Plaque PsoriasisPhase 1NCT02310750

A Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06700841, With Bioavailability/Food Effect Investigation

A Phase 1 study testing PF-06700841 oral solution/suspension and PF-06700841 tablet in people with Plaque Psoriasis, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Plaque Psoriasis
What is being tested?: PF-06700841 oral solution/suspension and PF-06700841 tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 96 participants
Where: 1 siteUnited States
Study dates: Nov 2014to Feb 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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)
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

Who cannot join

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
Males of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product
Currently have non plaque forms of psoriasis, (eg, erythrodermic, guttate, or pustular psoriasis).
Have current drug induced psoriasis, eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, antimalarial drugs or lithium
Males of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product

Trial locations and contacts

1 site in 1 country.

United States1 site

Anaheim Clinical Trials, LLC
Anaheim, California, 92801

Other trials in United States

About this study

Official title: A Phase 1, Within Cohort, Randomized, Double Blind, Third-party Open, Placebo-controlled, Single- And Multiple Dose Escalation, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06700841 In Healthy Subjects And Subjects With Plaque Psoriasis And Bioavailability Of A Tablet Formulation Relative To Suspension Formulation And The Effect Of Food On A Tablet Formulation Of Pf-06700841

Conditions: Plaque Psoriasis
Being tested: PF-06700841 oral solution/suspension, Placebo, PF-06700841 tablet

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-06700841 oral solution/suspensionDrug
Oral solution or suspension of study drug PF-06700841 (once daily or twice daily during multiple dosing periods)
PlaceboOther
Matching placebo given during the single ascending and multiple dose periods
PF-06700841 tabletDrug
PF-06700841 tablet formulation administered during the bioavailability / food effect investigation

Study groups in NCT02310750
Study group	Role	What they receive
PF-06700841 Oral Solution/Suspension	Experimental	Not described Receives: Drug: PF-06700841 oral solution/suspension
PF-06700841 Tablet	Experimental	Not described Receives: Drug: PF-06700841 tablet
Placebo	Placebo comparator	Oral placebo comparator for the healthy subject single and multiple ascending dose periods, and the psoriasis multiple dose period. No placebo used for the bioavailability investigation. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1
Measured: Baseline, 24 hours post-dose on Day 1
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10
Measured: Baseline, 16 hours post-dose on Day 10
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Blood Pressure at Day 28
Measured: Baseline, 16 hours post-dose on Day 28
Single Ascending Dose (SAD) Cohort: Change From Baseline in Pulse Rate at Day 1
Measured: Baseline, 24 hours post-dose on Day 1
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Pulse Rate at Day 10
Measured: Baseline, 16 hours post-dose on Day 10
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Pulse Rate at Day 28
Measured: Baseline, 16 hours post-dose on Day 28
Single Ascending Dose (SAD) Cohort: Change From Baseline in Oral Temperature at Day 1
Measured: Baseline, 24 hours post-dose on Day 1
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Oral Temperature at Day 10
Measured: Baseline, 16 hours post-dose on Day 10
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Oral Temperature at Day 28
Measured: Baseline, 16 hours post-dose on Day 28
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.
Measured: 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
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
Measured: 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
Measured: 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
Measured: Baseline, 16 hours post-dose on Day 28
Single Ascending Dose (SAD) Cohort: Change From Baseline in Heart Rate at Day 1
Measured: Baseline, 24 hours post-dose on Day 1
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Heart Rate at Day 10
Measured: Baseline, 16 hours post-dose on Day 10
Multiple Ascending Dose (MAD) Psoriasis Cohort: Change From Baseline in Heart Rate at Day 28
Measured: 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
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.
Measured: 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
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.
Measured: 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
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)
Measured: 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
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.
Measured: Baseline, 24 hours post-dose on Day 1
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.
Measured: Baseline, 16 hours post-dose on Day 10
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.
Measured: Baseline, 16 hours post-dose on Day 28
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).
Measured: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1
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).
Measured: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1
Food Effect Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841
Measured: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1

Secondary outcomes (30)

Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Maximum Observed Plasma Concentration (Cmax) of PF-06700841
Measured: 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
Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-06700841
Measured: 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
Measured: 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
AUCinf = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).
Measured: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1
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.
Measured: 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
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).
Measured: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1
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.
Measured: 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
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.
Measured: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1
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.
Measured: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1
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.
Measured: pre-dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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: 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.
Measured: 0-24 hour on Day 10
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.
Measured: 0-24 hours on Day 10
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.
Measured: 0-24 hours on Day 10
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.
Measured: Baseline
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.
Measured: Baseline, Day 2, 5, 10, 11, 28
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.
Measured: Baseline, Day 2, 5, 7, 14, 21, 28, 29, 35, 56
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.
Measured: Baseline
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.
Measured: Baseline, Day 2, 5, 10, 11, 28
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.
Measured: Baseline, Day 2, 5 ,7,14, 21, 28, 29, 35, 56
Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8
Measured: Baseline, Day 2, 5, 8
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Neutrophil Counts at Day 4, 8, 10, 11, 14, 28
Measured: 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
Measured: 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
Measured: Baseline, Day 2, 5, 8
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 4, 8, 10, 11, 14 and 28
Measured: 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
Measured: Baseline, Day 4, 6 ,8,10, 13, 14, 21, 28, 35, 42, 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2014Feb 2016

First posted8 Dec 2014 (estimated)
Study startNov 2014
Primary completionJan 2016
Study completionFeb 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02310750
Sponsor's protocol ID: B7931001
Status last verified: Jan 2017
First submitted: 18 Nov 2014
Last updated: 8 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Wang C, Liu Z, He Y, Zhang Y, Chen S, Zhou Y, Yang W, Fan L. Identification of novel biomarkers related to pathogenesis and treatment of psoriasis based on integrated analysis of weighted gene co-expression network analysis and LASSO. PLoS One. 2025 Jun 25;20(6):e0317666. doi: 10.1371/journal.pone.0317666. eCollection 2025.
PubMed 40560938
Hughes JH, Qiu R, Banfield C, Dowty ME, Nicholas T. Population Pharmacokinetics of Oral Brepocitinib in Healthy Volunteers and Patients. Clin Pharmacol Drug Dev. 2022 Dec;11(12):1447-1456. doi: 10.1002/cpdd.1163. Epub 2022 Aug 31.
PubMed 36045513
Page KM, Suarez-Farinas M, Suprun M, Zhang W, Garcet S, Fuentes-Duculan J, Li X, Scaramozza M, Kieras E, Banfield C, Clark JD, Fensome A, Krueger JG, Peeva E. Molecular and Cellular Responses to the TYK2/JAK1 Inhibitor PF-06700841 Reveal Reduction of Skin Inflammation in Plaque Psoriasis. J Invest Dermatol. 2020 Aug;140(8):1546-1555.e4. doi: 10.1016/j.jid.2019.11.027. Epub 2020 Jan 21.
PubMed 31972249
Banfield C, Scaramozza M, Zhang W, Kieras E, Page KM, Fensome A, Vincent M, Dowty ME, Goteti K, Winkle PJ, Peeva E. The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a TYK2/JAK1 Inhibitor (PF-06700841) in Healthy Subjects and Patients With Plaque Psoriasis. J Clin Pharmacol. 2018 Apr;58(4):434-447. doi: 10.1002/jcph.1046. Epub 2017 Dec 21.
PubMed 29266308

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RecruitingPhase 4
A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)
Psoriasis, Overweight or Obesity
Active, not recruitingPhase 3
A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis

All Plaque Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Within Cohort, Randomized, Double Blind, Third-party Open, Placebo-controlled, Single- And Multiple Dose Escalation, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06700841 In Healthy Subjects And Subjects With Plaque Psoriasis And Bioavailability Of A Tablet Formulation Relative To Suspension Formulation And The Effect Of Food On A Tablet Formulation Of Pf-06700841
ClinicalTrials.gov ID: NCT02310750
Acronym / sponsor ID: B7931001
Conditions: Plaque Psoriasis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Nov 2014
Primary completion: Jan 2016 (actual)
Study completion: Feb 2016 (actual)
First posted: 8 Dec 2014 (estimated)
Results: Posted 8 Mar 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
PF-06700841 Oral Solution/Suspension	Experimental	Drug: PF-06700841 oral solution/suspension
PF-06700841 Tablet	Experimental	Drug: PF-06700841 tablet
Placebo	Placebo comparator	Other: PlaceboOral placebo comparator for the healthy subject single and multiple ascending dose periods, and the psoriasis multiple dose period. No placebo used for the bioavailability investigation.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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)
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

Key exclusion criteria (5 listed)

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
Males of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product
Currently have non plaque forms of psoriasis, (eg, erythrodermic, guttate, or pustular psoriasis).
Have current drug induced psoriasis, eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, antimalarial drugs or lithium
Males of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PF-06700841 oral solution/suspensionOral solution or suspension of study drug PF-06700841 (once daily or twice daily during multiple dosing periods)	Drug	PF-06700841 Oral Solution/Suspension
PlaceboMatching placebo given during the single ascending and multiple dose periods	Other	Placebo
PF-06700841 tabletPF-06700841 tablet formulation administered during the bioavailability / food effect investigation	Drug	PF-06700841 Tablet

Primary outcome

Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1
Time frame: Baseline, 24 hours post-dose on Day 1
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10
Time frame: Baseline, 16 hours post-dose on Day 10
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
Single Ascending Dose (SAD) Cohort: Change From Baseline in Pulse Rate at Day 1
Time frame: Baseline, 24 hours post-dose on Day 1
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Pulse Rate at Day 10
Time frame: Baseline, 16 hours post-dose on Day 10
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
Single Ascending Dose (SAD) Cohort: Change From Baseline in Oral Temperature at Day 1
Time frame: Baseline, 24 hours post-dose on Day 1
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Oral Temperature at Day 10
Time frame: Baseline, 16 hours post-dose on Day 10
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
Number of Participants With Change From Baseline in Physical Examinations
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
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
Time frame: 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
Time frame: 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
Time frame: Baseline, 16 hours post-dose on Day 28
Single Ascending Dose (SAD) Cohort: Change From Baseline in Heart Rate at Day 1
Time frame: Baseline, 24 hours post-dose on Day 1
Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Heart Rate at Day 10
Time frame: Baseline, 16 hours post-dose on Day 10
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
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs
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
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
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
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
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
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72 hours post dose on Day 1

30 secondary outcomes

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
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
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
Single Ascending Dose (SAD) Cohort: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of PF-06700841
Time frame: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1
Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-06700841
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
Single Ascending Dose (SAD) Cohort: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06700841
Time frame: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1
Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) 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
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
Time frame: pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1
Single Ascending Dose (SAD) Cohort: Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn]) of PF-06700841
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 hour post dose on Day 1
Multiple Ascending Dose (MAD) Cohort: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau[dn]) of PF-06700841
Time frame: pre-dose 0.5,1,2,4,6,8,12,24 hour post-dose on Day 10
Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Plasma Decay Half-Life (t1/2) 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
Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Mean Residence Time (MRT) 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
Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Volume of Distribution (Vz/F) 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
Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Apparent Clearance (CL/F) 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, 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
Multiple Ascending Dose (MAD) and MAD Psoriasis Cohort: Peak-Trough Fluctuation (PTF) of PF-06700841
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
Multiple Ascending Dose (MAD) Cohort: Amount of PF-06700841 Recovered Unchanged in the Urine Over the Time Interval Tau (Aetau)
Time frame: 0-24 hour on Day 10
Multiple Ascending Dose (MAD) Cohort: Percentage of Dose of PF-06700841 Recovered Unchanged in the Urine Over the Time Interval Tau (Aetau%)
Time frame: 0-24 hours on Day 10
Multiple Ascending Dose (MAD) Cohort: Renal Clearance
Time frame: 0-24 hours on Day 10
Single Ascending Dose (SAD) Cohort: Interferon Gamma-induced Protein 10 (IP-10) Concentration in Serum at Baseline
Time frame: Baseline
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
Time frame: Baseline, Day 2, 5, 10, 11, 28
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
Time frame: Baseline, Day 2, 5, 7, 14, 21, 28, 29, 35, 56
Single Ascending Dose (SAD) Cohort: High Sensitivity C-reactive Protein (hsCRP) Concentration in Serum at Baseline
Time frame: Baseline
Multiple Ascending Dose (MAD) Cohort: Change From Baseline In High Sensitivity C-reactive Protein (hsCRP) at Day 2, 5, 10, 11, 28
Time frame: Baseline, Day 2, 5, 10, 11, 28
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
Time frame: Baseline, Day 2, 5 ,7,14, 21, 28, 29, 35, 56
Single Ascending Dose (SAD) Cohort: Change From Baseline in Neutrophil Counts at Day 2, 5 and 8
Time frame: Baseline, Day 2, 5, 8
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
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
Single Ascending Dose (SAD) Cohort: Change From Baseline in Reticulocyte Counts at Day 2, 5, 8
Time frame: Baseline, Day 2, 5, 8
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
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

Results and safety

Results posted to the registry on 8 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PF--06700841: 1 Milligram (mg) SAD Cohort	7	6
PF--06700841: 3 mg SAD Cohort	6	6
PF--06700841: 10 mg SAD Cohort Then MAD Cohort	6	6
PF-06700841: 30 mg SAD Cohort Then MAD Cohort	6	5
PF--06700841: 100 mg SAD, 100 mg MAD, 50 mg MAD Cohort	8	8
PF--06700841: 200 mg SAD Cohort, 175 mg MAD Cohort	8	8
Placebo: SAD Cohort Then MAD Cohort	13	12
Placebo: MAD Psoriasis Cohort	0	0
PF-06700841: 30 mg MAD Psoriasis Cohort	0	0
PF-06700841: 100 mg MAD Psoriasis Cohort	0	0
PF-06700841: 100 mg Tablet Fasted, Tablet Fed, Solution Fasted	2	2
PF-06700841: 100 mg Solution Fasted, Tablet Fasted, Tablet Fed	2	2
PF-06700841: 100 mg Tablet Fed, Solution Fasted, Tablet Fasted	2	2
PF-06700841: 100 mg Tablet Fasted, Solution Fasted, Tablet Fed	2	2
PF-06700841: 100 mg Solution Fasted, Tablet Fed, Tablet Fasted	2	2
PF-06700841: 100 mg Tablet Fed, Tablet Fasted, Solution Fasted	2	2

Primary outcome: Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1

Time frame: Baseline, 24 hours post-dose on Day 1. Mean (Standard Deviation). Unit: millimeter of mercury (mmHg)

Measure	Placebo: SAD Cohort n = 13	PF--06700841: 1 Milligram (mg) SAD Cohort n = 7	PF--06700841: 3 mg SAD Cohort n = 6	PF-06700841: 10 mg SAD Cohort n = 6	PF-06700841: 30 mg SAD Cohort n = 6	PF-06700841: 100 mg SAD Cohort n = 8	PF-06700841: 200 mg SAD Cohort n = 8
Supine Systolic Blood Pressure (SBP): Baseline	114.2 (11.97)	110.6 (6.70)	108.7 (7.76)	102.8 (6.62)	117.8 (9.54)	112.4 (12.26)	115.3 (5.99)
Supine SBP: Change at Day 1	-2.6 (6.40)	-8.1 (9.32)	1.0 (8.17)	9.5 (5.96)	-1.5 (4.64)	2.1 (11.28)	-5.3 (7.91)
Supine Diastolic blood pressure (DBP): Baseline	64.0 (8.55)	67.0 (8.77)	66.2 (8.42)	58.7 (8.19)	70.3 (7.39)	66.9 (8.98)	70.5 (5.88)
Supine DBP: Change at Day 1	-1.1 (7.44)	-5.3 (9.05)	2.2 (9.56)	4.7 (715)	2.5 (8.83)	-0.1 (8.36)	-2.3 (6.14)

Population analysed: Full analysis set (FAS) included all participants who were randomized to treatment and received at least 1 dose of study medication.

Primary outcome: Multiple Ascending Dose (MAD) Cohort: Change From Baseline in Blood Pressure at Day 10

Time frame: Baseline, 16 hours post-dose on Day 10. Mean (Standard Deviation). Unit: mmHg

Measure	Placebo: Once Daily MAD Cohort n = 9	Placebo: Twice Daily MAD Cohort n = 2	PF-06700841: 10 mg Once Daily MAD Cohort n = 5	PF-06700841: 30 mg Once Daily MAD Cohort n = 4	PF-06700841: 100 mg Once Daily MAD Cohort n = 6	PF-06700841: 50 mg Twice Daily MAD Cohort n = 5	PF-06700841: 175 mg Once Daily MAD Cohort n = 6
Supine SBP: Baseline (n=9,2,5,4,6,5,6)	112.2 (9.78)	106.5 (3.54)	103.6 (7.64)	110.3 (5.19)	111.5 (13.35)	108.6 (18.45)	115.8 (8.66)
Supine SBP: Change at Day 10 (n=9,2,5,3,6,4,4)	4.0 (9.12)	12.5 (2.12)	-0.2 (7.69)	8.7 (10.69)	7.7 (12.97)	-3.5 (8.89)	-5.3 (4.86)
Supine DBP: Baseline (n=9,2,5,4,6,5,6)	60.3 (4.15)	61.5 (7.78)	56.2 (4.02)	65.5 (3.70)	68.8 (9.06)	59.2 (16.80)	66.2 (8.06)
Supine DBP: Change at Day 10 (n=9,2,5,3,6,4,4)	4.2 (7.26)	6.0 (4.24)	2.2 (6.76)	5.7 (1.53)	3.2 (9.62)	-4.3 (9.14)	2.0 (5.48)

Population analysed: 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.

Primary outcome: 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. Mean (Standard Deviation). Unit: mmHg

Measure	Placebo: MAD Psoriasis Cohort n = 9	PF-06700841: 30 mg MAD Psoriasis Cohort n = 14	PF-06700841: 100 mg MAD Psoriasis Cohort n = 7
Supine SBP: Baseline (n =9, 14, 7)	115.0 (13.21)	120.1 (10.91)	112.9 (8.11)
Supine SBP: Change at Day 28 (n =8, 7, 5)	-5.3 (11.87)	-8.9 (9.94)	1.0 (11.94)
Supine DBP: Baseline (n =9, 14, 7)	67.8 (7.93)	69.9 (7.94)	66.6 (7.55)
Supine DBP: Change at Day 28 (n =8, 7, 5)	-3.9 (5.51)	-7.0 (6.00)	-0.8 (16.96)

Primary outcome: Single Ascending Dose (SAD) Cohort: Change From Baseline in Pulse Rate at Day 1

Time frame: Baseline, 24 hours post-dose on Day 1. Mean (Standard Deviation). Unit: beats per minute (bpm)

Measure	Placebo: SAD Cohort n = 13	PF--06700841: 1 Milligram (mg) SAD Cohort n = 7	PF--06700841: 3 mg SAD Cohort n = 6	PF-06700841: 10 mg SAD Cohort n = 6	PF-06700841: 30 mg SAD Cohort n = 6	PF-06700841: 100 mg SAD Cohort n = 8	PF-06700841: 200 mg SAD Cohort n = 8
Baseline	57.5 (6.36)	68.6 (13.81)	67.2 (9.66)	56.0 (8.05)	67.3 (9.24)	55.8 (11.77)	57.8 (6.54)
Change at Day 1	1.0 (3.42)	6.1 (7.58)	2.5 (6.28)	3.0 (8.10)	0.7 (5.54)	-1.1 (3.94)	2.6 (6.39)

Population analysed: FAS included all participants who were randomized to treatment and received at least 1 dose of study medication.

30 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo: SAD Cohort	0 of 13 (0%)	2 of 13 (15.4%)	Not reported
Placebo: Once Daily MAD Cohort	0 of 9 (0%)	0 of 9 (0%)	Not reported
Placebo: Twice Daily MAD Cohort	0 of 2 (0%)	1 of 2 (50%)	Not reported
Placebo: MAD Psoriasis Cohort	0 of 9 (0%)	5 of 9 (55.6%)	Not reported
PF--06700841: 1 Milligram (mg) SAD Cohort	0 of 7 (0%)	1 of 7 (14.3%)	Not reported
PF--06700841: 3 mg SAD Cohort	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
PF-06700841: 10 mg SAD Cohort	0 of 6 (0%)	0 of 6 (0%)	Not reported
PF-06700841: 10 mg Once Daily MAD Cohort	0 of 5 (0%)	3 of 5 (60%)	Not reported
PF-06700841: 30 mg SAD Cohort	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
PF-06700841: 30 mg Once Daily MAD Cohort	0 of 4 (0%)	2 of 4 (50%)	Not reported
PF-06700841: 100 mg SAD Cohort	0 of 8 (0%)	3 of 8 (37.5%)	Not reported
PF-06700841: 100 mg Once Daily MAD Cohort	0 of 6 (0%)	3 of 6 (50%)	Not reported
PF-06700841: 50 mg Twice Daily MAD Cohort	0 of 5 (0%)	5 of 5 (100%)	Not reported
PF-06700841: 200 mg SAD Cohort	0 of 8 (0%)	2 of 8 (25%)	Not reported
PF-06700841: 175 mg Once Daily MAD Cohort	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
PF-06700841: 30 mg MAD Psoriasis Cohort	0 of 14 (0%)	11 of 14 (78.6%)	Not reported
PF-06700841: 100 mg MAD Psoriasis Cohort	0 of 7 (0%)	6 of 7 (85.7%)	Not reported
PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)	0 of 12 (0%)	1 of 12 (8.3%)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40560938Wang C, Liu Z, He Y, Zhang Y, Chen S, Zhou Y, Yang W, Fan L. Identification of novel biomarkers related to pathogenesis and treatment of psoriasis based on integrated analysis of weighted gene co-expression network analysis and LASSO. PLoS One. 2025 Jun 25;20(6):e0317666. doi: 10.1371/journal.pone.0317666. eCollection 2025.
Derived from this study: PubMed 36045513Hughes JH, Qiu R, Banfield C, Dowty ME, Nicholas T. Population Pharmacokinetics of Oral Brepocitinib in Healthy Volunteers and Patients. Clin Pharmacol Drug Dev. 2022 Dec;11(12):1447-1456. doi: 10.1002/cpdd.1163. Epub 2022 Aug 31.
Derived from this study: PubMed 31972249Page KM, Suarez-Farinas M, Suprun M, Zhang W, Garcet S, Fuentes-Duculan J, Li X, Scaramozza M, Kieras E, Banfield C, Clark JD, Fensome A, Krueger JG, Peeva E. Molecular and Cellular Responses to the TYK2/JAK1 Inhibitor PF-06700841 Reveal Reduction of Skin Inflammation in Plaque Psoriasis. J Invest Dermatol. 2020 Aug;140(8):1546-1555.e4. doi: 10.1016/j.jid.2019.11.027. Epub 2020 Jan 21.
Derived from this study: PubMed 29266308Banfield C, Scaramozza M, Zhang W, Kieras E, Page KM, Fensome A, Vincent M, Dowty ME, Goteti K, Winkle PJ, Peeva E. The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a TYK2/JAK1 Inhibitor (PF-06700841) in Healthy Subjects and Patients With Plaque Psoriasis. J Clin Pharmacol. 2018 Apr;58(4):434-447. doi: 10.1002/jcph.1046. Epub 2017 Dec 21.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-06700841 oral solution/suspension and PF-06700841 tablet in people with Plaque Psoriasis, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Single Ascending Dose (SAD) Cohort: Change From Baseline in Blood Pressure at Day 1 (time frame: Baseline, 24 hours post-dose on Day 1). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02310750, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2017.