzed using a validated analytical assay. Reference range for measurement of CRP was 0.015 to 2.0 mg/dL. LLOQ for hsCRP was 0.03 mg/dL and limit of detection was 0.015 mg/dL. |
| Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8 | Baseline, Day 2, 5, 8 | — |
Countries
United States
Participant flow
Pre-assignment details
Study conducted in 7 Healthy Participant (HP) cohorts: 6 cohorts included Single Ascending Dose (SAD), 4 which continued into Multiple Ascending Dose (MAD) with washout, and a final cohort was tested for food effect (fasted/fed) with washout. 1 multiple dose (MD) cohort in Psoriasis subjects received drug at 2 different dose levels or placebo.
Participants by arm
| Arm | Count |
|---|---|
| PF--06700841: 1 Milligram (mg) SAD Cohort Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days. | 7 |
| PF--06700841: 3 mg SAD Cohort Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days. | 6 |
| PF--06700841: 10 mg SAD Cohort Then MAD Cohort Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 10 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days). | 6 |
| PF-06700841: 30 mg SAD Cohort Then MAD Cohort Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 30 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days). | 6 |
| PF--06700841: 100 mg SAD, 100 mg MAD, 50 mg MAD Cohort Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 100 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days) followed by washout period of at least 7 days, then PF-06700841 tablet 50 mg orally, twice daily from Day 1 to Day 10 in the treatment period 3 for MAD cohort (28 days). | 8 |
| PF--06700841: 200 mg SAD Cohort, 175 mg MAD Cohort Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 175 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days). | 8 |
| Placebo: SAD Cohort Then MAD Cohort Healthy participants received placebo matched to PF-06700841 single tablet orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then placebo matched to PF-06700841 tablet once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days) followed by washout period of at least 7 days followed by placebo matched to PF-06700841 tablet twice daily from Day 1 to Day 10 in the treatment period 3 for MAD cohort (28 days). | 13 |
| Placebo: MAD Psoriasis Cohort Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days. | 9 |
| PF-06700841: 30 mg MAD Psoriasis Cohort Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days. | 14 |
| PF-06700841: 100 mg MAD Psoriasis Cohort Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days. | 7 |
| PF-06700841: 100 mg Food Effect Cohort All participants who received either PF-06700841 100 mg tablet under fasted condition or PF-06700841 100 mg tablet under fed condition or PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in any 1 of the 6 treatment sequences in food effects cohort of the study. | 12 |
| Total | 96 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| HP MAD, Psoriasis MD, HP Fasted/Fed | Adverse Event | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 0 | 6 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| HP MAD, Psoriasis MD, HP Fasted/Fed | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| HP MAD, Psoriasis MD, HP Fasted/Fed | Non-Compliance | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| HP MAD, Psoriasis MD, HP Fasted/Fed | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| HP Period 1 | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| HP Period 1 | Withdrawal by Subject | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| HP Washout 1 | Lost to Follow-up | 0 | 0 | 1 | 1 | 2 | 2 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| HP Washout 2 | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 | 0 | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | PF-06700841: 100 mg Food Effect Cohort | Total | PF--06700841: 1 Milligram (mg) SAD Cohort | PF--06700841: 3 mg SAD Cohort | PF--06700841: 10 mg SAD Cohort Then MAD Cohort | PF-06700841: 30 mg SAD Cohort Then MAD Cohort | PF--06700841: 100 mg SAD, 100 mg MAD, 50 mg MAD Cohort | PF--06700841: 200 mg SAD Cohort, 175 mg MAD Cohort | Placebo: SAD Cohort Then MAD Cohort | Placebo: MAD Psoriasis Cohort | PF-06700841: 30 mg MAD Psoriasis Cohort | PF-06700841: 100 mg MAD Psoriasis Cohort |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized 18-44 Years | 5 participants | 55 participants | 4 participants | 2 participants | 1 participants | 4 participants | 5 participants | 6 participants | 11 participants | 6 participants | 6 participants | 5 participants |
| Age, Customized 45-64 Years | 7 participants | 41 participants | 3 participants | 4 participants | 5 participants | 2 participants | 3 participants | 2 participants | 2 participants | 3 participants | 8 participants | 2 participants |
| Gender Female | 1 Participants | 6 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants |
| Gender Male | 11 Participants | 90 Participants | 7 Participants | 6 Participants | 6 Participants | 6 Participants | 8 Participants | 7 Participants | 12 Participants | 8 Participants | 12 Participants | 7 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 | EG018 affected / at risk | EG019 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 13 | 0 / 9 | 1 / 2 | 5 / 9 | 1 / 7 | 1 / 6 | 0 / 6 | 3 / 5 | 1 / 6 | 2 / 4 | 3 / 8 | 3 / 6 | 5 / 5 | 2 / 8 | 5 / 6 | 11 / 14 | 6 / 7 | 1 / 12 | 2 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 13 | 0 / 9 | 0 / 2 | 0 / 9 | 0 / 7 | 0 / 6 | 0 / 6 | 0 / 5 | 0 / 6 | 0 / 4 | 0 / 8 | 0 / 6 | 0 / 5 | 0 / 8 | 0 / 6 | 0 / 14 | 0 / 7 | 0 / 12 | 0 / 12 | 0 / 12 |
Outcome results
Primary
Food Effect Cohort: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06700841
Area under the plasma concentration time-curve from time zero to the time of last measured concentration (AUClast).
Time frame: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1
Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo: SAD Cohort | Food Effect Cohort: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06700841 | 6447 ng*hr/mL | Geometric Coefficient of Variation 46 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Food Effect Cohort: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06700841 | 6694 ng*hr/mL | Geometric Coefficient of Variation 43 |
| PF--06700841: 3 mg SAD Cohort | Food Effect Cohort: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06700841 | 5305 ng*hr/mL | Geometric Coefficient of Variation 53 |
Primary
Food Effect Cohort: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06700841
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1
Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo: SAD Cohort | Food Effect Cohort: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06700841 | 6463 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 46 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Food Effect Cohort: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06700841 | 6720 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 43 |
| PF--06700841: 3 mg SAD Cohort | Food Effect Cohort: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06700841 | 5321 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 53 |
Primary
Food Effect Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841
Time frame: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1
Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest in at least 1 treatment period.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo: SAD Cohort | Food Effect Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841 | 1022 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 35 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Food Effect Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841 | 1084 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 40 |
| PF--06700841: 3 mg SAD Cohort | Food Effect Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841 | 656.6 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 26 |
Primary
Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 10
Creatinine clearance is a measure of kidney function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time.
Time frame: Baseline, 16 hours post-dose on Day 10
Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 10 | Baseline (n =9, 2, 5, 4, 6, 5, 6, 2, 2, 7) | 114.4 mL/min | Standard Deviation 27.75 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 10 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4, 2, 2, 7) | 0.7 mL/min | Standard Deviation 33.29 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 10 | Baseline (n =9, 2, 5, 4, 6, 5, 6, 2, 2, 7) | 111.0 mL/min | Standard Deviation 1.41 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 10 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4, 2, 2, 7) | -2.5 mL/min | Standard Deviation 57.28 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 10 | Baseline (n =9, 2, 5, 4, 6, 5, 6, 2, 2, 7) | 112.6 mL/min | Standard Deviation 42.08 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 10 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4, 2, 2, 7) | 26.8 mL/min | Standard Deviation 46.9 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 10 | Baseline (n =9, 2, 5, 4, 6, 5, 6, 2, 2, 7) | 115.0 mL/min | Standard Deviation 34.13 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 10 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4, 2, 2, 7) | -19.0 mL/min | Standard Deviation 25.51 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 10 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4, 2, 2, 7) | -47.0 mL/min | Standard Deviation 55.68 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 10 | Baseline (n =9, 2, 5, 4, 6, 5, 6, 2, 2, 7) | 142.5 mL/min | Standard Deviation 56.68 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 10 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4, 2, 2, 7) | -39.5 mL/min | Standard Deviation 29.86 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 10 | Baseline (n =9, 2, 5, 4, 6, 5, 6, 2, 2, 7) | 138.4 mL/min | Standard Deviation 51.27 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 10 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4, 2, 2, 7) | 3.5 mL/min | Standard Deviation 40.42 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 10 | Baseline (n =9, 2, 5, 4, 6, 5, 6, 2, 2, 7) | 83.0 mL/min | Standard Deviation 39.73 |
| Placebo: Once Daily MAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 10 | Baseline (n =9, 2, 5, 4, 6, 5, 6, 2, 2, 7) | 140.5 mL/min | Standard Deviation 55.86 |
| Placebo: Once Daily MAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 10 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4, 2, 2, 7) | -38.5 mL/min | Standard Deviation 60.1 |
| Placebo: Twice Daily MAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 10 | Baseline (n =9, 2, 5, 4, 6, 5, 6, 2, 2, 7) | 158.0 mL/min | Standard Deviation 36.77 |
| Placebo: Twice Daily MAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 10 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4, 2, 2, 7) | -50.0 mL/min | Standard Deviation 4.24 |
| PF-06700841: 10 mg Once Daily MAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 10 | Baseline (n =9, 2, 5, 4, 6, 5, 6, 2, 2, 7) | 172.4 mL/min | Standard Deviation 51.74 |
| PF-06700841: 10 mg Once Daily MAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 10 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4, 2, 2, 7) | -67.3 mL/min | Standard Deviation 61.45 |
Primary
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10
Time frame: Baseline, 16 hours post-dose on Day 10
Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time point for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QRS Complex: Baseline (n =9,2,5,4,6,5,6) | 96.6 msec | Standard Deviation 5.83 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | PR Interval: Change at Day 10 (n =9,2,5,3,6,4,4) | 5.2 msec | Standard Deviation 3.59 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | PR Interval: Baseline (n =9,2,5,4,6,5,6) | 176.9 msec | Standard Deviation 16.31 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QRS Complex: Change at Day 10 (n =9,2,5,3,6,4,4) | 0.9 msec | Standard Deviation 1.6 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QT Interval: Baseline (n =9,2,5,4,6,5,6) | 411.9 msec | Standard Deviation 27.98 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QT Interval: Change at Day 10 (n =9,2,5,3,6,4,4) | -3.9 msec | Standard Deviation 14.72 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QTC Interval: Baseline (n =9,2,5,4,6,5,6) | 398.7 msec | Standard Deviation 11.35 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QTC Interval: Change at Day 10 (n =9,2,5,3,6,4,4) | -0.3 msec | Standard Deviation 9.82 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | PR Interval: Change at Day 10 (n =9,2,5,3,6,4,4) | 4.7 msec | Standard Deviation 6.6 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QTC Interval: Change at Day 10 (n =9,2,5,3,6,4,4) | -1.5 msec | Standard Deviation 10.14 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QRS Complex: Baseline (n =9,2,5,4,6,5,6) | 96.0 msec | Standard Deviation 7.07 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QRS Complex: Change at Day 10 (n =9,2,5,3,6,4,4) | -0.5 msec | Standard Deviation 6.36 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QT Interval: Baseline (n =9,2,5,4,6,5,6) | 425.5 msec | Standard Deviation 10.61 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QT Interval: Change at Day 10 (n =9,2,5,3,6,4,4) | 1.0 msec | Standard Deviation 11.79 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QTC Interval: Baseline (n =9,2,5,4,6,5,6) | 415.5 msec | Standard Deviation 4.95 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | PR Interval: Baseline (n =9,2,5,4,6,5,6) | 180.0 msec | Standard Deviation 1.41 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QRS Complex: Baseline (n =9,2,5,4,6,5,6) | 103.0 msec | Standard Deviation 9.14 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QTC Interval: Change at Day 10 (n =9,2,5,3,6,4,4) | -2.9 msec | Standard Deviation 3 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QRS Complex: Change at Day 10 (n =9,2,5,3,6,4,4) | -3.2 msec | Standard Deviation 9.49 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QT Interval: Baseline (n =9,2,5,4,6,5,6) | 407.4 msec | Standard Deviation 18.17 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QT Interval: Change at Day 10 (n =9,2,5,3,6,4,4) | -1.0 msec | Standard Deviation 23.42 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QTC Interval: Baseline (n =9,2,5,4,6,5,6) | 396.4 msec | Standard Deviation 15.53 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | PR Interval: Change at Day 10 (n =9,2,5,3,6,4,4) | 7.7 msec | Standard Deviation 5.36 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | PR Interval: Baseline (n =9,2,5,4,6,5,6) | 167.6 msec | Standard Deviation 10.69 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QRS Complex: Change at Day 10 (n =9,2,5,3,6,4,4) | -2.3 msec | Standard Deviation 6.17 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QTC Interval: Change at Day 10 (n =9,2,5,3,6,4,4) | -5.0 msec | Standard Deviation 10.49 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QT Interval: Baseline (n =9,2,5,4,6,5,6) | 398.0 msec | Standard Deviation 9.56 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QT Interval: Change at Day 10 (n =9,2,5,3,6,4,4) | 2.6 msec | Standard Deviation 9.26 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QTC Interval: Baseline (n =9,2,5,4,6,5,6) | 401.5 msec | Standard Deviation 15.37 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QRS Complex: Baseline (n =9,2,5,4,6,5,6) | 101.0 msec | Standard Deviation 20.05 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | PR Interval: Baseline (n =9,2,5,4,6,5,6) | 169.0 msec | Standard Deviation 22.38 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | PR Interval: Change at Day 10 (n =9,2,5,3,6,4,4) | 14.3 msec | Standard Deviation 8.41 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QT Interval: Baseline (n =9,2,5,4,6,5,6) | 399.7 msec | Standard Deviation 16.12 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QTC Interval: Change at Day 10 (n =9,2,5,3,6,4,4) | -1.3 msec | Standard Deviation 10.34 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QT Interval: Change at Day 10 (n =9,2,5,3,6,4,4) | 1.3 msec | Standard Deviation 16.66 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QTC Interval: Baseline (n =9,2,5,4,6,5,6) | 396.0 msec | Standard Deviation 6.54 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QRS Complex: Change at Day 10 (n =9,2,5,3,6,4,4) | 1.3 msec | Standard Deviation 5.32 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | PR Interval: Baseline (n =9,2,5,4,6,5,6) | 168.5 msec | Standard Deviation 18.79 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | PR Interval: Change at Day 10 (n =9,2,5,3,6,4,4) | 7.3 msec | Standard Deviation 10.07 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QRS Complex: Baseline (n =9,2,5,4,6,5,6) | 102.7 msec | Standard Deviation 8.52 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QT Interval: Change at Day 10 (n =9,2,5,3,6,4,4) | 2.3 msec | Standard Deviation 5.51 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QTC Interval: Change at Day 10 (n =9,2,5,3,6,4,4) | -0.3 msec | Standard Deviation 4.46 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QTC Interval: Baseline (n =9,2,5,4,6,5,6) | 403.2 msec | Standard Deviation 6.26 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QT Interval: Baseline (n =9,2,5,4,6,5,6) | 397.0 msec | Standard Deviation 23.29 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | PR Interval: Baseline (n =9,2,5,4,6,5,6) | 171.6 msec | Standard Deviation 14.77 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | PR Interval: Change at Day 10 (n =9,2,5,3,6,4,4) | 11.2 msec | Standard Deviation 5.14 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QRS Complex: Baseline (n =9,2,5,4,6,5,6) | 103.0 msec | Standard Deviation 8.34 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QRS Complex: Change at Day 10 (n =9,2,5,3,6,4,4) | 2.9 msec | Standard Deviation 5.26 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QTC Interval: Baseline (n =9,2,5,4,6,5,6) | 403.5 msec | Standard Deviation 11.96 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QT Interval: Change at Day 10 (n =9,2,5,3,6,4,4) | 2.1 msec | Standard Deviation 23.19 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QTC Interval: Change at Day 10 (n =9,2,5,3,6,4,4) | 2.0 msec | Standard Deviation 10.47 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | PR Interval: Baseline (n =9,2,5,4,6,5,6) | 168.0 msec | Standard Deviation 6.66 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | PR Interval: Change at Day 10 (n =9,2,5,3,6,4,4) | 1.4 msec | Standard Deviation 2.33 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QRS Complex: Baseline (n =9,2,5,4,6,5,6) | 95.2 msec | Standard Deviation 8.7 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QRS Complex: Change at Day 10 (n =9,2,5,3,6,4,4) | -1.7 msec | Standard Deviation 1.83 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 10 | QT Interval: Baseline (n =9,2,5,4,6,5,6) | 401.8 msec | Standard Deviation 27.66 |
Primary
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10
Time frame: Baseline, 16 hours post-dose on Day 10
Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 | Supine SBP: Baseline (n=9,2,5,4,6,5,6) | 112.2 mmHg | Standard Deviation 9.78 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 | Supine SBP: Change at Day 10 (n=9,2,5,3,6,4,4) | 4.0 mmHg | Standard Deviation 9.12 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 | Supine DBP: Baseline (n=9,2,5,4,6,5,6) | 60.3 mmHg | Standard Deviation 4.15 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 | Supine DBP: Change at Day 10 (n=9,2,5,3,6,4,4) | 4.2 mmHg | Standard Deviation 7.26 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 | Supine DBP: Change at Day 10 (n=9,2,5,3,6,4,4) | 6.0 mmHg | Standard Deviation 4.24 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 | Supine DBP: Baseline (n=9,2,5,4,6,5,6) | 61.5 mmHg | Standard Deviation 7.78 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 | Supine SBP: Baseline (n=9,2,5,4,6,5,6) | 106.5 mmHg | Standard Deviation 3.54 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 | Supine SBP: Change at Day 10 (n=9,2,5,3,6,4,4) | 12.5 mmHg | Standard Deviation 2.12 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 | Supine DBP: Baseline (n=9,2,5,4,6,5,6) | 56.2 mmHg | Standard Deviation 4.02 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 | Supine SBP: Change at Day 10 (n=9,2,5,3,6,4,4) | -0.2 mmHg | Standard Deviation 7.69 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 | Supine SBP: Baseline (n=9,2,5,4,6,5,6) | 103.6 mmHg | Standard Deviation 7.64 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 | Supine DBP: Change at Day 10 (n=9,2,5,3,6,4,4) | 2.2 mmHg | Standard Deviation 6.76 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 | Supine SBP: Baseline (n=9,2,5,4,6,5,6) | 110.3 mmHg | Standard Deviation 5.19 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 | Supine SBP: Change at Day 10 (n=9,2,5,3,6,4,4) | 8.7 mmHg | Standard Deviation 10.69 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 | Supine DBP: Baseline (n=9,2,5,4,6,5,6) | 65.5 mmHg | Standard Deviation 3.7 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 | Supine DBP: Change at Day 10 (n=9,2,5,3,6,4,4) | 5.7 mmHg | Standard Deviation 1.53 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 | Supine SBP: Baseline (n=9,2,5,4,6,5,6) | 111.5 mmHg | Standard Deviation 13.35 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 | Supine DBP: Change at Day 10 (n=9,2,5,3,6,4,4) | 3.2 mmHg | Standard Deviation 9.62 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 | Supine SBP: Change at Day 10 (n=9,2,5,3,6,4,4) | 7.7 mmHg | Standard Deviation 12.97 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 | Supine DBP: Baseline (n=9,2,5,4,6,5,6) | 68.8 mmHg | Standard Deviation 9.06 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 | Supine SBP: Change at Day 10 (n=9,2,5,3,6,4,4) | -3.5 mmHg | Standard Deviation 8.89 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 | Supine SBP: Baseline (n=9,2,5,4,6,5,6) | 108.6 mmHg | Standard Deviation 18.45 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 | Supine DBP: Baseline (n=9,2,5,4,6,5,6) | 59.2 mmHg | Standard Deviation 16.8 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 | Supine DBP: Change at Day 10 (n=9,2,5,3,6,4,4) | -4.3 mmHg | Standard Deviation 9.14 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 | Supine DBP: Baseline (n=9,2,5,4,6,5,6) | 66.2 mmHg | Standard Deviation 8.06 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 | Supine SBP: Baseline (n=9,2,5,4,6,5,6) | 115.8 mmHg | Standard Deviation 8.66 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 | Supine SBP: Change at Day 10 (n=9,2,5,3,6,4,4) | -5.3 mmHg | Standard Deviation 4.86 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 | Supine DBP: Change at Day 10 (n=9,2,5,3,6,4,4) | 2.0 mmHg | Standard Deviation 5.48 |
Primary
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Heart Rate at Day 10
Time frame: Baseline, 16 hours post-dose on Day 10
Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Heart Rate at Day 10 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 55.1 bpm | Standard Deviation 7.15 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Heart Rate at Day 10 | Change at Day 10 (n = 9, 2, 5, 3, 6, 4, 4) | -1.2 bpm | Standard Deviation 10.33 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Heart Rate at Day 10 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 55.5 bpm | Standard Deviation 2.12 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Heart Rate at Day 10 | Change at Day 10 (n = 9, 2, 5, 3, 6, 4, 4) | 7.7 bpm | Standard Deviation 6.13 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Heart Rate at Day 10 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 55.4 bpm | Standard Deviation 4.45 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Heart Rate at Day 10 | Change at Day 10 (n = 9, 2, 5, 3, 6, 4, 4) | -1.1 bpm | Standard Deviation 7.22 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Heart Rate at Day 10 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 61.0 bpm | Standard Deviation 2.94 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Heart Rate at Day 10 | Change at Day 10 (n = 9, 2, 5, 3, 6, 4, 4) | -3.0 bpm | Standard Deviation 4.04 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Heart Rate at Day 10 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 58.5 bpm | Standard Deviation 6.38 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Heart Rate at Day 10 | Change at Day 10 (n = 9, 2, 5, 3, 6, 4, 4) | -2.3 bpm | Standard Deviation 5.12 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Heart Rate at Day 10 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 63.0 bpm | Standard Deviation 7.38 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Heart Rate at Day 10 | Change at Day 10 (n = 9, 2, 5, 3, 6, 4, 4) | -1.8 bpm | Standard Deviation 5.79 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Heart Rate at Day 10 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 61.2 bpm | Standard Deviation 7.96 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Heart Rate at Day 10 | Change at Day 10 (n = 9, 2, 5, 3, 6, 4, 4) | -1.3 bpm | Standard Deviation 4.04 |
Primary
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Oral Temperature at Day 10
Time frame: Baseline, 16 hours post-dose on Day 10
Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Oral Temperature at Day 10 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 36.71 degree celsius | Standard Deviation 0.136 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Oral Temperature at Day 10 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4) | 0.08 degree celsius | Standard Deviation 0.228 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Oral Temperature at Day 10 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 36.70 degree celsius | Standard Deviation 0.141 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Oral Temperature at Day 10 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4) | 0.05 degree celsius | Standard Deviation 0.071 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Oral Temperature at Day 10 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 36.76 degree celsius | Standard Deviation 0.182 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Oral Temperature at Day 10 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4) | -0.22 degree celsius | Standard Deviation 0.164 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Oral Temperature at Day 10 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 36.68 degree celsius | Standard Deviation 0.126 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Oral Temperature at Day 10 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4) | -0.10 degree celsius | Standard Deviation 0.1 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Oral Temperature at Day 10 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 36.83 degree celsius | Standard Deviation 0.163 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Oral Temperature at Day 10 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4) | -0.22 degree celsius | Standard Deviation 0.214 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Oral Temperature at Day 10 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 36.76 degree celsius | Standard Deviation 0.167 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Oral Temperature at Day 10 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4) | -0.17 degree celsius | Standard Deviation 0.206 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Oral Temperature at Day 10 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 36.75 degree celsius | Standard Deviation 0.235 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Oral Temperature at Day 10 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4) | 0.05 degree celsius | Standard Deviation 0.208 |
Primary
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Pulse Rate at Day 10
Time frame: Baseline, 16 hours post-dose on Day 10
Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Pulse Rate at Day 10 | Baseline (n =9,2,5,4,6,5,6) | 59.3 bpm | Standard Deviation 12.58 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Pulse Rate at Day 10 | Change at Week 10 (n =9,2,5,3,6,4,4,) | -2.3 bpm | Standard Deviation 12.21 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Pulse Rate at Day 10 | Baseline (n =9,2,5,4,6,5,6) | 59.0 bpm | Standard Deviation 1.41 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Pulse Rate at Day 10 | Change at Week 10 (n =9,2,5,3,6,4,4,) | -0.5 bpm | Standard Deviation 0.71 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Pulse Rate at Day 10 | Baseline (n =9,2,5,4,6,5,6) | 55.8 bpm | Standard Deviation 7.36 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Pulse Rate at Day 10 | Change at Week 10 (n =9,2,5,3,6,4,4,) | -1.6 bpm | Standard Deviation 5.18 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Pulse Rate at Day 10 | Baseline (n =9,2,5,4,6,5,6) | 60.8 bpm | Standard Deviation 4.99 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Pulse Rate at Day 10 | Change at Week 10 (n =9,2,5,3,6,4,4,) | -4.0 bpm | Standard Deviation 7.21 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Pulse Rate at Day 10 | Baseline (n =9,2,5,4,6,5,6) | 61.5 bpm | Standard Deviation 7.5 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Pulse Rate at Day 10 | Change at Week 10 (n =9,2,5,3,6,4,4,) | -6.3 bpm | Standard Deviation 8.24 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Pulse Rate at Day 10 | Baseline (n =9,2,5,4,6,5,6) | 66.0 bpm | Standard Deviation 9.43 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Pulse Rate at Day 10 | Change at Week 10 (n =9,2,5,3,6,4,4,) | -2.5 bpm | Standard Deviation 4.43 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Pulse Rate at Day 10 | Baseline (n =9,2,5,4,6,5,6) | 60.5 bpm | Standard Deviation 9.61 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Pulse Rate at Day 10 | Change at Week 10 (n =9,2,5,3,6,4,4,) | -1.0 bpm | Standard Deviation 6.38 |
Primary
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28
Time frame: Baseline, 16 hours post-dose on Day 28
Population: FAS included all participants who received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28 | PR Interval: Baseline (n =9, 14, 7) | 169.4 msec | Standard Deviation 15.26 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28 | PR Interval: Change at Day 28 (n =8, 7, 5) | -0.6 msec | Standard Deviation 10.19 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28 | QRS Complex: Baseline (n =9, 14, 7) | 100.6 msec | Standard Deviation 8.32 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28 | QRS Complex: Change at Day 28 (n= 8, 7, 5) | 0.5 msec | Standard Deviation 4.86 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28 | QT Interval: Baseline (n =9, 14, 7) | 404.4 msec | Standard Deviation 17.48 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28 | QT Interval: Change at Day 28 (n =8, 7, 5) | -17.9 msec | Standard Deviation 16 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28 | QTC Interval: Baseline (n=9, 14, 7) | 409.7 msec | Standard Deviation 14.46 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28 | QTC Interval: Change at Day 28 (n= 8, 7, 5) | -8.7 msec | Standard Deviation 10.83 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28 | QRS Complex: Baseline (n =9, 14, 7) | 97.4 msec | Standard Deviation 10.27 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28 | QTC Interval: Baseline (n=9, 14, 7) | 409.0 msec | Standard Deviation 14.92 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28 | QRS Complex: Change at Day 28 (n= 8, 7, 5) | 0.8 msec | Standard Deviation 4.73 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28 | QT Interval: Baseline (n =9, 14, 7) | 411.6 msec | Standard Deviation 31.01 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28 | QT Interval: Change at Day 28 (n =8, 7, 5) | -22.6 msec | Standard Deviation 23.04 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28 | PR Interval: Baseline (n =9, 14, 7) | 156.1 msec | Standard Deviation 17.78 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28 | PR Interval: Change at Day 28 (n =8, 7, 5) | 11.1 msec | Standard Deviation 5.95 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28 | QTC Interval: Change at Day 28 (n= 8, 7, 5) | -9.6 msec | Standard Deviation 7.89 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28 | QRS Complex: Baseline (n =9, 14, 7) | 93.0 msec | Standard Deviation 5.87 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28 | PR Interval: Change at Day 28 (n =8, 7, 5) | 4.1 msec | Standard Deviation 7.09 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28 | PR Interval: Baseline (n =9, 14, 7) | 154.7 msec | Standard Deviation 11.51 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28 | QRS Complex: Change at Day 28 (n= 8, 7, 5) | 3.8 msec | Standard Deviation 5.26 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28 | QTC Interval: Baseline (n=9, 14, 7) | 392.0 msec | Standard Deviation 19.04 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28 | QT Interval: Change at Day 28 (n =8, 7, 5) | -5.3 msec | Standard Deviation 9.43 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28 | QT Interval: Baseline (n =9, 14, 7) | 379.0 msec | Standard Deviation 18.94 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 28 | QTC Interval: Change at Day 28 (n= 8, 7, 5) | -2.7 msec | Standard Deviation 13.18 |
Primary
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Blood Pressure at Day 28
Time frame: Baseline, 16 hours post-dose on Day 28
Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Blood Pressure at Day 28 | Supine SBP: Baseline (n =9, 14, 7) | 115.0 mmHg | Standard Deviation 13.21 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Blood Pressure at Day 28 | Supine SBP: Change at Day 28 (n =8, 7, 5) | -5.3 mmHg | Standard Deviation 11.87 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Blood Pressure at Day 28 | Supine DBP: Baseline (n =9, 14, 7) | 67.8 mmHg | Standard Deviation 7.93 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Blood Pressure at Day 28 | Supine DBP: Change at Day 28 (n =8, 7, 5) | -3.9 mmHg | Standard Deviation 5.51 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Blood Pressure at Day 28 | Supine DBP: Change at Day 28 (n =8, 7, 5) | -7.0 mmHg | Standard Deviation 6 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Blood Pressure at Day 28 | Supine SBP: Baseline (n =9, 14, 7) | 120.1 mmHg | Standard Deviation 10.91 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Blood Pressure at Day 28 | Supine DBP: Baseline (n =9, 14, 7) | 69.9 mmHg | Standard Deviation 7.94 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Blood Pressure at Day 28 | Supine SBP: Change at Day 28 (n =8, 7, 5) | -8.9 mmHg | Standard Deviation 9.94 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Blood Pressure at Day 28 | Supine DBP: Change at Day 28 (n =8, 7, 5) | -0.8 mmHg | Standard Deviation 16.96 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Blood Pressure at Day 28 | Supine SBP: Change at Day 28 (n =8, 7, 5) | 1.0 mmHg | Standard Deviation 11.94 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Blood Pressure at Day 28 | Supine DBP: Baseline (n =9, 14, 7) | 66.6 mmHg | Standard Deviation 7.55 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Blood Pressure at Day 28 | Supine SBP: Baseline (n =9, 14, 7) | 112.9 mmHg | Standard Deviation 8.11 |
Primary
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 28
Creatinine clearance is a measure of kidney function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time.
Time frame: Baseline, 16 hours post-dose on Day 28
Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, 'N' signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 28 | -10.0 mL/min | Standard Deviation 0 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 28 | -35.0 mL/min | Standard Deviation 33.94 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Creatinine Clearance at Day 28 | -67.6 mL/min | Standard Deviation 50.33 |
Primary
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Heart Rate at Day 28
Time frame: Baseline, 16 hours post-dose on Day 28
Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Heart Rate at Day 28 | Baseline (n =9, 14, 7) | 63.1 bpm | Standard Deviation 9.15 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Heart Rate at Day 28 | Change at Day 28 (n =8, 7, 5) | 5.2 bpm | Standard Deviation 5.28 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Heart Rate at Day 28 | Baseline (n =9, 14, 7) | 60.2 bpm | Standard Deviation 11.25 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Heart Rate at Day 28 | Change at Day 28 (n =8, 7, 5) | 4.0 bpm | Standard Deviation 8.73 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Heart Rate at Day 28 | Baseline (n =9, 14, 7) | 66.0 bpm | Standard Deviation 4.93 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Heart Rate at Day 28 | Change at Day 28 (n =8, 7, 5) | 1.4 bpm | Standard Deviation 5.6 |
Primary
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Oral Temperature at Day 28
Time frame: Baseline, 16 hours post-dose on Day 28
Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Oral Temperature at Day 28 | Baseline (n = 9, 14, 7) | 36.74 degrees celsius | Standard Deviation 0.151 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Oral Temperature at Day 28 | Change at Week 28 (n= 8, 7, 5) | 0.01 degrees celsius | Standard Deviation 0.223 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Oral Temperature at Day 28 | Baseline (n = 9, 14, 7) | 36.67 degrees celsius | Standard Deviation 0.213 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Oral Temperature at Day 28 | Change at Week 28 (n= 8, 7, 5) | -0.04 degrees celsius | Standard Deviation 0.369 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Oral Temperature at Day 28 | Baseline (n = 9, 14, 7) | 36.80 degrees celsius | Standard Deviation 0.277 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Oral Temperature at Day 28 | Change at Week 28 (n= 8, 7, 5) | -0.20 degrees celsius | Standard Deviation 0.3 |
Primary
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Pulse Rate at Day 28
Time frame: Baseline, 16 hours post-dose on Day 28
Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Pulse Rate at Day 28 | Baseline (n =9, 14, 7) | 61.8 bpm | Standard Deviation 8.07 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Pulse Rate at Day 28 | Change at Week 28 (n =8, 7, 5) | -1.9 bpm | Standard Deviation 5.38 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Pulse Rate at Day 28 | Baseline (n =9, 14, 7) | 61.4 bpm | Standard Deviation 9.52 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Pulse Rate at Day 28 | Change at Week 28 (n =8, 7, 5) | -5.3 bpm | Standard Deviation 7.41 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Pulse Rate at Day 28 | Baseline (n =9, 14, 7) | 64.9 bpm | Standard Deviation 6.04 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Pulse Rate at Day 28 | Change at Week 28 (n =8, 7, 5) | -3.0 bpm | Standard Deviation 3.39 |
Primary
Number of Adverse Events (AEs) According to Severity
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified according to the severity in 3 categories a) mild - AEs does not interfere with participant's usual function b) moderate - AEs interferes to some extent with participant's usual function c) severe - AEs interferes significantly with participant's usual function.
Time frame: SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37
Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: SAD Cohort | Number of Adverse Events (AEs) According to Severity | Moderate | 0 adverse events |
| Placebo: SAD Cohort | Number of Adverse Events (AEs) According to Severity | Mild | 2 adverse events |
| Placebo: SAD Cohort | Number of Adverse Events (AEs) According to Severity | Severe | 0 adverse events |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Number of Adverse Events (AEs) According to Severity | Severe | 0 adverse events |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Number of Adverse Events (AEs) According to Severity | Moderate | 0 adverse events |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Number of Adverse Events (AEs) According to Severity | Mild | 1 adverse events |
| PF--06700841: 3 mg SAD Cohort | Number of Adverse Events (AEs) According to Severity | Moderate | 0 adverse events |
| PF--06700841: 3 mg SAD Cohort | Number of Adverse Events (AEs) According to Severity | Severe | 0 adverse events |
| PF--06700841: 3 mg SAD Cohort | Number of Adverse Events (AEs) According to Severity | Mild | 1 adverse events |
| PF-06700841: 10 mg SAD Cohort | Number of Adverse Events (AEs) According to Severity | Severe | 0 adverse events |
| PF-06700841: 10 mg SAD Cohort | Number of Adverse Events (AEs) According to Severity | Mild | 0 adverse events |
| PF-06700841: 10 mg SAD Cohort | Number of Adverse Events (AEs) According to Severity | Moderate | 0 adverse events |
| PF-06700841: 30 mg SAD Cohort | Number of Adverse Events (AEs) According to Severity | Moderate | 0 adverse events |
| PF-06700841: 30 mg SAD Cohort | Number of Adverse Events (AEs) According to Severity | Mild | 1 adverse events |
| PF-06700841: 30 mg SAD Cohort | Number of Adverse Events (AEs) According to Severity | Severe | 0 adverse events |
| PF-06700841: 100 mg SAD Cohort | Number of Adverse Events (AEs) According to Severity | Severe | 0 adverse events |
| PF-06700841: 100 mg SAD Cohort | Number of Adverse Events (AEs) According to Severity | Mild | 4 adverse events |
| PF-06700841: 100 mg SAD Cohort | Number of Adverse Events (AEs) According to Severity | Moderate | 0 adverse events |
| PF-06700841: 200 mg SAD Cohort | Number of Adverse Events (AEs) According to Severity | Severe | 0 adverse events |
| PF-06700841: 200 mg SAD Cohort | Number of Adverse Events (AEs) According to Severity | Mild | 0 adverse events |
| PF-06700841: 200 mg SAD Cohort | Number of Adverse Events (AEs) According to Severity | Moderate | 0 adverse events |
| Placebo: Once Daily MAD Cohort | Number of Adverse Events (AEs) According to Severity | Moderate | 0 adverse events |
| Placebo: Once Daily MAD Cohort | Number of Adverse Events (AEs) According to Severity | Mild | 0 adverse events |
| Placebo: Once Daily MAD Cohort | Number of Adverse Events (AEs) According to Severity | Severe | 0 adverse events |
| Placebo: Twice Daily MAD Cohort | Number of Adverse Events (AEs) According to Severity | Severe | 0 adverse events |
| Placebo: Twice Daily MAD Cohort | Number of Adverse Events (AEs) According to Severity | Moderate | 0 adverse events |
| Placebo: Twice Daily MAD Cohort | Number of Adverse Events (AEs) According to Severity | Mild | 1 adverse events |
| PF-06700841: 10 mg Once Daily MAD Cohort | Number of Adverse Events (AEs) According to Severity | Severe | 0 adverse events |
| PF-06700841: 10 mg Once Daily MAD Cohort | Number of Adverse Events (AEs) According to Severity | Moderate | 0 adverse events |
| PF-06700841: 10 mg Once Daily MAD Cohort | Number of Adverse Events (AEs) According to Severity | Mild | 3 adverse events |
| PF-06700841: 30 mg Once Daily MAD Cohort | Number of Adverse Events (AEs) According to Severity | Moderate | 0 adverse events |
| PF-06700841: 30 mg Once Daily MAD Cohort | Number of Adverse Events (AEs) According to Severity | Mild | 2 adverse events |
| PF-06700841: 30 mg Once Daily MAD Cohort | Number of Adverse Events (AEs) According to Severity | Severe | 0 adverse events |
| PF-06700841: 100 mg Once Daily MAD Cohort | Number of Adverse Events (AEs) According to Severity | Moderate | 1 adverse events |
| PF-06700841: 100 mg Once Daily MAD Cohort | Number of Adverse Events (AEs) According to Severity | Severe | 0 adverse events |
| PF-06700841: 100 mg Once Daily MAD Cohort | Number of Adverse Events (AEs) According to Severity | Mild | 2 adverse events |
| PF-06700841: 50 mg Twice Daily MAD Cohort | Number of Adverse Events (AEs) According to Severity | Moderate | 0 adverse events |
| PF-06700841: 50 mg Twice Daily MAD Cohort | Number of Adverse Events (AEs) According to Severity | Severe | 0 adverse events |
| PF-06700841: 50 mg Twice Daily MAD Cohort | Number of Adverse Events (AEs) According to Severity | Mild | 6 adverse events |
| PF-06700841: 175 mg Once Daily MAD Cohort | Number of Adverse Events (AEs) According to Severity | Moderate | 1 adverse events |
| PF-06700841: 175 mg Once Daily MAD Cohort | Number of Adverse Events (AEs) According to Severity | Mild | 6 adverse events |
| PF-06700841: 175 mg Once Daily MAD Cohort | Number of Adverse Events (AEs) According to Severity | Severe | 0 adverse events |
| Placebo: MAD Psoriasis Cohort | Number of Adverse Events (AEs) According to Severity | Severe | 0 adverse events |
| Placebo: MAD Psoriasis Cohort | Number of Adverse Events (AEs) According to Severity | Mild | 7 adverse events |
| Placebo: MAD Psoriasis Cohort | Number of Adverse Events (AEs) According to Severity | Moderate | 0 adverse events |
| PF-06700841: 30 mg MAD Psoriasis Cohort | Number of Adverse Events (AEs) According to Severity | Moderate | 0 adverse events |
| PF-06700841: 30 mg MAD Psoriasis Cohort | Number of Adverse Events (AEs) According to Severity | Severe | 0 adverse events |
| PF-06700841: 30 mg MAD Psoriasis Cohort | Number of Adverse Events (AEs) According to Severity | Mild | 16 adverse events |
| PF-06700841: 100 mg MAD Psoriasis Cohort | Number of Adverse Events (AEs) According to Severity | Severe | 0 adverse events |
| PF-06700841: 100 mg MAD Psoriasis Cohort | Number of Adverse Events (AEs) According to Severity | Mild | 16 adverse events |
| PF-06700841: 100 mg MAD Psoriasis Cohort | Number of Adverse Events (AEs) According to Severity | Moderate | 0 adverse events |
| PF-06700841: 100 mg Tab Fasted (Food Effect Cohort) | Number of Adverse Events (AEs) According to Severity | Mild | 1 adverse events |
| PF-06700841: 100 mg Tab Fasted (Food Effect Cohort) | Number of Adverse Events (AEs) According to Severity | Moderate | 0 adverse events |
| PF-06700841: 100 mg Tab Fasted (Food Effect Cohort) | Number of Adverse Events (AEs) According to Severity | Severe | 0 adverse events |
| PF-06700841: 100 mg Solution Fasted (Food Effect Cohort) | Number of Adverse Events (AEs) According to Severity | Mild | 2 adverse events |
| PF-06700841: 100 mg Solution Fasted (Food Effect Cohort) | Number of Adverse Events (AEs) According to Severity | Severe | 0 adverse events |
| PF-06700841: 100 mg Solution Fasted (Food Effect Cohort) | Number of Adverse Events (AEs) According to Severity | Moderate | 0 adverse events |
| PF-06700841: 100 mg Tablet Fed (Food Effect Cohort) | Number of Adverse Events (AEs) According to Severity | Severe | 0 adverse events |
| PF-06700841: 100 mg Tablet Fed (Food Effect Cohort) | Number of Adverse Events (AEs) According to Severity | Moderate | 0 adverse events |
| PF-06700841: 100 mg Tablet Fed (Food Effect Cohort) | Number of Adverse Events (AEs) According to Severity | Mild | 0 adverse events |
Primary
Number of Participants With Change From Baseline in Physical Examinations
Physical examinations included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems.
Time frame: SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37
Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo: SAD Cohort | Number of Participants With Change From Baseline in Physical Examinations | 0 participants |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Number of Participants With Change From Baseline in Physical Examinations | 0 participants |
| PF--06700841: 3 mg SAD Cohort | Number of Participants With Change From Baseline in Physical Examinations | 0 participants |
| PF-06700841: 10 mg SAD Cohort | Number of Participants With Change From Baseline in Physical Examinations | 0 participants |
| PF-06700841: 30 mg SAD Cohort | Number of Participants With Change From Baseline in Physical Examinations | 0 participants |
| PF-06700841: 100 mg SAD Cohort | Number of Participants With Change From Baseline in Physical Examinations | 0 participants |
| PF-06700841: 200 mg SAD Cohort | Number of Participants With Change From Baseline in Physical Examinations | 0 participants |
| Placebo: Once Daily MAD Cohort | Number of Participants With Change From Baseline in Physical Examinations | 0 participants |
| Placebo: Twice Daily MAD Cohort | Number of Participants With Change From Baseline in Physical Examinations | 0 participants |
| PF-06700841: 10 mg Once Daily MAD Cohort | Number of Participants With Change From Baseline in Physical Examinations | 0 participants |
| PF-06700841: 30 mg Once Daily MAD Cohort | Number of Participants With Change From Baseline in Physical Examinations | 0 participants |
| PF-06700841: 100 mg Once Daily MAD Cohort | Number of Participants With Change From Baseline in Physical Examinations | 0 participants |
| PF-06700841: 50 mg Twice Daily MAD Cohort | Number of Participants With Change From Baseline in Physical Examinations | 0 participants |
| PF-06700841: 175 mg Once Daily MAD Cohort | Number of Participants With Change From Baseline in Physical Examinations | 0 participants |
| Placebo: MAD Psoriasis Cohort | Number of Participants With Change From Baseline in Physical Examinations | 0 participants |
| PF-06700841: 30 mg MAD Psoriasis Cohort | Number of Participants With Change From Baseline in Physical Examinations | 3 participants |
| PF-06700841: 100 mg MAD Psoriasis Cohort | Number of Participants With Change From Baseline in Physical Examinations | 0 participants |
| PF-06700841: 100 mg Tab Fasted (Food Effect Cohort) | Number of Participants With Change From Baseline in Physical Examinations | 0 participants |
| PF-06700841: 100 mg Solution Fasted (Food Effect Cohort) | Number of Participants With Change From Baseline in Physical Examinations | 0 participants |
| PF-06700841: 100 mg Tablet Fed (Food Effect Cohort) | Number of Participants With Change From Baseline in Physical Examinations | 0 participants |
Primary
Number of Participants With Laboratory Abnormalities
Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count: less than(\<) 0.8\*lower limit of normal (LLN); mean corpuscular volume; mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration: \<0.9\*LLN,\>1.1\*upper limit of normal (ULN); platelets: \<0.5\*LLN,\>1.75\*ULN, white blood cell count: \<0.6\*LLN, \>1.5\*ULN; lymphocytes, total neutrophils: \<0.8\*LLN, \>1.2\*ULN; eosinophils, basophils, monocytes: \>1.2\*ULN; coagulation: activated partial thromboplastin time, prothrombin, prothrombin international ratio: \>1.1\*ULN; liver function: bilirubin: \>1.5\*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: \>3.0\*ULN; protein, albumin: \<0.8\*LLN\>\</0\>1.2\*ULN; renal function:blood urea nitrogen,creatinine: \>1.3\*ULN; uric acid: \>1.2\*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: \<0.9\*LLN,\>1.1\*ULN; urinalysis: pH\<4.5, \>8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: \<0.6\*LLN,\>1.5\*ULN)
Time frame: SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37
Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo: SAD Cohort | Number of Participants With Laboratory Abnormalities | 7 participants |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Number of Participants With Laboratory Abnormalities | 4 participants |
| PF--06700841: 3 mg SAD Cohort | Number of Participants With Laboratory Abnormalities | 4 participants |
| PF-06700841: 10 mg SAD Cohort | Number of Participants With Laboratory Abnormalities | 6 participants |
| PF-06700841: 30 mg SAD Cohort | Number of Participants With Laboratory Abnormalities | 6 participants |
| PF-06700841: 100 mg SAD Cohort | Number of Participants With Laboratory Abnormalities | 6 participants |
| PF-06700841: 200 mg SAD Cohort | Number of Participants With Laboratory Abnormalities | 7 participants |
| Placebo: Once Daily MAD Cohort | Number of Participants With Laboratory Abnormalities | 6 participants |
| Placebo: Twice Daily MAD Cohort | Number of Participants With Laboratory Abnormalities | 0 participants |
| PF-06700841: 10 mg Once Daily MAD Cohort | Number of Participants With Laboratory Abnormalities | 5 participants |
| PF-06700841: 30 mg Once Daily MAD Cohort | Number of Participants With Laboratory Abnormalities | 4 participants |
| PF-06700841: 100 mg Once Daily MAD Cohort | Number of Participants With Laboratory Abnormalities | 6 participants |
| PF-06700841: 50 mg Twice Daily MAD Cohort | Number of Participants With Laboratory Abnormalities | 5 participants |
| PF-06700841: 175 mg Once Daily MAD Cohort | Number of Participants With Laboratory Abnormalities | 6 participants |
| Placebo: MAD Psoriasis Cohort | Number of Participants With Laboratory Abnormalities | 7 participants |
| PF-06700841: 30 mg MAD Psoriasis Cohort | Number of Participants With Laboratory Abnormalities | 13 participants |
| PF-06700841: 100 mg MAD Psoriasis Cohort | Number of Participants With Laboratory Abnormalities | 7 participants |
| PF-06700841: 100 mg Tab Fasted (Food Effect Cohort) | Number of Participants With Laboratory Abnormalities | 5 participants |
| PF-06700841: 100 mg Solution Fasted (Food Effect Cohort) | Number of Participants With Laboratory Abnormalities | 1 participants |
| PF-06700841: 100 mg Tablet Fed (Food Effect Cohort) | Number of Participants With Laboratory Abnormalities | 3 participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug up to the end of study (up to Day 8 in SAD cohort, Day 28 in MAD cohort, Day 56 in MAD Psoriasis cohort, Day 37 in Food effect cohort), that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAE and non-SAE.
Time frame: SAD Cohort: Baseline up to Day 8, MAD Cohort: Baseline up to Day 28, MAD Psoriasis Cohort: Baseline up to Day 56, Food Effect Cohort: Baseline up to Day 37
Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: SAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | SAEs | 0 participants |
| Placebo: SAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | AEs | 2 participants |
| Placebo: SAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | Withdrawal due to AEs | 0 participants |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | AEs | 1 participants |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | Withdrawal due to AEs | 0 participants |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | SAEs | 0 participants |
| PF--06700841: 3 mg SAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | SAEs | 0 participants |
| PF--06700841: 3 mg SAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | AEs | 1 participants |
| PF--06700841: 3 mg SAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | Withdrawal due to AEs | 0 participants |
| PF-06700841: 10 mg SAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | AEs | 0 participants |
| PF-06700841: 10 mg SAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | SAEs | 0 participants |
| PF-06700841: 10 mg SAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | Withdrawal due to AEs | 0 participants |
| PF-06700841: 30 mg SAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | Withdrawal due to AEs | 0 participants |
| PF-06700841: 30 mg SAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | SAEs | 0 participants |
| PF-06700841: 30 mg SAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | AEs | 1 participants |
| PF-06700841: 100 mg SAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | AEs | 3 participants |
| PF-06700841: 100 mg SAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | SAEs | 0 participants |
| PF-06700841: 100 mg SAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | Withdrawal due to AEs | 0 participants |
| PF-06700841: 200 mg SAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | Withdrawal due to AEs | 0 participants |
| PF-06700841: 200 mg SAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | SAEs | 0 participants |
| PF-06700841: 200 mg SAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | AEs | 2 participants |
| Placebo: Once Daily MAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | AEs | 0 participants |
| Placebo: Once Daily MAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | SAEs | 0 participants |
| Placebo: Once Daily MAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | Withdrawal due to AEs | 0 participants |
| Placebo: Twice Daily MAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | SAEs | 0 participants |
| Placebo: Twice Daily MAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | Withdrawal due to AEs | 0 participants |
| Placebo: Twice Daily MAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | AEs | 1 participants |
| PF-06700841: 10 mg Once Daily MAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | AEs | 3 participants |
| PF-06700841: 10 mg Once Daily MAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | Withdrawal due to AEs | 0 participants |
| PF-06700841: 10 mg Once Daily MAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | SAEs | 0 participants |
| PF-06700841: 30 mg Once Daily MAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | AEs | 2 participants |
| PF-06700841: 30 mg Once Daily MAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | SAEs | 0 participants |
| PF-06700841: 30 mg Once Daily MAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | Withdrawal due to AEs | 0 participants |
| PF-06700841: 100 mg Once Daily MAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | AEs | 3 participants |
| PF-06700841: 100 mg Once Daily MAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | Withdrawal due to AEs | 0 participants |
| PF-06700841: 100 mg Once Daily MAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | SAEs | 0 participants |
| PF-06700841: 50 mg Twice Daily MAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | SAEs | 0 participants |
| PF-06700841: 50 mg Twice Daily MAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | Withdrawal due to AEs | 0 participants |
| PF-06700841: 50 mg Twice Daily MAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | AEs | 5 participants |
| PF-06700841: 175 mg Once Daily MAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | AEs | 5 participants |
| PF-06700841: 175 mg Once Daily MAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | SAEs | 0 participants |
| PF-06700841: 175 mg Once Daily MAD Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | Withdrawal due to AEs | 0 participants |
| Placebo: MAD Psoriasis Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | AEs | 5 participants |
| Placebo: MAD Psoriasis Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | Withdrawal due to AEs | 0 participants |
| Placebo: MAD Psoriasis Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | SAEs | 0 participants |
| PF-06700841: 30 mg MAD Psoriasis Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | AEs | 11 participants |
| PF-06700841: 30 mg MAD Psoriasis Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | Withdrawal due to AEs | 6 participants |
| PF-06700841: 30 mg MAD Psoriasis Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | SAEs | 0 participants |
| PF-06700841: 100 mg MAD Psoriasis Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | SAEs | 0 participants |
| PF-06700841: 100 mg MAD Psoriasis Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | Withdrawal due to AEs | 1 participants |
| PF-06700841: 100 mg MAD Psoriasis Cohort | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | AEs | 6 participants |
| PF-06700841: 100 mg Tab Fasted (Food Effect Cohort) | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | SAEs | 0 participants |
| PF-06700841: 100 mg Tab Fasted (Food Effect Cohort) | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | AEs | 1 participants |
| PF-06700841: 100 mg Tab Fasted (Food Effect Cohort) | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | Withdrawal due to AEs | 0 participants |
| PF-06700841: 100 mg Solution Fasted (Food Effect Cohort) | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | SAEs | 0 participants |
| PF-06700841: 100 mg Solution Fasted (Food Effect Cohort) | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | Withdrawal due to AEs | 0 participants |
| PF-06700841: 100 mg Solution Fasted (Food Effect Cohort) | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | AEs | 2 participants |
| PF-06700841: 100 mg Tablet Fed (Food Effect Cohort) | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | AEs | 0 participants |
| PF-06700841: 100 mg Tablet Fed (Food Effect Cohort) | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | SAEs | 0 participants |
| PF-06700841: 100 mg Tablet Fed (Food Effect Cohort) | Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | Withdrawal due to AEs | 0 participants |
Primary
Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1
Time frame: Baseline, 24 hours post-dose on Day 1
Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QRS Complex: Baseline | 97.7 millisecond (msec) | Standard Deviation 15.4 |
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | PR Interval: Change at Day 1 | -0.9 millisecond (msec) | Standard Deviation 6.78 |
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | PR Interval: Baseline | 175.7 millisecond (msec) | Standard Deviation 14.52 |
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QRS Complex: Change at Day 1 | -3.1 millisecond (msec) | Standard Deviation 12.73 |
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QT Interval: Baseline | 408.4 millisecond (msec) | Standard Deviation 21.42 |
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QT Interval: Change at Day 1 | -5.9 millisecond (msec) | Standard Deviation 10.41 |
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QTC Interval: Baseline | 397.7 millisecond (msec) | Standard Deviation 16.51 |
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QTC Interval: Change at Day 1 | -0.2 millisecond (msec) | Standard Deviation 9.24 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | PR Interval: Change at Day 1 | 6.7 millisecond (msec) | Standard Deviation 8.12 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QTC Interval: Change at Day 1 | -2.3 millisecond (msec) | Standard Deviation 5.45 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QRS Complex: Baseline | 92.9 millisecond (msec) | Standard Deviation 9.3 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QRS Complex: Change at Day 1 | -1.5 millisecond (msec) | Standard Deviation 5.98 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QT Interval: Baseline | 374.0 millisecond (msec) | Standard Deviation 21.81 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QT Interval: Change at Day 1 | -3.8 millisecond (msec) | Standard Deviation 10.21 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QTC Interval: Baseline | 390.9 millisecond (msec) | Standard Deviation 20.95 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | PR Interval: Baseline | 149.7 millisecond (msec) | Standard Deviation 18.62 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QRS Complex: Baseline | 97.4 millisecond (msec) | Standard Deviation 10.43 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QTC Interval: Change at Day 1 | -1.9 millisecond (msec) | Standard Deviation 7.61 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QRS Complex: Change at Day 1 | -2.2 millisecond (msec) | Standard Deviation 4.06 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QT Interval: Baseline | 384.3 millisecond (msec) | Standard Deviation 26.2 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QT Interval: Change at Day 1 | -3.1 millisecond (msec) | Standard Deviation 9.43 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QTC Interval: Baseline | 400.6 millisecond (msec) | Standard Deviation 11.9 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | PR Interval: Change at Day 1 | -2.4 millisecond (msec) | Standard Deviation 6.65 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | PR Interval: Baseline | 163.1 millisecond (msec) | Standard Deviation 13.58 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QRS Complex: Change at Day 1 | -1.7 millisecond (msec) | Standard Deviation 3.55 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QTC Interval: Change at Day 1 | 2.4 millisecond (msec) | Standard Deviation 9.42 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QT Interval: Baseline | 404.2 millisecond (msec) | Standard Deviation 19.89 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QT Interval: Change at Day 1 | -8.2 millisecond (msec) | Standard Deviation 9.25 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QTC Interval: Baseline | 392.2 millisecond (msec) | Standard Deviation 13.42 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QRS Complex: Baseline | 102.9 millisecond (msec) | Standard Deviation 8.74 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | PR Interval: Baseline | 168.2 millisecond (msec) | Standard Deviation 14.63 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | PR Interval: Change at Day 1 | 2.2 millisecond (msec) | Standard Deviation 5.45 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QT Interval: Baseline | 387.5 millisecond (msec) | Standard Deviation 12 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QTC Interval: Change at Day 1 | -4.6 millisecond (msec) | Standard Deviation 4.41 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QT Interval: Change at Day 1 | -0.8 millisecond (msec) | Standard Deviation 4.56 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QTC Interval: Baseline | 402.7 millisecond (msec) | Standard Deviation 20.69 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QRS Complex: Change at Day 1 | -2.9 millisecond (msec) | Standard Deviation 3.45 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | PR Interval: Baseline | 163.6 millisecond (msec) | Standard Deviation 19.37 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | PR Interval: Change at Day 1 | -2.1 millisecond (msec) | Standard Deviation 5.95 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QRS Complex: Baseline | 99.8 millisecond (msec) | Standard Deviation 14.61 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QT Interval: Change at Day 1 | -0.8 millisecond (msec) | Standard Deviation 11.61 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QTC Interval: Change at Day 1 | 4.2 millisecond (msec) | Standard Deviation 7.75 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QTC Interval: Baseline | 400.0 millisecond (msec) | Standard Deviation 7.6 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QT Interval: Baseline | 421.3 millisecond (msec) | Standard Deviation 29.94 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | PR Interval: Baseline | 175.8 millisecond (msec) | Standard Deviation 18.86 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | PR Interval: Change at Day 1 | 3.3 millisecond (msec) | Standard Deviation 5.62 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QRS Complex: Baseline | 101.7 millisecond (msec) | Standard Deviation 6.87 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QRS Complex: Change at Day 1 | -2.0 millisecond (msec) | Standard Deviation 5.19 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QTC Interval: Baseline | 402.7 millisecond (msec) | Standard Deviation 14.1 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QT Interval: Change at Day 1 | -3.3 millisecond (msec) | Standard Deviation 14.78 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QTC Interval: Change at Day 1 | 3.2 millisecond (msec) | Standard Deviation 5.76 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | PR Interval: Baseline | 165.9 millisecond (msec) | Standard Deviation 7.65 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | PR Interval: Change at Day 1 | 0.5 millisecond (msec) | Standard Deviation 7.54 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QRS Complex: Baseline | 92.0 millisecond (msec) | Standard Deviation 5.81 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QRS Complex: Change at Day 1 | 1.7 millisecond (msec) | Standard Deviation 2.33 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in 12-Lead Electrocardiogram (ECG) Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval) at Day 1 | QT Interval: Baseline | 407.1 millisecond (msec) | Standard Deviation 20.71 |
Primary
Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1
Time frame: Baseline, 24 hours post-dose on Day 1
Population: Full analysis set (FAS) included all participants who were randomized to treatment and received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 | Supine Systolic Blood Pressure (SBP): Baseline | 114.2 millimeter of mercury (mmHg) | Standard Deviation 11.97 |
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 | Supine SBP: Change at Day 1 | -2.6 millimeter of mercury (mmHg) | Standard Deviation 6.4 |
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 | Supine Diastolic blood pressure (DBP): Baseline | 64.0 millimeter of mercury (mmHg) | Standard Deviation 8.55 |
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 | Supine DBP: Change at Day 1 | -1.1 millimeter of mercury (mmHg) | Standard Deviation 7.44 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 | Supine DBP: Change at Day 1 | -5.3 millimeter of mercury (mmHg) | Standard Deviation 9.05 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 | Supine Diastolic blood pressure (DBP): Baseline | 67.0 millimeter of mercury (mmHg) | Standard Deviation 8.77 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 | Supine Systolic Blood Pressure (SBP): Baseline | 110.6 millimeter of mercury (mmHg) | Standard Deviation 6.7 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 | Supine SBP: Change at Day 1 | -8.1 millimeter of mercury (mmHg) | Standard Deviation 9.32 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 | Supine Diastolic blood pressure (DBP): Baseline | 66.2 millimeter of mercury (mmHg) | Standard Deviation 8.42 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 | Supine SBP: Change at Day 1 | 1.0 millimeter of mercury (mmHg) | Standard Deviation 8.17 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 | Supine Systolic Blood Pressure (SBP): Baseline | 108.7 millimeter of mercury (mmHg) | Standard Deviation 7.76 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 | Supine DBP: Change at Day 1 | 2.2 millimeter of mercury (mmHg) | Standard Deviation 9.56 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 | Supine Systolic Blood Pressure (SBP): Baseline | 102.8 millimeter of mercury (mmHg) | Standard Deviation 6.62 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 | Supine SBP: Change at Day 1 | 9.5 millimeter of mercury (mmHg) | Standard Deviation 5.96 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 | Supine Diastolic blood pressure (DBP): Baseline | 58.7 millimeter of mercury (mmHg) | Standard Deviation 8.19 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 | Supine DBP: Change at Day 1 | 4.7 millimeter of mercury (mmHg) | Standard Deviation 715 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 | Supine Systolic Blood Pressure (SBP): Baseline | 117.8 millimeter of mercury (mmHg) | Standard Deviation 9.54 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 | Supine DBP: Change at Day 1 | 2.5 millimeter of mercury (mmHg) | Standard Deviation 8.83 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 | Supine SBP: Change at Day 1 | -1.5 millimeter of mercury (mmHg) | Standard Deviation 4.64 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 | Supine Diastolic blood pressure (DBP): Baseline | 70.3 millimeter of mercury (mmHg) | Standard Deviation 7.39 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 | Supine SBP: Change at Day 1 | 2.1 millimeter of mercury (mmHg) | Standard Deviation 11.28 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 | Supine Systolic Blood Pressure (SBP): Baseline | 112.4 millimeter of mercury (mmHg) | Standard Deviation 12.26 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 | Supine Diastolic blood pressure (DBP): Baseline | 66.9 millimeter of mercury (mmHg) | Standard Deviation 8.98 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 | Supine DBP: Change at Day 1 | -0.1 millimeter of mercury (mmHg) | Standard Deviation 8.36 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 | Supine Diastolic blood pressure (DBP): Baseline | 70.5 millimeter of mercury (mmHg) | Standard Deviation 5.88 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 | Supine Systolic Blood Pressure (SBP): Baseline | 115.3 millimeter of mercury (mmHg) | Standard Deviation 5.99 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 | Supine SBP: Change at Day 1 | -5.3 millimeter of mercury (mmHg) | Standard Deviation 7.91 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 | Supine DBP: Change at Day 1 | -2.3 millimeter of mercury (mmHg) | Standard Deviation 6.14 |
Primary
Single Ascending Dose (SAD) Cohort: Change From Baseline in Creatinine Clearance at Day 1
Creatinine clearance is a measure of kidney function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time.
Time frame: Baseline, 24 hours post-dose on Day 1
Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Creatinine Clearance at Day 1 | Change at Day 1 | 24.3 milliliter per minute (mL/min) | Standard Deviation 63.75 |
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Creatinine Clearance at Day 1 | Baseline | 117.7 milliliter per minute (mL/min) | Standard Deviation 28.7 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Creatinine Clearance at Day 1 | Baseline | 93.0 milliliter per minute (mL/min) | Standard Deviation 36.6 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Creatinine Clearance at Day 1 | Change at Day 1 | -0.4 milliliter per minute (mL/min) | Standard Deviation 35.35 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Creatinine Clearance at Day 1 | Baseline | 133.8 milliliter per minute (mL/min) | Standard Deviation 29.76 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Creatinine Clearance at Day 1 | Change at Day 1 | -2.7 milliliter per minute (mL/min) | Standard Deviation 11.27 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Creatinine Clearance at Day 1 | Change at Day 1 | 15.8 milliliter per minute (mL/min) | Standard Deviation 36.79 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Creatinine Clearance at Day 1 | Baseline | 95.8 milliliter per minute (mL/min) | Standard Deviation 53.07 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Creatinine Clearance at Day 1 | Baseline | 117.0 milliliter per minute (mL/min) | Standard Deviation 28.7 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Creatinine Clearance at Day 1 | Change at Day 1 | -6.4 milliliter per minute (mL/min) | Standard Deviation 6.35 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Creatinine Clearance at Day 1 | Baseline | 129.6 milliliter per minute (mL/min) | Standard Deviation 25.43 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Creatinine Clearance at Day 1 | Change at Day 1 | -17.6 milliliter per minute (mL/min) | Standard Deviation 28.67 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Creatinine Clearance at Day 1 | Baseline | 114.4 milliliter per minute (mL/min) | Standard Deviation 24.64 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Creatinine Clearance at Day 1 | Change at Day 1 | 73.4 milliliter per minute (mL/min) | Standard Deviation 227.5 |
Primary
Single Ascending Dose (SAD) Cohort: Change From Baseline in Heart Rate at Day 1
Time frame: Baseline, 24 hours post-dose on Day 1
Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Heart Rate at Day 1 | Baseline | 56.1 bpm | Standard Deviation 6.83 |
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Heart Rate at Day 1 | Change at Day 1 | 2.2 bpm | Standard Deviation 3.74 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Heart Rate at Day 1 | Baseline | 70.3 bpm | Standard Deviation 16.46 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Heart Rate at Day 1 | Change at Day 1 | 1.6 bpm | Standard Deviation 2.81 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Heart Rate at Day 1 | Baseline | 69.2 bpm | Standard Deviation 12.06 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Heart Rate at Day 1 | Change at Day 1 | 0.3 bpm | Standard Deviation 3.27 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Heart Rate at Day 1 | Baseline | 55.3 bpm | Standard Deviation 5.65 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Heart Rate at Day 1 | Change at Day 1 | 4.6 bpm | Standard Deviation 4.64 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Heart Rate at Day 1 | Baseline | 67.7 bpm | Standard Deviation 8.82 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Heart Rate at Day 1 | Change at Day 1 | -2.3 bpm | Standard Deviation 1.72 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Heart Rate at Day 1 | Baseline | 53.0 bpm | Standard Deviation 8.92 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Heart Rate at Day 1 | Change at Day 1 | 2.0 bpm | Standard Deviation 3.19 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Heart Rate at Day 1 | Baseline | 58.0 bpm | Standard Deviation 5.17 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Heart Rate at Day 1 | Change at Day 1 | 3.4 bpm | Standard Deviation 5.79 |
Primary
Single Ascending Dose (SAD) Cohort: Change From Baseline in Oral Temperature at Day 1
Time frame: Baseline, 24 hours post-dose on Day 1
Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Oral Temperature at Day 1 | Change at Day 1 | 0.05 degree celsius | Standard Deviation 0.151 |
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Oral Temperature at Day 1 | Baseline | 36.79 degree celsius | Standard Deviation 0.155 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Oral Temperature at Day 1 | Baseline | 36.83 degree celsius | Standard Deviation 0.359 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Oral Temperature at Day 1 | Change at Day 1 | -0.11 degree celsius | Standard Deviation 0.418 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Oral Temperature at Day 1 | Change at Day 1 | 0.35 degree celsius | Standard Deviation 0.281 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Oral Temperature at Day 1 | Baseline | 36.65 degree celsius | Standard Deviation 0.187 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Oral Temperature at Day 1 | Baseline | 36.82 degree celsius | Standard Deviation 0.194 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Oral Temperature at Day 1 | Change at Day 1 | 0.05 degree celsius | Standard Deviation 0.235 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Oral Temperature at Day 1 | Change at Day 1 | 0.07 degree celsius | Standard Deviation 0.103 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Oral Temperature at Day 1 | Baseline | 36.80 degree celsius | Standard Deviation 0.141 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Oral Temperature at Day 1 | Baseline | 36.69 degree celsius | Standard Deviation 0.164 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Oral Temperature at Day 1 | Change at Day 1 | -0.03 degree celsius | Standard Deviation 0.238 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Oral Temperature at Day 1 | Change at Day 1 | 0.05 degree celsius | Standard Deviation 0.177 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Oral Temperature at Day 1 | Baseline | 36.63 degree celsius | Standard Deviation 0.149 |
Primary
Single Ascending Dose (SAD) Cohort: Change From Baseline in Pulse Rate at Day 1
Time frame: Baseline, 24 hours post-dose on Day 1
Population: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Pulse Rate at Day 1 | Baseline | 57.5 beats per minute (bpm) | Standard Deviation 6.36 |
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Pulse Rate at Day 1 | Change at Day 1 | 1.0 beats per minute (bpm) | Standard Deviation 3.42 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Pulse Rate at Day 1 | Baseline | 68.6 beats per minute (bpm) | Standard Deviation 13.81 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Pulse Rate at Day 1 | Change at Day 1 | 6.1 beats per minute (bpm) | Standard Deviation 7.58 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Pulse Rate at Day 1 | Baseline | 67.2 beats per minute (bpm) | Standard Deviation 9.66 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Pulse Rate at Day 1 | Change at Day 1 | 2.5 beats per minute (bpm) | Standard Deviation 6.28 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Pulse Rate at Day 1 | Baseline | 56.0 beats per minute (bpm) | Standard Deviation 8.05 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Pulse Rate at Day 1 | Change at Day 1 | 3.0 beats per minute (bpm) | Standard Deviation 8.1 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Pulse Rate at Day 1 | Baseline | 67.3 beats per minute (bpm) | Standard Deviation 9.24 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Pulse Rate at Day 1 | Change at Day 1 | 0.7 beats per minute (bpm) | Standard Deviation 5.54 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Pulse Rate at Day 1 | Baseline | 55.8 beats per minute (bpm) | Standard Deviation 11.77 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Pulse Rate at Day 1 | Change at Day 1 | -1.1 beats per minute (bpm) | Standard Deviation 3.94 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Pulse Rate at Day 1 | Baseline | 57.8 beats per minute (bpm) | Standard Deviation 6.54 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Pulse Rate at Day 1 | Change at Day 1 | 2.6 beats per minute (bpm) | Standard Deviation 6.39 |
Secondary
Food Effect Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF--06700841
Time frame: Pre--dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1
Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Placebo: SAD Cohort | Food Effect Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF--06700841 | 0.500 hour | Full Range 0.5 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Food Effect Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF--06700841 | 1.00 hour | Full Range 1.2965 |
| PF--06700841: 3 mg SAD Cohort | Food Effect Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF--06700841 | 4.00 hour | Full Range 1.4383 |
Secondary
Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06700841
Area under the plasma concentration versus time curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort and 24 hours for MAD Psoriasis cohort.
Time frame: MAD: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5,1,2,4,6,8,12,16,24 hours post dose on Day 28
Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: MAD Cohort, MAD Psoriasis Cohort arm
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06700841 | 422.8 ng*hr/mL | Geometric Coefficient of Variation 41 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06700841 | 1880 ng*hr/mL | Geometric Coefficient of Variation 52 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06700841 | 6089 ng*hr/mL | Geometric Coefficient of Variation 38 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06700841 | 3560 ng*hr/mL | Geometric Coefficient of Variation 35 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06700841 | 16180 ng*hr/mL | Geometric Coefficient of Variation 15 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06700841 | 990.0 ng*hr/mL | Geometric Coefficient of Variation 103 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06700841 | 7672 ng*hr/mL | Geometric Coefficient of Variation 43 |
Secondary
Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Peak-Trough Fluctuation (PTF) of PF-06700841
PTF was calculated as: Cmax-Cmin/Cavg. Cmax is the maximum observed plasma concentration of PF-06700841. Cmin is the minimum observed plasma concentration of PF-06700841. Cavg is the average observed plasma concentration of PF-06700841 calculated as area under the plasma concentration-time curve during a dosing Interval (AUC\[tau\]) divided by the dosing interval (tau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort and 24 hours for MAD Psoriasis cohort.
Time frame: MAD: pre--dose 0.5, 1, 2, 4, 6, 8, 12, 24 hour post--dose on Day 10; MAD Psoriasis: pre--dose, 0.5,1,2,4,6,8,12,16,24 hours post-dose on Day 28
Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: MAD Cohort, MAD Psoriasis Cohort arm.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Peak-Trough Fluctuation (PTF) of PF-06700841 | 2.815 ratio | Geometric Coefficient of Variation 40 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Peak-Trough Fluctuation (PTF) of PF-06700841 | 3.543 ratio | Geometric Coefficient of Variation 38 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Peak-Trough Fluctuation (PTF) of PF-06700841 | 2.643 ratio | Geometric Coefficient of Variation 31 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Peak-Trough Fluctuation (PTF) of PF-06700841 | 1.297 ratio | Geometric Coefficient of Variation 22 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Peak-Trough Fluctuation (PTF) of PF-06700841 | 2.911 ratio | Geometric Coefficient of Variation 43 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Peak-Trough Fluctuation (PTF) of PF-06700841 | 3.414 ratio | Geometric Coefficient of Variation 44 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Peak-Trough Fluctuation (PTF) of PF-06700841 | 2.654 ratio | Geometric Coefficient of Variation 42 |
Secondary
Multiple Ascending Dose (MAD) Cohort: Amount of PF-06700841 Recovered Unchanged in the Urine Over the Time Interval Tau (Aetau)
Aetau is the amount of drug recovered unchanged in urine during the dosing interval (tau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort.
Time frame: 0-24 hour on Day 10
Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo Once Daily and Twice Daily: MAD Cohort arms.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Amount of PF-06700841 Recovered Unchanged in the Urine Over the Time Interval Tau (Aetau) | 1.109 milligram | Geometric Coefficient of Variation 45 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Amount of PF-06700841 Recovered Unchanged in the Urine Over the Time Interval Tau (Aetau) | 2.798 milligram | Geometric Coefficient of Variation 57 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Amount of PF-06700841 Recovered Unchanged in the Urine Over the Time Interval Tau (Aetau) | NA milligram | — |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Amount of PF-06700841 Recovered Unchanged in the Urine Over the Time Interval Tau (Aetau) | 7.758 milligram | Geometric Coefficient of Variation 57 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Amount of PF-06700841 Recovered Unchanged in the Urine Over the Time Interval Tau (Aetau) | 15.60 milligram | Geometric Coefficient of Variation 44 |
Secondary
Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28
Serum samples for hsCRP were analyzed using a validated analytical assay. Reference range for measurement of CRP was 0.015 to 2.0 mg/dL. LLOQ for hsCRP was 0.03 mg/dL and limit of detection was 0.015 mg/dL.
Time frame: Baseline, Day 2, 5, 10, 11, 28
Population: PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 28 (n= 9, 2, 5, 3, 6, 4, 4) | 0.0496 mg/dL | Standard Deviation 0.18748 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 2 (n= 9, 2, 5, 4, 6, 5, 6) | -0.0148 mg/dL | Standard Deviation 0.03176 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 10 (n= 9, 2, 5, 3, 6, 4, 4) | -0.0329 mg/dL | Standard Deviation 0.05656 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Baseline (n= 9, 2, 5, 4, 6, 5, 6) | 0.0974 mg/dL | Standard Deviation 0.06791 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 5 (n= 9, 2, 5, 4, 6, 5, 6) | -0.0352 mg/dL | Standard Deviation 0.03847 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 11 (n= 9, 2, 5, 3, 6, 4, 4) | -0.0186 mg/dL | Standard Deviation 0.07315 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Baseline (n= 9, 2, 5, 4, 6, 5, 6) | 0.0815 mg/dL | Standard Deviation 0.08556 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 10 (n= 9, 2, 5, 3, 6, 4, 4) | 0.0015 mg/dL | Standard Deviation 0.00778 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 28 (n= 9, 2, 5, 3, 6, 4, 4) | 0.0790 mg/dL | Standard Deviation 0.0891 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 2 (n= 9, 2, 5, 4, 6, 5, 6) | -0.0205 mg/dL | Standard Deviation 0.00071 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 11 (n= 9, 2, 5, 3, 6, 4, 4) | -0.0040 mg/dL | Standard Deviation 0.0099 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 5 (n= 9, 2, 5, 4, 6, 5, 6) | -0.0050 mg/dL | Standard Deviation 0.02263 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 11 (n= 9, 2, 5, 3, 6, 4, 4) | -0.1002 mg/dL | Standard Deviation 0.11675 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 5 (n= 9, 2, 5, 4, 6, 5, 6) | -0.0972 mg/dL | Standard Deviation 0.11656 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 28 (n= 9, 2, 5, 3, 6, 4, 4) | -0.0352 mg/dL | Standard Deviation 0.15033 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 10 (n= 9, 2, 5, 3, 6, 4, 4) | -0.1002 mg/dL | Standard Deviation 0.11675 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Baseline (n= 9, 2, 5, 4, 6, 5, 6) | 0.1002 mg/dL | Standard Deviation 0.11675 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 2 (n= 9, 2, 5, 4, 6, 5, 6) | -0.0670 mg/dL | Standard Deviation 0.08196 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 11 (n= 9, 2, 5, 3, 6, 4, 4) | -0.0870 mg/dL | Standard Deviation 0.00819 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Baseline (n= 9, 2, 5, 4, 6, 5, 6) | 0.0983 mg/dL | Standard Deviation 0.03734 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 2 (n= 9, 2, 5, 4, 6, 5, 6) | -0.0408 mg/dL | Standard Deviation 0.03052 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 5 (n= 9, 2, 5, 4, 6, 5, 6) | -0.0753 mg/dL | Standard Deviation 0.02269 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 10 (n= 9, 2, 5, 3, 6, 4, 4) | -0.0903 mg/dL | Standard Deviation 0.00961 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 28 (n= 9, 2, 5, 3, 6, 4, 4) | 0.0023 mg/dL | Standard Deviation 0.06001 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 10 (n= 9, 2, 5, 3, 6, 4, 4) | -0.0467 mg/dL | Standard Deviation 0.02881 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 2 (n= 9, 2, 5, 4, 6, 5, 6) | -0.0212 mg/dL | Standard Deviation 0.01712 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 11 (n= 9, 2, 5, 3, 6, 4, 4) | -0.0435 mg/dL | Standard Deviation 0.02849 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 28 (n= 9, 2, 5, 3, 6, 4, 4) | 0.0223 mg/dL | Standard Deviation 0.01556 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 5 (n= 9, 2, 5, 4, 6, 5, 6) | -0.0435 mg/dL | Standard Deviation 0.02202 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Baseline (n= 9, 2, 5, 4, 6, 5, 6) | 0.0505 mg/dL | Standard Deviation 0.02799 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 5 (n= 9, 2, 5, 4, 6, 5, 6) | -0.0596 mg/dL | Standard Deviation 0.03345 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 10 (n= 9, 2, 5, 3, 6, 4, 4) | -0.0618 mg/dL | Standard Deviation 0.01445 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 2 (n= 9, 2, 5, 4, 6, 5, 6) | -0.0298 mg/dL | Standard Deviation 0.01743 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 11 (n= 9, 2, 5, 3, 6, 4, 4) | -0.0615 mg/dL | Standard Deviation 0.0133 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Baseline (n= 9, 2, 5, 4, 6, 5, 6) | 0.0746 mg/dL | Standard Deviation 0.02523 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 28 (n= 9, 2, 5, 3, 6, 4, 4) | -0.0275 mg/dL | Standard Deviation 0.04086 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 5 (n= 9, 2, 5, 4, 6, 5, 6) | -0.1078 mg/dL | Standard Deviation 0.05948 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 2 (n= 9, 2, 5, 4, 6, 5, 6) | -0.0307 mg/dL | Standard Deviation 0.08168 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 28 (n= 9, 2, 5, 3, 6, 4, 4) | 1.1255 mg/dL | Standard Deviation 1.63253 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 10 (n= 9, 2, 5, 3, 6, 4, 4) | -0.1838 mg/dL | Standard Deviation 0.04529 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Change at Day 11 (n= 9, 2, 5, 3, 6, 4, 4) | -0.1878 mg/dL | Standard Deviation 0.04136 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28 | Baseline (n= 9, 2, 5, 4, 6, 5, 6) | 0.1902 mg/dL | Standard Deviation 0.06394 |
Secondary
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28
Serum samples for IP-10 were analyzed using a validated analytical assay. LLOQ for IP-10 was 10 pg/mL.
Time frame: Baseline, Day 2, 5, 10, 11, 28
Population: PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 28 (n =9, 2, 5, 3, 6, 4, 4) | -14.59 pg/mL | Standard Deviation 21.736 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 2 (n =9, 2, 5, 4, 6, 5, 6) | 5.66 pg/mL | Standard Deviation 13.421 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4) | -1.92 pg/mL | Standard Deviation 24.123 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 114.04 pg/mL | Standard Deviation 70.658 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 5 (n =9, 2, 5, 4, 6, 5, 6) | 4.33 pg/mL | Standard Deviation 12.213 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 11 (n =9, 2, 5, 3, 6, 4, 4) | 11.01 pg/mL | Standard Deviation 19.008 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 85.50 pg/mL | Standard Deviation 13.011 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4) | 4.75 pg/mL | Standard Deviation 9.687 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 28 (n =9, 2, 5, 3, 6, 4, 4) | 2.85 pg/mL | Standard Deviation 11.102 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 2 (n =9, 2, 5, 4, 6, 5, 6) | 2.00 pg/mL | Standard Deviation 13.294 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 11 (n =9, 2, 5, 3, 6, 4, 4) | 1.85 pg/mL | Standard Deviation 0.778 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 5 (n =9, 2, 5, 4, 6, 5, 6) | -3.25 pg/mL | Standard Deviation 13.506 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 11 (n =9, 2, 5, 3, 6, 4, 4) | -37.56 pg/mL | Standard Deviation 47.031 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 5 (n =9, 2, 5, 4, 6, 5, 6) | -42.12 pg/mL | Standard Deviation 48.25 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 28 (n =9, 2, 5, 3, 6, 4, 4) | -11.76 pg/mL | Standard Deviation 51.955 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4) | -40.10 pg/mL | Standard Deviation 43.129 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 101.12 pg/mL | Standard Deviation 56.853 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 2 (n =9, 2, 5, 4, 6, 5, 6) | -20.14 pg/mL | Standard Deviation 41.966 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 11 (n =9, 2, 5, 3, 6, 4, 4) | -102.53 pg/mL | Standard Deviation 131.223 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 142.23 pg/mL | Standard Deviation 165.924 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 2 (n =9, 2, 5, 4, 6, 5, 6) | -23.60 pg/mL | Standard Deviation 82.888 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 5 (n =9, 2, 5, 4, 6, 5, 6) | -53.40 pg/mL | Standard Deviation 125.815 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4) | -96.67 pg/mL | Standard Deviation 134.176 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 28 (n =9, 2, 5, 3, 6, 4, 4) | -62.07 pg/mL | Standard Deviation 94.378 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4) | -57.22 pg/mL | Standard Deviation 9.321 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 2 (n =9, 2, 5, 4, 6, 5, 6) | -47.52 pg/mL | Standard Deviation 19.664 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 11 (n =9, 2, 5, 3, 6, 4, 4) | -37.95 pg/mL | Standard Deviation 24.957 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 28 (n =9, 2, 5, 3, 6, 4, 4) | 8.48 pg/mL | Standard Deviation 23.01 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 5 (n =9, 2, 5, 4, 6, 5, 6) | -55.80 pg/mL | Standard Deviation 15.273 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 106.43 pg/mL | Standard Deviation 28.244 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 5 (n =9, 2, 5, 4, 6, 5, 6) | -71.40 pg/mL | Standard Deviation 11.857 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4) | -70.50 pg/mL | Standard Deviation 14.007 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 2 (n =9, 2, 5, 4, 6, 5, 6) | -60.64 pg/mL | Standard Deviation 16.913 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 11 (n =9, 2, 5, 3, 6, 4, 4) | -54.25 pg/mL | Standard Deviation 23.972 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 121.60 pg/mL | Standard Deviation 20.959 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 28 (n =9, 2, 5, 3, 6, 4, 4) | 18.30 pg/mL | Standard Deviation 34.748 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 5 (n =9, 2, 5, 4, 6, 5, 6) | -80.65 pg/mL | Standard Deviation 66.445 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 2 (n =9, 2, 5, 4, 6, 5, 6) | -67.73 pg/mL | Standard Deviation 35.998 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 28 (n =9, 2, 5, 3, 6, 4, 4) | -47.15 pg/mL | Standard Deviation 89.356 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4) | -106.40 pg/mL | Standard Deviation 60.163 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Change at Day 11 (n =9, 2, 5, 3, 6, 4, 4) | -112.20 pg/mL | Standard Deviation 60.459 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 10, 11, 28 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 135.42 pg/mL | Standard Deviation 57.855 |
Secondary
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28
Time frame: Baseline, Day 4, 8, 10, 11, 14, 28
Population: PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4) | 0.156 cells/mm^3 | Standard Deviation 0.586 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 2.584 cells/mm^3 | Standard Deviation 0.8858 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 28 (n =9, 2, 5, 3, 6, 4, 4) | 0.030 cells/mm^3 | Standard Deviation 0.4649 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 4 (n =9, 2, 5, 4, 6, 5, 6) | 0.099 cells/mm^3 | Standard Deviation 0.4191 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 14 (n =9, 2, 5, 3, 6, 4, 4) | -0.020 cells/mm^3 | Standard Deviation 0.5471 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 8 (n =9, 2, 5, 4, 6, 4, 5) | 0.239 cells/mm^3 | Standard Deviation 0.5725 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 11 (n =9, 2, 5, 3, 6, 4, 4) | 0.158 cells/mm^3 | Standard Deviation 0.4996 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 2.340 cells/mm^3 | Standard Deviation 0.297 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 4 (n =9, 2, 5, 4, 6, 5, 6) | 0.060 cells/mm^3 | Standard Deviation 0.0283 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 14 (n =9, 2, 5, 3, 6, 4, 4) | 0.385 cells/mm^3 | Standard Deviation 0.8273 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 11 (n =9, 2, 5, 3, 6, 4, 4) | 0.400 cells/mm^3 | Standard Deviation 1.2021 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4) | 0.635 cells/mm^3 | Standard Deviation 1.0394 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 8 (n =9, 2, 5, 4, 6, 4, 5) | 0.635 cells/mm^3 | Standard Deviation 1.1526 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 28 (n =9, 2, 5, 3, 6, 4, 4) | 0.130 cells/mm^3 | Standard Deviation 0.4525 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 8 (n =9, 2, 5, 4, 6, 4, 5) | -0.296 cells/mm^3 | Standard Deviation 0.7032 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 28 (n =9, 2, 5, 3, 6, 4, 4) | -0.012 cells/mm^3 | Standard Deviation 1.1401 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 4 (n =9, 2, 5, 4, 6, 5, 6) | -0.242 cells/mm^3 | Standard Deviation 1.1533 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 2.676 cells/mm^3 | Standard Deviation 0.6726 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 14 (n =9, 2, 5, 3, 6, 4, 4) | -0.060 cells/mm^3 | Standard Deviation 0.8663 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4) | -0.340 cells/mm^3 | Standard Deviation 0.8602 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 11 (n =9, 2, 5, 3, 6, 4, 4) | -0.382 cells/mm^3 | Standard Deviation 0.8244 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4) | 0.327 cells/mm^3 | Standard Deviation 0.8228 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 2.770 cells/mm^3 | Standard Deviation 0.4907 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 4 (n =9, 2, 5, 4, 6, 5, 6) | -0.215 cells/mm^3 | Standard Deviation 0.6376 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 8 (n =9, 2, 5, 4, 6, 4, 5) | -0.178 cells/mm^3 | Standard Deviation 0.516 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 11 (n =9, 2, 5, 3, 6, 4, 4) | 0.260 cells/mm^3 | Standard Deviation 0.7572 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 14 (n =9, 2, 5, 3, 6, 4, 4) | 0.650 cells/mm^3 | Standard Deviation 0.8543 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 28 (n =9, 2, 5, 3, 6, 4, 4) | 0.697 cells/mm^3 | Standard Deviation 0.0839 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 28 (n =9, 2, 5, 3, 6, 4, 4) | -0.055 cells/mm^3 | Standard Deviation 0.4578 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 2.710 cells/mm^3 | Standard Deviation 1.0372 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4) | -1.012 cells/mm^3 | Standard Deviation 0.5365 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 8 (n =9, 2, 5, 4, 6, 4, 5) | -0.793 cells/mm^3 | Standard Deviation 0.572 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 4 (n =9, 2, 5, 4, 6, 5, 6) | -0.295 cells/mm^3 | Standard Deviation 0.8 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 14 (n =9, 2, 5, 3, 6, 4, 4) | 0.232 cells/mm^3 | Standard Deviation 0.4395 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 11 (n =9, 2, 5, 3, 6, 4, 4) | -0.280 cells/mm^3 | Standard Deviation 0.9159 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 28 (n =9, 2, 5, 3, 6, 4, 4) | 0.050 cells/mm^3 | Standard Deviation 0.6249 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 2.690 cells/mm^3 | Standard Deviation 0.9337 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 4 (n =9, 2, 5, 4, 6, 5, 6) | -0.980 cells/mm^3 | Standard Deviation 0.3726 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 11 (n =9, 2, 5, 3, 6, 4, 4) | -0.248 cells/mm^3 | Standard Deviation 0.3976 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 14 (n =9, 2, 5, 3, 6, 4, 4) | 0.228 cells/mm^3 | Standard Deviation 0.3377 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4) | -1.168 cells/mm^3 | Standard Deviation 0.4197 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 8 (n =9, 2, 5, 4, 6, 4, 5) | -0.913 cells/mm^3 | Standard Deviation 0.4039 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4) | -2.125 cells/mm^3 | Standard Deviation 1.2878 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 11 (n =9, 2, 5, 3, 6, 4, 4) | -2.010 cells/mm^3 | Standard Deviation 1.3075 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 4 (n =9, 2, 5, 4, 6, 5, 6) | -0.902 cells/mm^3 | Standard Deviation 2.068 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 14 (n =9, 2, 5, 3, 6, 4, 4) | 0.290 cells/mm^3 | Standard Deviation 1.0943 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 3.217 cells/mm^3 | Standard Deviation 0.9677 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 28 (n =9, 2, 5, 3, 6, 4, 4) | 0.298 cells/mm^3 | Standard Deviation 0.3777 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | Change at Day 8 (n =9, 2, 5, 4, 6, 4, 5) | -1.702 cells/mm^3 | Standard Deviation 1.3292 |
Secondary
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28
Time frame: Baseline, Day 4, 8, 10, 11, 14, 28
Population: PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4) | -0.19 cells/mm^3 | Standard Deviation 0.398 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 1.26 cells/mm^3 | Standard Deviation 0.49 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 28 (n =9, 2, 5, 3, 6, 4, 4) | 0.11 cells/mm^3 | Standard Deviation 0.431 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 4 (n =9, 2, 5, 4, 6, 5, 6) | -0.03 cells/mm^3 | Standard Deviation 0.212 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 14 (n =9, 2, 5, 3, 6, 4, 4) | -0.12 cells/mm^3 | Standard Deviation 0.393 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 8 (n =9, 2, 5, 4, 6, 4, 5) | -0.11 cells/mm^3 | Standard Deviation 0.285 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 11 (n =9, 2, 5, 3, 6, 4, 4) | -0.13 cells/mm^3 | Standard Deviation 0.343 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 0.85 cells/mm^3 | Standard Deviation 0.212 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 4 (n =9, 2, 5, 4, 6, 5, 6) | 0.05 cells/mm^3 | Standard Deviation 0.071 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 14 (n =9, 2, 5, 3, 6, 4, 4) | 0.05 cells/mm^3 | Standard Deviation 0.495 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 11 (n =9, 2, 5, 3, 6, 4, 4) | 0.30 cells/mm^3 | Standard Deviation 0.424 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4) | 0.20 cells/mm^3 | Standard Deviation 0.283 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 8 (n =9, 2, 5, 4, 6, 4, 5) | 0.30 cells/mm^3 | Standard Deviation 0.283 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 28 (n =9, 2, 5, 3, 6, 4, 4) | -0.05 cells/mm^3 | Standard Deviation 0.212 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 8 (n =9, 2, 5, 4, 6, 4, 5) | -0.20 cells/mm^3 | Standard Deviation 0.1 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 28 (n =9, 2, 5, 3, 6, 4, 4) | 0.22 cells/mm^3 | Standard Deviation 0.277 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 4 (n =9, 2, 5, 4, 6, 5, 6) | -0.10 cells/mm^3 | Standard Deviation 0.071 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 1.22 cells/mm^3 | Standard Deviation 0.363 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 14 (n =9, 2, 5, 3, 6, 4, 4) | -0.22 cells/mm^3 | Standard Deviation 0.11 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4) | -0.24 cells/mm^3 | Standard Deviation 0.089 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 11 (n =9, 2, 5, 3, 6, 4, 4) | -0.34 cells/mm^3 | Standard Deviation 0.089 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4) | -0.07 cells/mm^3 | Standard Deviation 0.231 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 1.03 cells/mm^3 | Standard Deviation 0.35 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 4 (n =9, 2, 5, 4, 6, 5, 6) | 0.05 cells/mm^3 | Standard Deviation 0.129 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 8 (n =9, 2, 5, 4, 6, 4, 5) | -0.13 cells/mm^3 | Standard Deviation 0.25 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 11 (n =9, 2, 5, 3, 6, 4, 4) | -0.23 cells/mm^3 | Standard Deviation 0.115 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 14 (n =9, 2, 5, 3, 6, 4, 4) | 0.03 cells/mm^3 | Standard Deviation 0.058 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 28 (n =9, 2, 5, 3, 6, 4, 4) | 0.30 cells/mm^3 | Standard Deviation 0.346 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 28 (n =9, 2, 5, 3, 6, 4, 4) | 0.65 cells/mm^3 | Standard Deviation 0.619 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 1.40 cells/mm^3 | Standard Deviation 0.41 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4) | -0.70 cells/mm^3 | Standard Deviation 0.352 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 8 (n =9, 2, 5, 4, 6, 4, 5) | -0.60 cells/mm^3 | Standard Deviation 0.21 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 4 (n =9, 2, 5, 4, 6, 5, 6) | -0.18 cells/mm^3 | Standard Deviation 0.306 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 14 (n =9, 2, 5, 3, 6, 4, 4) | -0.60 cells/mm^3 | Standard Deviation 0.297 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 11 (n =9, 2, 5, 3, 6, 4, 4) | -0.72 cells/mm^3 | Standard Deviation 0.354 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 28 (n =9, 2, 5, 3, 6, 4, 4) | 0.18 cells/mm^3 | Standard Deviation 0.189 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 2.26 cells/mm^3 | Standard Deviation 0.55 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 4 (n =9, 2, 5, 4, 6, 5, 6) | -0.54 cells/mm^3 | Standard Deviation 0.241 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 11 (n =9, 2, 5, 3, 6, 4, 4) | -1.43 cells/mm^3 | Standard Deviation 0.499 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 14 (n =9, 2, 5, 3, 6, 4, 4) | -1.10 cells/mm^3 | Standard Deviation 0.408 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4) | -1.48 cells/mm^3 | Standard Deviation 0.403 |
| PF-06700841: 100 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 8 (n =9, 2, 5, 4, 6, 4, 5) | -1.28 cells/mm^3 | Standard Deviation 0.395 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 10 (n =9, 2, 5, 3, 6, 4, 4) | -0.93 cells/mm^3 | Standard Deviation 0.206 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 11 (n =9, 2, 5, 3, 6, 4, 4) | -0.93 cells/mm^3 | Standard Deviation 0.33 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 4 (n =9, 2, 5, 4, 6, 5, 6) | -0.32 cells/mm^3 | Standard Deviation 0.223 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 14 (n =9, 2, 5, 3, 6, 4, 4) | -0.90 cells/mm^3 | Standard Deviation 0.183 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Baseline (n =9, 2, 5, 4, 6, 5, 6) | 1.38 cells/mm^3 | Standard Deviation 0.286 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 28 (n =9, 2, 5, 3, 6, 4, 4) | 0.33 cells/mm^3 | Standard Deviation 0.479 |
| PF-06700841: 200 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | Change at Day 8 (n =9, 2, 5, 4, 6, 4, 5) | -0.90 cells/mm^3 | Standard Deviation 0.187 |
Secondary
Multiple Ascending Dose (MAD) Cohort: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau[dn]) of PF-06700841
Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort. AUCtau(dn) was calculated by dividing AUCtau by the exact dose of of PF-06700841 (in mg) administered to a participant.
Time frame: pre-dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10
Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo Once Daily and Twice Daily: MAD Cohort arms.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau[dn]) of PF-06700841 | 42.28 [ng*hr/mL]/mg | Geometric Coefficient of Variation 41 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau[dn]) of PF-06700841 | 62.68 [ng*hr/mL]/mg | Geometric Coefficient of Variation 51 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau[dn]) of PF-06700841 | 60.89 [ng*hr/mL]/mg | Geometric Coefficient of Variation 38 |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau[dn]) of PF-06700841 | 71.15 [ng*hr/mL]/mg | Geometric Coefficient of Variation 36 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau[dn]) of PF-06700841 | 92.30 [ng*hr/mL]/mg | Geometric Coefficient of Variation 16 |
Secondary
Multiple Ascending Dose (MAD) Cohort: Percentage of Dose of PF-06700841 Recovered Unchanged in the Urine Over the Time Interval Tau (Aetau%)
Aetau% was calculated as: 100\*Aetau/dose. Aetau is the amount of drug recovered unchanged in urine during the dosing interval (tau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort.
Time frame: 0-24 hours on Day 10
Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo Once Daily and Twice Daily: MAD Cohort arms.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Percentage of Dose of PF-06700841 Recovered Unchanged in the Urine Over the Time Interval Tau (Aetau%) | 11.09 percentage of dose recovered | Geometric Coefficient of Variation 45 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Percentage of Dose of PF-06700841 Recovered Unchanged in the Urine Over the Time Interval Tau (Aetau%) | 9.332 percentage of dose recovered | Geometric Coefficient of Variation 57 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Percentage of Dose of PF-06700841 Recovered Unchanged in the Urine Over the Time Interval Tau (Aetau%) | NA percentage of dose recovered | — |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Percentage of Dose of PF-06700841 Recovered Unchanged in the Urine Over the Time Interval Tau (Aetau%) | 15.54 percentage of dose recovered | Geometric Coefficient of Variation 57 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Percentage of Dose of PF-06700841 Recovered Unchanged in the Urine Over the Time Interval Tau (Aetau%) | 8.910 percentage of dose recovered | Geometric Coefficient of Variation 44 |
Secondary
Multiple Ascending Dose (MAD) Cohort: Renal Clearance
Renal clearance was calculated as amount of drug recovered unchanged in urine during the dosing interval tau (Aetau) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCtau), where dosing interval was 24 hours for MAD once daily cohorts, 12 hours for MAD twice daily cohort.
Time frame: 0-24 hours on Day 10
Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo Once Daily and Twice Daily: MAD Cohort arms.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Renal Clearance | 2.619 Liter per hour | Geometric Coefficient of Variation 18 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Renal Clearance | 1.486 Liter per hour | Geometric Coefficient of Variation 15 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Renal Clearance | NA Liter per hour | — |
| PF-06700841: 10 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Renal Clearance | 2.179 Liter per hour | Geometric Coefficient of Variation 31 |
| PF-06700841: 30 mg SAD Cohort | Multiple Ascending Dose (MAD) Cohort: Renal Clearance | 0.9629 Liter per hour | Geometric Coefficient of Variation 58 |
Secondary
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56
Serum samples for hsCRP were analyzed using a validated analytical assay. Reference range for measurement of CRP was 0.015 to 2.0 mg/dL. LLOQ for hsCRP was 0.03 mg/dL and limit of detection was 0.015 mg/dL.
Time frame: Baseline, Day 2, 5 ,7,14, 21, 28, 29, 35, 56
Population: PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Baseline (n =9, 14, 7) | 1.0699 mg/dL | Standard Deviation 1.39179 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Change at Day 2 (n =9, 14, 7) | -0.1096 mg/dL | Standard Deviation 0.2537 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Change at Day 5 (n =9, 14, 7) | 0.0204 mg/dL | Standard Deviation 0.51424 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Change at Day 7 (n =9, 12, 7) | 0.1958 mg/dL | Standard Deviation 0.85725 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Change at Day 14 (n =9, 10, 6) | 0.4118 mg/dL | Standard Deviation 1.1919 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Change at Day 21 (n =9, 9, 5) | -0.1397 mg/dL | Standard Deviation 0.46958 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Change at Day 28 (n =8, 7, 5) | -0.4075 mg/dL | Standard Deviation 0.37814 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Change at Day 29 (n =8, 7, 5) | -0.6113 mg/dL | Standard Deviation 0.79373 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Change at Day 35 (n =8, 6, 5) | -0.5945 mg/dL | Standard Deviation 0.78042 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Change at Day 56 (n =7, 6, 4) | -0.3407 mg/dL | Standard Deviation 0.4528 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Change at Day 35 (n =8, 6, 5) | -0.2533 mg/dL | Standard Deviation 0.79446 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Baseline (n =9, 14, 7) | 0.5694 mg/dL | Standard Deviation 1.11752 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Change at Day 21 (n =9, 9, 5) | -0.3067 mg/dL | Standard Deviation 0.61035 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Change at Day 14 (n =9, 10, 6) | -0.1910 mg/dL | Standard Deviation 0.65215 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Change at Day 2 (n =9, 14, 7) | -0.3408 mg/dL | Standard Deviation 0.86901 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Change at Day 56 (n =7, 6, 4) | -0.2662 mg/dL | Standard Deviation 0.78307 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Change at Day 29 (n =8, 7, 5) | -0.3533 mg/dL | Standard Deviation 0.69589 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Change at Day 5 (n =9, 14, 7) | -0.2413 mg/dL | Standard Deviation 1.45363 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Change at Day 28 (n =8, 7, 5) | -0.3549 mg/dL | Standard Deviation 0.69576 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Change at Day 7 (n =9, 12, 7) | -0.1573 mg/dL | Standard Deviation 1.9064 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Change at Day 29 (n =8, 7, 5) | -0.2626 mg/dL | Standard Deviation 0.34387 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Change at Day 7 (n =9, 12, 7) | -0.1983 mg/dL | Standard Deviation 0.31021 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Change at Day 14 (n =9, 10, 6) | -0.2582 mg/dL | Standard Deviation 0.33762 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Change at Day 21 (n =9, 9, 5) | -0.2716 mg/dL | Standard Deviation 0.38954 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Change at Day 35 (n =8, 6, 5) | 0.7546 mg/dL | Standard Deviation 1.07215 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Change at Day 28 (n =8, 7, 5) | -0.2670 mg/dL | Standard Deviation 0.37674 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Baseline (n =9, 14, 7) | 0.3143 mg/dL | Standard Deviation 0.34167 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Change at Day 56 (n =7, 6, 4) | 0.2533 mg/dL | Standard Deviation 0.82107 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Change at Day 2 (n =9, 14, 7) | -0.0189 mg/dL | Standard Deviation 0.1418 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 7, 14, 21, 28, 29, 35 and 56 | Change at Day 5 (n =9, 14, 7) | -0.2119 mg/dL | Standard Deviation 0.27245 |
Secondary
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56
Serum samples for IP-10 were analyzed using a validated analytical assay. Lower limit of quantification (LLOQ) for IP-10 was 10 pg/mL.
Time frame: Baseline, Day 2, 5, 7, 14, 21, 28, 29, 35, 56
Population: PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Baseline (n =9, 14, 7) | 302.00 pg/mL | Standard Deviation 281.552 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Change at Day 2 (n =9, 14, 7) | 53.44 pg/mL | Standard Deviation 214.334 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Change at Day 5 (n =9, 14, 7) | -21.63 pg/mL | Standard Deviation 142.195 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Change at Day 7 (n =9, 12, 7) | -25.71 pg/mL | Standard Deviation 133.51 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Change at Day 14 (n =9, 10, 6) | -69.91 pg/mL | Standard Deviation 106.951 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Change at Day 21 (n =9, 9, 5) | -42.87 pg/mL | Standard Deviation 122.986 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Change at Day 28 (n =8, 7, 5) | -1.0 pg/mL | Standard Deviation 31.351 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Change at Day 29 (n =8, 7, 5) | -22.20 pg/mL | Standard Deviation 95.93 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Change at Day 35 (n =8, 6, 5) | -69.54 pg/mL | Standard Deviation 124.165 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Change at Day 56 (n =7, 6, 4) | -31.71 pg/mL | Standard Deviation 67.158 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Change at Day 35 (n =8, 6, 5) | 10.45 pg/mL | Standard Deviation 37.86 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Baseline (n =9, 14, 7) | 127.58 pg/mL | Standard Deviation 45.829 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Change at Day 21 (n =9, 9, 5) | -51.47 pg/mL | Standard Deviation 28.094 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Change at Day 14 (n =9, 10, 6) | -52.06 pg/mL | Standard Deviation 24.663 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Change at Day 2 (n =9, 14, 7) | -8.51 pg/mL | Standard Deviation 34.704 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Change at Day 56 (n =7, 6, 4) | 16.18 pg/mL | Standard Deviation 19.348 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Change at Day 29 (n =8, 7, 5) | -37.50 pg/mL | Standard Deviation 31.849 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Change at Day 5 (n =9, 14, 7) | -33.93 pg/mL | Standard Deviation 33.465 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Change at Day 28 (n =8, 7, 5) | -46.19 pg/mL | Standard Deviation 35.893 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Change at Day 7 (n =9, 12, 7) | -31.31 pg/mL | Standard Deviation 32.203 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Change at Day 29 (n =8, 7, 5) | -49.34 pg/mL | Standard Deviation 14.306 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Change at Day 7 (n =9, 12, 7) | -52.50 pg/mL | Standard Deviation 42.216 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Change at Day 14 (n =9, 10, 6) | -68.55 pg/mL | Standard Deviation 28.524 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Change at Day 21 (n =9, 9, 5) | -46.64 pg/mL | Standard Deviation 27.34 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Change at Day 35 (n =8, 6, 5) | 110.68 pg/mL | Standard Deviation 108.041 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Change at Day 28 (n =8, 7, 5) | -53.36 pg/mL | Standard Deviation 19.771 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Baseline (n =9, 14, 7) | 123.09 pg/mL | Standard Deviation 22.244 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Change at Day 56 (n =7, 6, 4) | 167.85 pg/mL | Standard Deviation 201.78 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Change at Day 2 (n =9, 14, 7) | -49.57 pg/mL | Standard Deviation 35.759 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Interferon Gamma-Induced Protein 10 (IP-10) Concentration in Serum at Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | Change at Day 5 (n =9, 14, 7) | -49.01 pg/mL | Standard Deviation 35.998 |
Secondary
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56
Time frame: Baseline, Day 4, 6 ,8,10, 13, 14, 21, 28, 35, 42, 56
Population: PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Baseline (n =9, 14, 7) | 4.109 cells/mm^3 | Standard Deviation 1.4401 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 4 (n =9, 14, 7) | -0.402 cells/mm^3 | Standard Deviation 0.9308 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 6 (n =9, 14, 7) | -0.209 cells/mm^3 | Standard Deviation 1.2224 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 8 (n =9, 12, 7) | -0.473 cells/mm^3 | Standard Deviation 0.6962 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 10 (n =9, 10, 7) | -0.463 cells/mm^3 | Standard Deviation 0.7834 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 13 (n =9, 10, 6) | -0.654 cells/mm^3 | Standard Deviation 0.7847 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 14 (n =9, 10, 6) | -0.247 cells/mm^3 | Standard Deviation 0.9682 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 21 (n =9, 9, 5) | -0.762 cells/mm^3 | Standard Deviation 0.7389 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 28 (n =8, 7, 5) | -0.678 cells/mm^3 | Standard Deviation 0.6416 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 35 (n =8, 6, 5) | -0.081 cells/mm^3 | Standard Deviation 1.4496 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 42 (n =7, 6, 4) | -0.427 cells/mm^3 | Standard Deviation 0.6004 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 56 (n =7, 6, 4) | -0.036 cells/mm^3 | Standard Deviation 0.7864 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 56 (n =7, 6, 4) | -0.533 cells/mm^3 | Standard Deviation 1.3025 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Baseline (n =9, 14, 7) | 3.640 cells/mm^3 | Standard Deviation 1.4997 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 14 (n =9, 10, 6) | -0.146 cells/mm^3 | Standard Deviation 1.1226 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 28 (n =8, 7, 5) | -0.890 cells/mm^3 | Standard Deviation 0.9952 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 4 (n =9, 14, 7) | 0.006 cells/mm^3 | Standard Deviation 1.1696 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 13 (n =9, 10, 6) | -0.297 cells/mm^3 | Standard Deviation 1.2264 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 42 (n =7, 6, 4) | -0.677 cells/mm^3 | Standard Deviation 1.1209 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 6 (n =9, 14, 7) | -0.073 cells/mm^3 | Standard Deviation 0.8229 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 21 (n =9, 9, 5) | -0.638 cells/mm^3 | Standard Deviation 0.9404 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 10 (n =9, 10, 7) | 0.197 cells/mm^3 | Standard Deviation 1.1099 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 8 (n =9, 12, 7) | 0.013 cells/mm^3 | Standard Deviation 1.2572 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 35 (n =8, 6, 5) | -0.777 cells/mm^3 | Standard Deviation 1.1154 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 8 (n =9, 12, 7) | -0.973 cells/mm^3 | Standard Deviation 0.4394 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 10 (n =9, 10, 7) | -1.299 cells/mm^3 | Standard Deviation 0.6906 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 35 (n =8, 6, 5) | -1.008 cells/mm^3 | Standard Deviation 0.8082 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 13 (n =9, 10, 6) | -1.538 cells/mm^3 | Standard Deviation 0.9097 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 14 (n =9, 10, 6) | -1.465 cells/mm^3 | Standard Deviation 0.9517 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 21 (n =9, 9, 5) | -1.410 cells/mm^3 | Standard Deviation 1.2572 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 42 (n =7, 6, 4) | -1.050 cells/mm^3 | Standard Deviation 0.6868 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Baseline (n =9, 14, 7) | 3.909 cells/mm^3 | Standard Deviation 1.1841 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 4 (n =9, 14, 7) | 0.153 cells/mm^3 | Standard Deviation 0.7114 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 28 (n =8, 7, 5) | -1.450 cells/mm^3 | Standard Deviation 1.1195 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 6 (n =9, 14, 7) | -0.303 cells/mm^3 | Standard Deviation 0.6058 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Neutrophil Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 56 (n =7, 6, 4) | -0.493 cells/mm^3 | Standard Deviation 1.6373 |
Secondary
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56
Time frame: Baseline, Day 4, 6 ,8,10, 13, 14, 21, 28, 35, 42, 56
Population: PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Baseline (n =9, 14, 7) | 1.49 cells/mm^3 | Standard Deviation 0.355 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 4 (n =9, 14, 7) | -0.10 cells/mm^3 | Standard Deviation 0.3 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 6 (n =9, 14, 7) | -0.09 cells/mm^3 | Standard Deviation 0.392 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 8 (n =9, 12, 7) | -0.20 cells/mm^3 | Standard Deviation 0.43 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 10 (n =9, 10, 7) | -0.21 cells/mm^3 | Standard Deviation 0.355 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 13 (n =9, 10, 6) | -0.20 cells/mm^3 | Standard Deviation 0.354 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 14 (n =9, 10, 6) | -0.13 cells/mm^3 | Standard Deviation 0.371 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 21 (n =9, 9, 5) | -0.22 cells/mm^3 | Standard Deviation 0.393 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 28 (n =8, 7, 5) | -0.24 cells/mm^3 | Standard Deviation 0.487 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 35 (n =8, 6, 5) | 0.26 cells/mm^3 | Standard Deviation 0.498 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 42 (n =7, 6, 4) | 0.46 cells/mm^3 | Standard Deviation 0.431 |
| Placebo: SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 56 (n =7, 6, 4 | 0.13 cells/mm^3 | Standard Deviation 0.335 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 56 (n =7, 6, 4 | 0.07 cells/mm^3 | Standard Deviation 0.25 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Baseline (n =9, 14, 7) | 1.45 cells/mm^3 | Standard Deviation 0.285 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 14 (n =9, 10, 6) | -0.34 cells/mm^3 | Standard Deviation 0.392 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 28 (n =8, 7, 5) | -0.36 cells/mm^3 | Standard Deviation 0.264 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 4 (n =9, 14, 7) | -0.09 cells/mm^3 | Standard Deviation 0.207 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 13 (n =9, 10, 6) | -0.41 cells/mm^3 | Standard Deviation 0.373 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 42 (n =7, 6, 4) | 0.33 cells/mm^3 | Standard Deviation 0.427 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 6 (n =9, 14, 7) | -0.16 cells/mm^3 | Standard Deviation 0.25 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 21 (n =9, 9, 5) | -0.27 cells/mm^3 | Standard Deviation 0.43 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 10 (n =9, 10, 7) | -0.35 cells/mm^3 | Standard Deviation 0.295 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 8 (n =9, 12, 7) | -0.21 cells/mm^3 | Standard Deviation 0.243 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 35 (n =8, 6, 5) | -0.03 cells/mm^3 | Standard Deviation 0.163 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 8 (n =9, 12, 7) | -0.59 cells/mm^3 | Standard Deviation 0.353 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 10 (n =9, 10, 7) | -0.70 cells/mm^3 | Standard Deviation 0.361 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 35 (n =8, 6, 5) | 0.22 cells/mm^3 | Standard Deviation 0.228 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 13 (n =9, 10, 6) | -0.75 cells/mm^3 | Standard Deviation 0.459 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 14 (n =9, 10, 6) | -0.82 cells/mm^3 | Standard Deviation 0.462 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 21 (n =9, 9, 5) | -0.66 cells/mm^3 | Standard Deviation 0.27 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 42 (n =7, 6, 4) | 1.35 cells/mm^3 | Standard Deviation 0.551 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Baseline (n =9, 14, 7) | 1.31 cells/mm^3 | Standard Deviation 0.393 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 4 (n =9, 14, 7) | -0.13 cells/mm^3 | Standard Deviation 0.281 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 28 (n =8, 7, 5) | -0.60 cells/mm^3 | Standard Deviation 0.255 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 6 (n =9, 14, 7) | -0.27 cells/mm^3 | Standard Deviation 0.373 |
| PF--06700841: 3 mg SAD Cohort | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 6, 8, 10, 13, 14, 21, 28, 35, 42 and 56 | Change at Day 56 (n =7, 6, 4 | 0.50 cells/mm^3 | Standard Deviation 0.183 |
Secondary
Single Ascending Dose (SAD) Cohort: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06700841
Area under the plasma concentration time-curve from time zero to the time of last measured concentration (AUClast).
Time frame: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1
Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort arm
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06700841 | 17.71 ng*hr/mL | Geometric Coefficient of Variation 114 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06700841 | 79.18 ng*hr/mL | Geometric Coefficient of Variation 239 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06700841 | 340.4 ng*hr/mL | Geometric Coefficient of Variation 30 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06700841 | 1431 ng*hr/mL | Geometric Coefficient of Variation 65 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06700841 | 5041 ng*hr/mL | Geometric Coefficient of Variation 59 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06700841 | 18400 ng*hr/mL | Geometric Coefficient of Variation 46 |
Secondary
Single Ascending Dose (SAD) Cohort: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06700841
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).
Time frame: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1
Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort arm
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06700841 | NA ng*hr/mL | — |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06700841 | 145.8 ng*hr/mL | Geometric Coefficient of Variation 61 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06700841 | 353.8 ng*hr/mL | Geometric Coefficient of Variation 31 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06700841 | 1439 ng*hr/mL | Geometric Coefficient of Variation 65 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06700841 | 4797 ng*hr/mL | Geometric Coefficient of Variation 62 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06700841 | 18410 ng*hr/mL | Geometric Coefficient of Variation 46 |
Secondary
Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8
Time frame: Baseline, Day 2, 5, 8
Population: PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8 | Baseline (n =13, 7, 6, 6, 6, 8, 8) | 2.988 cells per millimeter cube (cells/mm^3) | Standard Deviation 1.209 |
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8 | Change at Day 2 (n =13, 7, 6, 6, 6, 8, 8) | 0.096 cells per millimeter cube (cells/mm^3) | Standard Deviation 0.7459 |
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8 | Change at Day 5 (n =13, 6, 6, 6, 5, 8, 8) | 0.047 cells per millimeter cube (cells/mm^3) | Standard Deviation 0.8048 |
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8 | Change at Day 8 (n =12, 5, 6, 6, 5, 8, 8) | -0.245 cells per millimeter cube (cells/mm^3) | Standard Deviation 0.7834 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8 | Change at Day 8 (n =12, 5, 6, 6, 5, 8, 8) | 0.196 cells per millimeter cube (cells/mm^3) | Standard Deviation 0.1674 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8 | Change at Day 5 (n =13, 6, 6, 6, 5, 8, 8) | 0.280 cells per millimeter cube (cells/mm^3) | Standard Deviation 0.5187 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8 | Baseline (n =13, 7, 6, 6, 6, 8, 8) | 2.433 cells per millimeter cube (cells/mm^3) | Standard Deviation 1.0574 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8 | Change at Day 2 (n =13, 7, 6, 6, 6, 8, 8) | 0.340 cells per millimeter cube (cells/mm^3) | Standard Deviation 0.6643 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8 | Change at Day 5 (n =13, 6, 6, 6, 5, 8, 8) | -0.162 cells per millimeter cube (cells/mm^3) | Standard Deviation 1.1032 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8 | Change at Day 2 (n =13, 7, 6, 6, 6, 8, 8) | 0.377 cells per millimeter cube (cells/mm^3) | Standard Deviation 0.7133 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8 | Baseline (n =13, 7, 6, 6, 6, 8, 8) | 3.097 cells per millimeter cube (cells/mm^3) | Standard Deviation 1.1903 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8 | Change at Day 8 (n =12, 5, 6, 6, 5, 8, 8) | 0.017 cells per millimeter cube (cells/mm^3) | Standard Deviation 1.1173 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8 | Baseline (n =13, 7, 6, 6, 6, 8, 8) | 2.500 cells per millimeter cube (cells/mm^3) | Standard Deviation 0.6782 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8 | Change at Day 2 (n =13, 7, 6, 6, 6, 8, 8) | 0.285 cells per millimeter cube (cells/mm^3) | Standard Deviation 0.3214 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8 | Change at Day 5 (n =13, 6, 6, 6, 5, 8, 8) | -0.170 cells per millimeter cube (cells/mm^3) | Standard Deviation 0.2265 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8 | Change at Day 8 (n =12, 5, 6, 6, 5, 8, 8) | -0.293 cells per millimeter cube (cells/mm^3) | Standard Deviation 0.31 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8 | Baseline (n =13, 7, 6, 6, 6, 8, 8) | 3.048 cells per millimeter cube (cells/mm^3) | Standard Deviation 0.7552 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8 | Change at Day 8 (n =12, 5, 6, 6, 5, 8, 8) | -0.058 cells per millimeter cube (cells/mm^3) | Standard Deviation 0.9051 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8 | Change at Day 2 (n =13, 7, 6, 6, 6, 8, 8) | 0.240 cells per millimeter cube (cells/mm^3) | Standard Deviation 0.7344 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8 | Change at Day 5 (n =13, 6, 6, 6, 5, 8, 8) | -0.170 cells per millimeter cube (cells/mm^3) | Standard Deviation 0.6963 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8 | Change at Day 2 (n =13, 7, 6, 6, 6, 8, 8) | -0.315 cells per millimeter cube (cells/mm^3) | Standard Deviation 0.8594 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8 | Baseline (n =13, 7, 6, 6, 6, 8, 8) | 2.973 cells per millimeter cube (cells/mm^3) | Standard Deviation 1.2374 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8 | Change at Day 5 (n =13, 6, 6, 6, 5, 8, 8) | 0.296 cells per millimeter cube (cells/mm^3) | Standard Deviation 0.3849 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8 | Change at Day 8 (n =12, 5, 6, 6, 5, 8, 8) | -0.110 cells per millimeter cube (cells/mm^3) | Standard Deviation 0.791 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8 | Change at Day 5 (n =13, 6, 6, 6, 5, 8, 8) | 0.654 cells per millimeter cube (cells/mm^3) | Standard Deviation 0.693 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8 | Baseline (n =13, 7, 6, 6, 6, 8, 8) | 2.858 cells per millimeter cube (cells/mm^3) | Standard Deviation 0.6901 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8 | Change at Day 2 (n =13, 7, 6, 6, 6, 8, 8) | -0.760 cells per millimeter cube (cells/mm^3) | Standard Deviation 0.5266 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8 | Change at Day 8 (n =12, 5, 6, 6, 5, 8, 8) | 1.188 cells per millimeter cube (cells/mm^3) | Standard Deviation 1.8134 |
Secondary
Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8
Time frame: Baseline, Day 2, 5, 8
Population: PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. Here, 'n' signifies those participants who were evaluable at specified time points for each arm, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8 | Change at Day 8 (n =12, 5, 6, 6, 5, 8, 8) | 0.03 cells/mm^3 | Standard Deviation 0.234 |
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8 | Change at Day 2 (n =13, 7, 6, 6, 6, 8, 8) | 0.02 cells/mm^3 | Standard Deviation 0.152 |
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8 | Baseline (n =13, 7, 6, 6, 6, 8, 8) | 1.23 cells/mm^3 | Standard Deviation 0.47 |
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8 | Change at Day 5 (n =13, 6, 6, 6, 5, 8, 8) | 0.04 cells/mm^3 | Standard Deviation 0.194 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8 | Baseline (n =13, 7, 6, 6, 6, 8, 8) | 1.19 cells/mm^3 | Standard Deviation 0.38 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8 | Change at Day 8 (n =12, 5, 6, 6, 5, 8, 8) | 0.04 cells/mm^3 | Standard Deviation 0.114 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8 | Change at Day 5 (n =13, 6, 6, 6, 5, 8, 8) | 0.07 cells/mm^3 | Standard Deviation 0.175 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8 | Change at Day 2 (n =13, 7, 6, 6, 6, 8, 8) | -0.09 cells/mm^3 | Standard Deviation 0.135 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8 | Change at Day 8 (n =12, 5, 6, 6, 5, 8, 8) | 0.03 cells/mm^3 | Standard Deviation 0.242 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8 | Baseline (n =13, 7, 6, 6, 6, 8, 8) | 0.98 cells/mm^3 | Standard Deviation 0.279 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8 | Change at Day 2 (n =13, 7, 6, 6, 6, 8, 8) | -0.02 cells/mm^3 | Standard Deviation 0.16 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8 | Change at Day 5 (n =13, 6, 6, 6, 5, 8, 8) | -0.05 cells/mm^3 | Standard Deviation 0.138 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8 | Change at Day 8 (n =12, 5, 6, 6, 5, 8, 8) | -0.15 cells/mm^3 | Standard Deviation 0.226 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8 | Baseline (n =13, 7, 6, 6, 6, 8, 8) | 1.25 cells/mm^3 | Standard Deviation 0.243 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8 | Change at Day 2 (n =13, 7, 6, 6, 6, 8, 8) | -0.15 cells/mm^3 | Standard Deviation 0.138 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8 | Change at Day 5 (n =13, 6, 6, 6, 5, 8, 8) | -0.27 cells/mm^3 | Standard Deviation 0.103 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8 | Change at Day 8 (n =12, 5, 6, 6, 5, 8, 8) | 0.34 cells/mm^3 | Standard Deviation 0.532 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8 | Baseline (n =13, 7, 6, 6, 6, 8, 8) | 1.25 cells/mm^3 | Standard Deviation 0.327 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8 | Change at Day 5 (n =13, 6, 6, 6, 5, 8, 8) | 0.02 cells/mm^3 | Standard Deviation 0.409 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8 | Change at Day 2 (n =13, 7, 6, 6, 6, 8, 8) | 0.02 cells/mm^3 | Standard Deviation 0.256 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8 | Change at Day 2 (n =13, 7, 6, 6, 6, 8, 8) | -0.14 cells/mm^3 | Standard Deviation 0.177 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8 | Baseline (n =13, 7, 6, 6, 6, 8, 8) | 1.44 cells/mm^3 | Standard Deviation 0.825 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8 | Change at Day 5 (n =13, 6, 6, 6, 5, 8, 8) | -0.23 cells/mm^3 | Standard Deviation 0.459 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8 | Change at Day 8 (n =12, 5, 6, 6, 5, 8, 8) | -0.26 cells/mm^3 | Standard Deviation 0.478 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8 | Change at Day 8 (n =12, 5, 6, 6, 5, 8, 8) | -0.14 cells/mm^3 | Standard Deviation 0.346 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8 | Baseline (n =13, 7, 6, 6, 6, 8, 8) | 1.20 cells/mm^3 | Standard Deviation 0.524 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8 | Change at Day 2 (n =13, 7, 6, 6, 6, 8, 8) | -0.16 cells/mm^3 | Standard Deviation 0.177 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8 | Change at Day 5 (n =13, 6, 6, 6, 5, 8, 8) | -0.15 cells/mm^3 | Standard Deviation 0.193 |
Secondary
Single Ascending Dose (SAD) Cohort: Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) of PF-06700841
Area under the plasma concentration time-curve from time zero to the time of last measured concentration (AUClast). AUClast(dn) was calculated by dividing AUClast by the exact dose of of PF-06700841 (in mg) administered to a participant.
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1
Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort arm.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) of PF-06700841 | 17.71 [ng*hr/mL]/mg | Geometric Coefficient of Variation 114 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) of PF-06700841 | 26.38 [ng*hr/mL]/mg | Geometric Coefficient of Variation 239 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) of PF-06700841 | 34.04 [ng*hr/mL]/mg | Geometric Coefficient of Variation 30 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) of PF-06700841 | 47.64 [ng*hr/mL]/mg | Geometric Coefficient of Variation 65 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) of PF-06700841 | 50.41 [ng*hr/mL]/mg | Geometric Coefficient of Variation 59 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) of PF-06700841 | 92.09 [ng*hr/mL]/mg | Geometric Coefficient of Variation 46 |
Secondary
Single Ascending Dose (SAD) Cohort: Dose Normalized Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf[dn]) of PF-06700841
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). AUCinf(dn) was calculated by dividing AUCinf by the exact dose of PF-06700841 (in mg) administered to a participant.
Time frame: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1
Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort arm.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Dose Normalized Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf[dn]) of PF-06700841 | NA [nanogram*hour/milliliter]/milligram | — |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Dose Normalized Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf[dn]) of PF-06700841 | 48.65 [nanogram*hour/milliliter]/milligram | Geometric Coefficient of Variation 61 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Dose Normalized Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf[dn]) of PF-06700841 | 35.38 [nanogram*hour/milliliter]/milligram | Geometric Coefficient of Variation 31 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Dose Normalized Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf[dn]) of PF-06700841 | 47.97 [nanogram*hour/milliliter]/milligram | Geometric Coefficient of Variation 65 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Dose Normalized Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf[dn]) of PF-06700841 | 47.97 [nanogram*hour/milliliter]/milligram | Geometric Coefficient of Variation 62 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Dose Normalized Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf[dn]) of PF-06700841 | 92.13 [nanogram*hour/milliliter]/milligram | Geometric Coefficient of Variation 46 |
Secondary
Single Ascending Dose (SAD) Cohort: High Sensitivity C-reactive Protein (hsCRP) Concentration in Serum at Baseline
Serum samples for hsCRP were analyzed using a validated analytical assay. Reference range for measurement of CRP was 0.015 to 2.0 mg/dL. LLOQ for hsCRP was 0.03 mg/dL and limit of detection was 0.015 mg/dL.
Time frame: Baseline
Population: PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: High Sensitivity C-reactive Protein (hsCRP) Concentration in Serum at Baseline | 0.1220 milligram per deciliter (mg/dL) | Standard Deviation 0.11909 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: High Sensitivity C-reactive Protein (hsCRP) Concentration in Serum at Baseline | 0.1066 milligram per deciliter (mg/dL) | Standard Deviation 0.09662 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: High Sensitivity C-reactive Protein (hsCRP) Concentration in Serum at Baseline | 0.6420 milligram per deciliter (mg/dL) | Standard Deviation 1.41413 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: High Sensitivity C-reactive Protein (hsCRP) Concentration in Serum at Baseline | 0.0757 milligram per deciliter (mg/dL) | Standard Deviation 0.04523 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: High Sensitivity C-reactive Protein (hsCRP) Concentration in Serum at Baseline | 0.2290 milligram per deciliter (mg/dL) | Standard Deviation 0.11714 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: High Sensitivity C-reactive Protein (hsCRP) Concentration in Serum at Baseline | 0.1158 milligram per deciliter (mg/dL) | Standard Deviation 0.20871 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: High Sensitivity C-reactive Protein (hsCRP) Concentration in Serum at Baseline | 0.1710 milligram per deciliter (mg/dL) | Standard Deviation 0.10387 |
Secondary
Single Ascending Dose (SAD) Cohort: Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Baseline
Serum samples for IP-10 were analyzed using a validated analytical assay. Lower limit of quantification (LLOQ) for IP-10 was 10 pg/mL.
Time frame: Baseline
Population: Pharmacodynamic (PD) analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo: SAD Cohort | Single Ascending Dose (SAD) Cohort: Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Baseline | 119.17 picogram per milliliter (pg/mL) | Standard Deviation 40.09 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD) Cohort: Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Baseline | 188.76 picogram per milliliter (pg/mL) | Standard Deviation 238.38 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Baseline | 219.62 picogram per milliliter (pg/mL) | Standard Deviation 275.44 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Baseline | 78.28 picogram per milliliter (pg/mL) | Standard Deviation 29.481 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Baseline | 141.38 picogram per milliliter (pg/mL) | Standard Deviation 100.403 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Baseline | 115.00 picogram per milliliter (pg/mL) | Standard Deviation 38.458 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD) Cohort: Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Baseline | 114.33 picogram per milliliter (pg/mL) | Standard Deviation 26.164 |
Secondary
Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Clearance (CL/F) of PF-06700841
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Clearance obtained after oral dose is influenced by the fraction of the dose absorbed. CL/F =Dose of PF-06700841/AUCinf.
Time frame: SAD: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post-dose on Day 1; MAD: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose on Day 28
Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo: SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Clearance (CL/F) of PF-06700841 | NA Liter per hour (L/hr) | — |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Clearance (CL/F) of PF-06700841 | 20.57 Liter per hour (L/hr) | Geometric Coefficient of Variation 61 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Clearance (CL/F) of PF-06700841 | 28.26 Liter per hour (L/hr) | Geometric Coefficient of Variation 31 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Clearance (CL/F) of PF-06700841 | 20.82 Liter per hour (L/hr) | Geometric Coefficient of Variation 65 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Clearance (CL/F) of PF-06700841 | 20.85 Liter per hour (L/hr) | Geometric Coefficient of Variation 61 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Clearance (CL/F) of PF-06700841 | 10.86 Liter per hour (L/hr) | Geometric Coefficient of Variation 46 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Clearance (CL/F) of PF-06700841 | 23.65 Liter per hour (L/hr) | Geometric Coefficient of Variation 41 |
| Placebo: Once Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Clearance (CL/F) of PF-06700841 | 15.95 Liter per hour (L/hr) | Geometric Coefficient of Variation 51 |
| Placebo: Twice Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Clearance (CL/F) of PF-06700841 | 16.43 Liter per hour (L/hr) | Geometric Coefficient of Variation 38 |
| PF-06700841: 10 mg Once Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Clearance (CL/F) of PF-06700841 | 14.03 Liter per hour (L/hr) | Geometric Coefficient of Variation 35 |
| PF-06700841: 30 mg Once Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Clearance (CL/F) of PF-06700841 | 10.83 Liter per hour (L/hr) | Geometric Coefficient of Variation 16 |
| PF-06700841: 100 mg Once Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Clearance (CL/F) of PF-06700841 | 30.30 Liter per hour (L/hr) | Geometric Coefficient of Variation 103 |
| PF-06700841: 50 mg Twice Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Clearance (CL/F) of PF-06700841 | 13.04 Liter per hour (L/hr) | Geometric Coefficient of Variation 43 |
Secondary
Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Volume of Distribution (Vz/F) of PF-06700841
Volume of distribution 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: SAD: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post-dose on Day 1; MAD: pre-dose 0.5, 1, 2, 4, 6, 8, 12, 24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose on Day 28
Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo: SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Volume of Distribution (Vz/F) of PF-06700841 | NA liter | — |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Volume of Distribution (Vz/F) of PF-06700841 | 126.4 liter | Standard Deviation 26 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Volume of Distribution (Vz/F) of PF-06700841 | 151.0 liter | Standard Deviation 18 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Volume of Distribution (Vz/F) of PF-06700841 | 115.7 liter | Standard Deviation 16 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Volume of Distribution (Vz/F) of PF-06700841 | 210.5 liter | Standard Deviation 45 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Volume of Distribution (Vz/F) of PF-06700841 | 102.4 liter | Standard Deviation 27 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Volume of Distribution (Vz/F) of PF-06700841 | 177.6 liter | Standard Deviation 30 |
| Placebo: Once Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Volume of Distribution (Vz/F) of PF-06700841 | 106.2 liter | Standard Deviation 12 |
| Placebo: Twice Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Volume of Distribution (Vz/F) of PF-06700841 | 249.4 liter | Standard Deviation 45 |
| PF-06700841: 10 mg Once Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Volume of Distribution (Vz/F) of PF-06700841 | 180.9 liter | Standard Deviation 30 |
| PF-06700841: 30 mg Once Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Volume of Distribution (Vz/F) of PF-06700841 | 112.4 liter | Standard Deviation 18 |
| PF-06700841: 100 mg Once Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Volume of Distribution (Vz/F) of PF-06700841 | 245.4 liter | Standard Deviation 206 |
| PF-06700841: 50 mg Twice Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Volume of Distribution (Vz/F) of PF-06700841 | 109.6 liter | Standard Deviation 18 |
Secondary
Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06700841
Dose normalized (dn) Cmax was calculated by dividing Cmax by the exact dose of PF 06700841 (in mg) administered to a participant.
Time frame: SAD: pre-dose, 0.5,1,2,4,6,8,12,16,24,36,48,72,96 hour post dose on Day 1; MAD: pre-dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5,1,2,4,6,8,12,16,24 hours post dose on Day 28
Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo: SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06700841 | 5.138 [nanogram/milliliter]/milligram | Geometric Coefficient of Variation 52 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06700841 | 6.061 [nanogram/milliliter]/milligram | Geometric Coefficient of Variation 92 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06700841 | 7.930 [nanogram/milliliter]/milligram | Geometric Coefficient of Variation 35 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06700841 | 9.033 [nanogram/milliliter]/milligram | Geometric Coefficient of Variation 21 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06700841 | 7.484 [nanogram/milliliter]/milligram | Geometric Coefficient of Variation 35 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06700841 | 12.31 [nanogram/milliliter]/milligram | Geometric Coefficient of Variation 37 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06700841 | 6.342 [nanogram/milliliter]/milligram | Geometric Coefficient of Variation 11 |
| Placebo: Once Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06700841 | 9.563 [nanogram/milliliter]/milligram | Geometric Coefficient of Variation 17 |
| Placebo: Twice Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06700841 | 7.341 [nanogram/milliliter]/milligram | Geometric Coefficient of Variation 29 |
| PF-06700841: 10 mg Once Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06700841 | 10.43 [nanogram/milliliter]/milligram | Geometric Coefficient of Variation 30 |
| PF-06700841: 30 mg Once Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06700841 | 11.97 [nanogram/milliliter]/milligram | Geometric Coefficient of Variation 28 |
| PF-06700841: 100 mg Once Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06700841 | 6.827 [nanogram/milliliter]/milligram | Geometric Coefficient of Variation 43 |
| PF-06700841: 50 mg Twice Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of PF-06700841 | 9.242 [nanogram/milliliter]/milligram | Geometric Coefficient of Variation 13 |
Secondary
Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841
Time frame: SAD: pre-dose, 0.5,1,2,4,6,8,12,16,24,36,48,72,96 hour post dose on Day 1; MAD: pre-dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5,1,2,4,6,8,12,16,24 hours post dose on Day 28
Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo: SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841 | 5.138 ng/mL | Geometric Coefficient of Variation 52 |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841 | 18.21 ng/mL | Geometric Coefficient of Variation 92 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841 | 79.30 ng/mL | Geometric Coefficient of Variation 35 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841 | 271.3 ng/mL | Geometric Coefficient of Variation 21 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841 | 748.4 ng/mL | Geometric Coefficient of Variation 35 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841 | 2460 ng/mL | Geometric Coefficient of Variation 37 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841 | 63.42 ng/mL | Geometric Coefficient of Variation 11 |
| Placebo: Once Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841 | 286.6 ng/mL | Geometric Coefficient of Variation 17 |
| Placebo: Twice Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841 | 734.1 ng/mL | Geometric Coefficient of Variation 29 |
| PF-06700841: 10 mg Once Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841 | 522.0 ng/mL | Geometric Coefficient of Variation 31 |
| PF-06700841: 30 mg Once Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841 | 2091 ng/mL | Geometric Coefficient of Variation 28 |
| PF-06700841: 100 mg Once Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841 | 204.7 ng/mL | Geometric Coefficient of Variation 43 |
| PF-06700841: 50 mg Twice Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841 | 924.2 ng/mL | Geometric Coefficient of Variation 13 |
Secondary
Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Mean Residence Time (MRT) of PF-06700841
MRT= AUMCinf/AUCinf, where AUMCinf is the area under the first moment curve from time 0 extrapolated to infinite time, calculated using the linear/log trapezoidal method.
Time frame: SAD: pre--dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post-dose on Day 1; MAD: pre--dose 0.5, 1, 2, 4, 6, 8, 12, 24 hour post--dose on Day 10; MAD Psoriasis: pre--dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post-dose on Day 28
Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo: SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Mean Residence Time (MRT) of PF-06700841 | NA hour | — |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Mean Residence Time (MRT) of PF-06700841 | 6.414 hour | Geometric Coefficient of Variation 46 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Mean Residence Time (MRT) of PF-06700841 | 5.169 hour | Geometric Coefficient of Variation 34 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Mean Residence Time (MRT) of PF-06700841 | 5.206 hour | Geometric Coefficient of Variation 44 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Mean Residence Time (MRT) of PF-06700841 | 7.277 hour | Geometric Coefficient of Variation 37 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Mean Residence Time (MRT) of PF-06700841 | 8.758 hour | Geometric Coefficient of Variation 29 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Mean Residence Time (MRT) of PF-06700841 | 7.191 hour | Geometric Coefficient of Variation 45 |
| Placebo: Once Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Mean Residence Time (MRT) of PF-06700841 | 6.830 hour | Geometric Coefficient of Variation 38 |
| Placebo: Twice Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Mean Residence Time (MRT) of PF-06700841 | 10.35 hour | Geometric Coefficient of Variation 25 |
| PF-06700841: 10 mg Once Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Mean Residence Time (MRT) of PF-06700841 | 9.592 hour | Geometric Coefficient of Variation 22 |
| PF-06700841: 30 mg Once Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Mean Residence Time (MRT) of PF-06700841 | 9.025 hour | Geometric Coefficient of Variation 26 |
| PF-06700841: 100 mg Once Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Mean Residence Time (MRT) of PF-06700841 | 6.072 hour | Geometric Coefficient of Variation 92 |
| PF-06700841: 50 mg Twice Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Mean Residence Time (MRT) of PF-06700841 | 8.534 hour | Geometric Coefficient of Variation 36 |
Secondary
Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Plasma Decay Half-Life (t1/2) of PF-06700841
Plasma decay half-life is the time measured for the plasma concentration of PF-06700841 to decrease by one half.
Time frame: SAD: pre--dose, 0.5,1,2,4,6,8,12,16,24,36,48,72,96 hour post-dose on Day 1; MAD: pre--dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10; MAD Psoriasis: pre--dose, 0.5,1,2,4,6,8,12,16,24 hours post-dose on Day 28
Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo: SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Plasma Decay Half-Life (t1/2) of PF-06700841 | NA hour | — |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Plasma Decay Half-Life (t1/2) of PF-06700841 | 4.554 hour | Standard Deviation 1.8066 |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Plasma Decay Half-Life (t1/2) of PF-06700841 | 3.848 hour | Standard Deviation 1.1587 |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Plasma Decay Half-Life (t1/2) of PF-06700841 | 4.363 hour | Standard Deviation 2.4126 |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Plasma Decay Half-Life (t1/2) of PF-06700841 | 7.519 hour | Standard Deviation 2.8236 |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Plasma Decay Half-Life (t1/2) of PF-06700841 | 6.813 hour | Standard Deviation 1.9875 |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Plasma Decay Half-Life (t1/2) of PF-06700841 | 5.928 hour | Standard Deviation 3.3336 |
| Placebo: Once Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Plasma Decay Half-Life (t1/2) of PF-06700841 | 4.860 hour | Standard Deviation 1.9304 |
| Placebo: Twice Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Plasma Decay Half-Life (t1/2) of PF-06700841 | 10.67 hour | Standard Deviation 1.844 |
| PF-06700841: 10 mg Once Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Plasma Decay Half-Life (t1/2) of PF-06700841 | 9.133 hour | Standard Deviation 2.2579 |
| PF-06700841: 30 mg Once Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Plasma Decay Half-Life (t1/2) of PF-06700841 | 7.458 hour | Standard Deviation 2.1595 |
| PF-06700841: 100 mg Once Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Plasma Decay Half-Life (t1/2) of PF-06700841 | 16.01 hour | Standard Deviation 31.584 |
| PF-06700841: 50 mg Twice Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Plasma Decay Half-Life (t1/2) of PF-06700841 | 6.032 hour | Standard Deviation 1.7121 |
| PF-06700841: 175 mg Once Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Plasma Decay Half-Life (t1/2) of PF-06700841 | 6.155 hour | Standard Deviation 1.4408 |
| Placebo: MAD Psoriasis Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Plasma Decay Half-Life (t1/2) of PF-06700841 | 6.168 hour | Standard Deviation 1.2965 |
| PF-06700841: 30 mg MAD Psoriasis Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Plasma Decay Half-Life (t1/2) of PF-06700841 | 5.848 hour | Standard Deviation 1.4383 |
Secondary
Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06700841
Time frame: SAD: pre-dose, 0.5,1,2,4,6,8,12,16,24,36,48,72,96 hour post dose on Day 1; MAD: pre-dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10; MAD Psoriasis: pre-dose, 0.5,1,2,4,6,8,12,16,24 hours post dose on Day 28
Population: PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. Here, 'N' signifies those participants who were evaluable for this outcome measure. Data for this outcome was not planned to be analyzed for Placebo: SAD Cohort, MAD Cohort, MAD Psoriasis Cohort arm
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo: SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06700841 | 1.00 hour |
| PF--06700841: 1 Milligram (mg) SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06700841 | 1.00 hour |
| PF--06700841: 3 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06700841 | 0.500 hour |
| PF-06700841: 10 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06700841 | 1.00 hour |
| PF-06700841: 30 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06700841 | 1.00 hour |
| PF-06700841: 100 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06700841 | 1.00 hour |
| PF-06700841: 200 mg SAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06700841 | 1.00 hour |
| Placebo: Once Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06700841 | 1.00 hour |
| Placebo: Twice Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06700841 | 1.50 hour |
| PF-06700841: 10 mg Once Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06700841 | 1.00 hour |
| PF-06700841: 30 mg Once Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06700841 | 0.984 hour |
| PF-06700841: 100 mg Once Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06700841 | 1.00 hour |
| PF-06700841: 50 mg Twice Daily MAD Cohort | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06700841 | 2.00 hour |