| Primary | Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 | | Full analysis set (FAS) included all participants who were randomized to treatment and received at least 1 dose of study medication. | Posted | | Mean | Standard Deviation | millimeter of mercury (mmHg) | | Baseline, 24 hours post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo: SAD Cohort | Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-06700841: 10 mg SAD Cohort | Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days. | | OG004 | PF-06700841: 30 mg SAD Cohort | Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days. | | OG005 | PF-06700841: 100 mg SAD Cohort | Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days. | | OG006 | PF-06700841: 200 mg SAD Cohort | Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days. |
| | | Title | Denominators | Categories |
|---|
| Supine Systolic Blood Pressure (SBP): Baseline | | | Title | Measurements |
|---|
| - OG000114.2± 11.97
- OG001110.6± 6.70
- OG002108.7± 7.76
- OG003
|
|
| |
| Primary | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10 | | 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. | Posted | | Mean | Standard Deviation | mmHg | | Baseline, 16 hours post-dose on Day 10 | | | | ID | Title | Description |
|---|
| OG000 | Placebo: Once Daily MAD Cohort | Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days. | | OG001 | Placebo: Twice Daily MAD Cohort | Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days. | | OG002 | PF-06700841: 10 mg Once Daily MAD Cohort | Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days. | | OG003 | PF-06700841: 30 mg Once Daily MAD Cohort | |
|
| Primary | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Blood Pressure at Day 28 | | 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. | Posted | | Mean | Standard Deviation | mmHg | | Baseline, 16 hours post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Primary | Single Ascending Dose (SAD) Cohort: Change From Baseline in Pulse Rate at Day 1 | | FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. | Posted | | Mean | Standard Deviation | beats per minute (bpm) | | Baseline, 24 hours post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo: SAD Cohort | Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-06700841: 10 mg SAD Cohort | Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days. |
|
| Primary | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Pulse Rate at Day 10 | | 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. | Posted | | Mean | Standard Deviation | bpm | | Baseline, 16 hours post-dose on Day 10 | | | | ID | Title | Description |
|---|
| OG000 | Placebo: Once Daily MAD Cohort | Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days. | | OG001 | Placebo: Twice Daily MAD Cohort | Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days. | | OG002 | PF-06700841: 10 mg Once Daily MAD Cohort | Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days. | | OG003 | PF-06700841: 30 mg Once Daily MAD Cohort | |
|
| Primary | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Pulse Rate at Day 28 | | 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. | Posted | | Mean | Standard Deviation | bpm | | Baseline, 16 hours post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Primary | Single Ascending Dose (SAD) Cohort: Change From Baseline in Oral Temperature at Day 1 | | FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. | Posted | | Mean | Standard Deviation | degree celsius | | Baseline, 24 hours post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo: SAD Cohort | Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-06700841: 10 mg SAD Cohort | Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days. |
|
| Primary | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Oral Temperature at Day 10 | | 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. | Posted | | Mean | Standard Deviation | degree celsius | | Baseline, 16 hours post-dose on Day 10 | | | | ID | Title | Description |
|---|
| OG000 | Placebo: Once Daily MAD Cohort | Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days. | | OG001 | Placebo: Twice Daily MAD Cohort | Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days. | | OG002 | PF-06700841: 10 mg Once Daily MAD Cohort | Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days. | | OG003 | PF-06700841: 30 mg Once Daily MAD Cohort |
|
| Primary | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Oral Temperature at Day 28 | | 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. | Posted | | Mean | Standard Deviation | degrees celsius | | Baseline, 16 hours post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| 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. | FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. | Posted | | Number | | participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Placebo: SAD Cohort | Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days. | | OG001 | 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. | | OG002 | 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. | | OG003 |
|
| 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 | | FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. | Posted | | Mean | Standard Deviation | millisecond (msec) | | Baseline, 24 hours post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo: SAD Cohort | Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-06700841: 10 mg SAD Cohort | Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days. |
|
| 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 | | 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. | Posted | | Mean | Standard Deviation | msec | | Baseline, 16 hours post-dose on Day 10 | | | | ID | Title | Description |
|---|
| OG000 | Placebo: Once Daily MAD Cohort | Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days. | | OG001 | Placebo: Twice Daily MAD Cohort | Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days. | | OG002 | PF-06700841: 10 mg Once Daily MAD Cohort | Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days. | | OG003 | PF-06700841: 30 mg Once Daily MAD Cohort |
|
| 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 | | 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. | Posted | | Mean | Standard Deviation | msec | | Baseline, 16 hours post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| Primary | Single Ascending Dose (SAD) Cohort: Change From Baseline in Heart Rate at Day 1 | | FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. | Posted | | Mean | Standard Deviation | bpm | | Baseline, 24 hours post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo: SAD Cohort | Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-06700841: 10 mg SAD Cohort | Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days. |
|
| Primary | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Heart Rate at Day 10 | | 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. | Posted | | Mean | Standard Deviation | bpm | | Baseline, 16 hours post-dose on Day 10 | | | | ID | Title | Description |
|---|
| OG000 | Placebo: Once Daily MAD Cohort | Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days. | | OG001 | Placebo: Twice Daily MAD Cohort | Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days. | | OG002 | PF-06700841: 10 mg Once Daily MAD Cohort | Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days. | | OG003 | PF-06700841: 30 mg Once Daily MAD Cohort | |
|
| Primary | Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Heart Rate at Day 28 | | 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. | Posted | | Mean | Standard Deviation | bpm | | Baseline, 16 hours post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| |
| 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. | FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. | Posted | | Number | | participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Placebo: SAD Cohort | Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days. | | OG001 | 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. |
|
| 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. | FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. | Posted | | Number | | adverse events | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Placebo: SAD Cohort | Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days. | | OG001 | 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. | | OG002 | 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. |
|
| 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) | FAS included all participants who were randomized to treatment and received at least 1 dose of study medication. | Posted | | Number | | participants | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Placebo: SAD Cohort | Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days. | | OG001 |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | milliliter per minute (mL/min) | | Baseline, 24 hours post-dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Placebo: SAD Cohort | Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days. | | OG001 | 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. | | OG002 | 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. | |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | mL/min | | Baseline, 16 hours post-dose on Day 10 | | | | ID | Title | Description |
|---|
| OG000 | Placebo: Once Daily MAD Cohort | Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days. | | OG001 | Placebo: Twice Daily MAD Cohort | Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days. | | OG002 | PF-06700841: 10 mg Once Daily MAD Cohort | Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days. |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | mL/min | | Baseline, 16 hours post-dose on Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| 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). | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | | Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | PF-06700841: 100 mg Tab Fasted (Food Effect Cohort) | All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study. | | OG001 | PF-06700841: 100 mg Solution Fasted (Food Effect Cohort) | All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study. | | OG002 | PF-06700841: 100 mg Tablet Fed (Food Effect Cohort) | All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study. |
|
| 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). | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | PF-06700841: 100 mg Tab Fasted (Food Effect Cohort) | All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study. | | OG001 | PF-06700841: 100 mg Solution Fasted (Food Effect Cohort) | All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study. | | OG002 | PF-06700841: 100 mg Tablet Fed (Food Effect Cohort) | All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study. |
|
| Primary | Food Effect Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841 | | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | PF-06700841: 100 mg Tab Fasted (Food Effect Cohort) | All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study. | | OG001 | PF-06700841: 100 mg Solution Fasted (Food Effect Cohort) | All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study. | | OG002 | PF-06700841: 100 mg Tablet Fed (Food Effect Cohort) | All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study. |
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| Secondary | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841 | | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 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 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | PF-06700841: 10 mg SAD Cohort | Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days. |
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| Secondary | Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06700841 | | 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 | Posted | | Median | Full Range | hour | | 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 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | PF-06700841: 10 mg SAD Cohort | Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days. |
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| Secondary | Food Effect Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF--06700841 | | PK parameter analysis set included all randomized and treated participants who had at least 1 of the PK parameters of interest. | Posted | | Median | Full Range | hour | | Pre--dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | PF-06700841: 100 mg Tab Fasted (Food Effect Cohort) | All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study. | | OG001 | PF-06700841: 100 mg Solution Fasted (Food Effect Cohort) | All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study. | | OG002 | PF-06700841: 100 mg Tablet Fed (Food Effect Cohort) | All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study. |
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| 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). | 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 | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | PF-06700841: 10 mg SAD Cohort | Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days. |
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| 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. | 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 | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | 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 | | | | ID | Title | Description |
|---|
| OG000 | PF-06700841: 10 mg Once Daily MAD Cohort | Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days. | | OG001 | PF-06700841: 30 mg Once Daily MAD Cohort | Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days. | | OG002 |
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| 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). | 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 | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | PF-06700841: 10 mg SAD Cohort | Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days. |
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| 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | [nanogram/milliliter]/milligram | | 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 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 |
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| 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | [nanogram*hour/milliliter]/milligram | | pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | PF-06700841: 10 mg SAD Cohort |
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| 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | [ng*hr/mL]/mg | | Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | PF-06700841: 10 mg SAD Cohort | |
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| 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | [ng*hr/mL]/mg | | pre-dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10 | | | | ID | Title | Description |
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| OG000 | PF-06700841: 10 mg Once Daily MAD Cohort | Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days. | | OG001 | PF-06700841: 30 mg Once Daily MAD Cohort | Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days. | | OG002 |
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| 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. | 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. | Posted | | Mean | Standard Deviation | hour | | 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 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | PF-06700841: 10 mg SAD Cohort | |
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| 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour | | 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 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 |
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| 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. | 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. | Posted | | Mean | Standard Deviation | liter | | 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 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter per hour (L/hr) | | 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 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | |
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| 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | 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 | | | | ID | Title | Description |
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| OG000 | PF-06700841: 10 mg Once Daily MAD Cohort | Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days. | | OG001 | PF-06700841: 30 mg Once Daily MAD Cohort | Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days. |
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| 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | milligram | | 0-24 hour on Day 10 | | | | ID | Title | Description |
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| OG000 | PF-06700841: 10 mg Once Daily MAD Cohort | Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days. | | OG001 | PF-06700841: 30 mg Once Daily MAD Cohort | Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days. | | OG002 | PF-06700841: 100 mg Once Daily MAD Cohort | |
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| 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | percentage of dose recovered | | 0-24 hours on Day 10 | | | | ID | Title | Description |
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| OG000 | PF-06700841: 10 mg Once Daily MAD Cohort | Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days. | | OG001 | PF-06700841: 30 mg Once Daily MAD Cohort | Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days. | | OG002 | PF-06700841: 100 mg Once Daily MAD Cohort |
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| 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter per hour | | 0-24 hours on Day 10 | | | | ID | Title | Description |
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| OG000 | PF-06700841: 10 mg Once Daily MAD Cohort | Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days. | | OG001 | PF-06700841: 30 mg Once Daily MAD Cohort | Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days. | | OG002 | PF-06700841: 100 mg Once Daily MAD Cohort |
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| 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. | Pharmacodynamic (PD) analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. | Posted | | Mean | Standard Deviation | picogram per milliliter (pg/mL) | | Baseline | | | | ID | Title | Description |
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| OG000 | Placebo: SAD Cohort | Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-06700841: 10 mg SAD Cohort |
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| 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. | 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. | Posted | | Mean | Standard Deviation | pg/mL | | Baseline, Day 2, 5, 10, 11, 28 | | | | ID | Title | Description |
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| OG000 | Placebo: Once Daily MAD Cohort | Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days. | | OG001 | Placebo: Twice Daily MAD Cohort | Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days. | | OG002 | PF-06700841: 10 mg Once Daily MAD Cohort | Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | pg/mL | | Baseline, Day 2, 5, 7, 14, 21, 28, 29, 35, 56 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| 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. | PD analysis set included all randomized and treated participants who had at least 1 of the PD parameters of interest. | Posted | | Mean | Standard Deviation | milligram per deciliter (mg/dL) | | Baseline | | | | ID | Title | Description |
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| OG000 | Placebo: SAD Cohort | Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days. | | OG001 | 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. | | OG002 | 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. | | OG003 |
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| 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. | 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. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, Day 2, 5, 10, 11, 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo: Once Daily MAD Cohort | Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days. | | OG001 | Placebo: Twice Daily MAD Cohort | Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days. | | OG002 | PF-06700841: 10 mg Once Daily MAD Cohort | Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, Day 2, 5 ,7,14, 21, 28, 29, 35, 56 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8 | | 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. | Posted | | Mean | Standard Deviation | cells per millimeter cube (cells/mm^3) | | Baseline, Day 2, 5, 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo: SAD Cohort | Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-06700841: 10 mg SAD Cohort | |
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| Secondary | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28 | | 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. | Posted | | Mean | Standard Deviation | cells/mm^3 | | Baseline, Day 4, 8, 10, 11, 14, 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo: Once Daily MAD Cohort | Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days. | | OG001 | Placebo: Twice Daily MAD Cohort | Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days. | | OG002 | PF-06700841: 10 mg Once Daily MAD Cohort | Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days. | | OG003 | PF-06700841: 30 mg Once Daily MAD Cohort |
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| 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 | | 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. | Posted | | Mean | Standard Deviation | cells/mm^3 | | Baseline, Day 4, 6 ,8,10, 13, 14, 21, 28, 35, 42, 56 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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| Secondary | Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8 | | 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. | Posted | | Mean | Standard Deviation | cells/mm^3 | | Baseline, Day 2, 5, 8 | | | | ID | Title | Description |
|---|
| OG000 | Placebo: SAD Cohort | Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days. | | OG001 | 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. | | OG002 | 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. | | OG003 | PF-06700841: 10 mg SAD Cohort | Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days. |
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| Secondary | Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28 | | 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. | Posted | | Mean | Standard Deviation | cells/mm^3 | | Baseline, Day 4, 8, 10, 11, 14, 28 | | | | ID | Title | Description |
|---|
| OG000 | Placebo: Once Daily MAD Cohort | Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days. | | OG001 | Placebo: Twice Daily MAD Cohort | Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days. | | OG002 | PF-06700841: 10 mg Once Daily MAD Cohort | Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days. | | OG003 | PF-06700841: 30 mg Once Daily MAD Cohort |
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| 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 | | 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. | Posted | | Mean | Standard Deviation | cells/mm^3 | | Baseline, Day 4, 6 ,8,10, 13, 14, 21, 28, 35, 42, 56 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
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