Plaque PsoriasisPhase 1NCT03210961

A First in Human Study to Evaluate Safety, Tolerability, and Pharmacology of PF-06826647 in Healthy Subjects and Subjects With Plaque Psoriasis

A Phase 1 study testing PF-06826647 tablet and PF-06826647 oral suspension 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

This first in human study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-06826647 in healthy subjects and subjects with plaque psoriasis. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Plaque Psoriasis
What is being tested?: PF-06826647 tablet and PF-06826647 oral suspension
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 109 participants
Where: 1 siteUnited States
Study dates: 14 Jul 2017to 25 Jan 2019
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male subjects between ages of 18-55 years
Healthy female subjects of non-childbearing potential between the ages of 18-55 years
Body Mass Index (BMI) of 17.5 to 30.5kg/m2; and a total body weight >50kg (110lbs).
No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
(Optional) Japanese subjects who have four Japanese biologic grandparents born in Japan
Healthy male subjects between ages of 18-65 years

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Healthy female subjects of non-childbearing potential between the ages of 18-65 years
Have a diagnosis of plaque psoriasis for at least 6 months prior to first study dose
Have plaque-type psoriasis covering at least 15% of total body surface area (BSA) at Day-1(prior to randomization in the study
No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)

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)
Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential
Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product
Have a clinically significant infection currently or within 6 months of first dose of study drug
Psoriasis Participants:
Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis

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Have a clinically significant infection currently or within 6 months of first dose of study drug, or a history of chronic or recurrent infectious disease
Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential
Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product

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-06826647 IN HEALTHY SUBJECTS AND SUBJECTS WITH PLAQUE PSORIASIS

This first in human study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-06826647 in healthy subjects and subjects with plaque psoriasis.

Conditions: Plaque Psoriasis
Being tested: PF-06826647 tablet, PF-06826647 oral suspension, Placebo oral solution/suspension, Placebo tablet

What participants receive

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

PF-06826647 tabletDrug
PF-06826647 tablet for oral administration
PF-06826647 oral suspensionDrug
PF-06826647 suspension for oral administration (oral suspension to be administered to the 3mg starting dose cohort only)
Placebo oral solution/suspensionOther
placebo oral solution for the single ascending dose, first cohort only
Placebo tabletOther
Matching placebo tablet

Study groups in NCT03210961
Study group	Role	What they receive
PF-06826647 tablet	Experimental	Not described Receives: Drug: PF-06826647 tablet
Placebo tablet	Placebo comparator	Not described Receives: Other: Placebo tablet
PF-06826647 oral suspension	Experimental	Not described Receives: Drug: PF-06826647 oral suspension
Placebo oral solution/suspension	Placebo comparator	Not described Receives: Other: Placebo oral solution/suspension

What is being measured

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

Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period)
Maximum absolute values and changes from baseline for vital signs (for supine systolic/diastolic blood pressure [BP] and supine pulse rate [PR]) were summarized descriptively by treatment. Numbers of participants meeting the categorical criteria were provided.
Number of participants in PBO SAD cohorts = number of participants in [PBO SAD (3mg, 10mg)] cohorts + number of participants in [PBO SAD -> PBO QD MAD] cohorts.
Measured: Baseline up to Day 8
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period)
Maximum absolute values and changes from baseline for vital signs (for supine systolic/diastolic blood pressure and supine pulse rate) were summarized descriptively by treatment. Numbers of participants meeting the categorical criteria were provided.
Measured: Baseline up to Day 28
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
Maximum absolute values and changes from baseline for vital signs (for supine systolic/diastolic blood pressure and supine pulse rate) were summarized descriptively by treatment. Numbers of participants meeting the categorical criteria were provided.
Measured: Baseline up to Day 56
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period)
Physical examinations were conducted by a physician, trained physician assistant, or nurse practitioner as acceptable according to local regulation. A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The examination assessed the participants for any potential changes in general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. Findings were considered to be clinically significant based on investigator's decision.
Number of participants in PBO SAD cohorts = number of participants in [PBO SAD (3mg, 10mg)] cohorts + number of participants in [PBO SAD -> PBO QD MAD] cohorts.
Measured: Baseline up to Day 8
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period)
Physical examinations were conducted by a physician, trained physician assistant, or nurse practitioner as acceptable according to local regulation. A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The examination assessed the participants for any potential changes in general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. Findings were considered to be clinically significant based on investigator's decision.
Measured: Baseline up to Day 28
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
Physical examinations were conducted by a physician, trained physician assistant, or nurse practitioner as acceptable according to local regulation. A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The examination assessed the participants for any potential changes in general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. Findings were considered to be clinically significant based on investigator's decision.
Measured: Baseline up to Day 56
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period)
ECG endpoints and changes from baseline (QTcF, PR and QRS) were summarized descriptively by cohort and treatment using pre-defined categories. Numbers of participants meeting the categorical criteria were provided. All planned and unplanned post-dose time points were counted in these categorical summaries. Categorical summarization criteria for ECG were as follows: 1) QTcF maximum absolute value ≥450 and <480 millisecond (msec), ≥480 and <500 msec. ≥500 msec; 2) QTcF maximum increase ≥30 and <60 msec, ≥60 msec; 3) PR maximum absolute value ≥300 msec; 4) PR maximum increases from baseline ≥25% if baseline >200 msec, ≥50% if baseline ≤200 msec; 5) QRS maximum absolute value ≥140 msec; 6) QRS maximum increase from baseline ≥50%.
Number of participants in PBO SAD cohorts = number of participants in [PBO SAD (3mg, 10mg)] cohorts + number of participants in [PBO SAD -> PBO QD MAD] cohorts.
Measured: Baseline up to Day 8
Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period)
ECG endpoints and changes from baseline (QTcF, PR and QRS) were summarized descriptively by cohort and treatment using pre-defined categories. Numbers of participants meeting the categorical criteria were provided. All planned and unplanned post-dose time points were counted in these categorical summaries. Categorical summarization criteria for ECG were as follows: 1) QTcF maximum absolute value ≥450 and <480 millisecond (msec), ≥480 and <500 msec. ≥500 msec; 2) QTcF maximum increase ≥30 and <60 msec, ≥60 msec; 3) PR maximum absolute value ≥300 msec; 4) PR maximum increases from baseline ≥25% if baseline >200 msec, ≥50% if baseline ≤200 msec; 5) QRS maximum absolute value ≥140 msec; 6) QRS maximum increase from baseline ≥50%.
Measured: Baseline up to Day 28
Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
ECG endpoints and changes from baseline (QTcF, PR and QRS) were summarized descriptively by cohort and treatment using pre-defined categories. Numbers of participants meeting the categorical criteria were provided. All planned and unplanned post-dose time points were counted in these categorical summaries. Categorical summarization criteria for ECG were as follows: 1) QTcF maximum absolute value ≥450 and <480 millisecond (msec), ≥480 and <500 msec. ≥500 msec; 2) QTcF maximum increase ≥30 and <60 msec, ≥60 msec; 3) PR maximum absolute value ≥300 msec; 4) PR maximum increases from baseline ≥25% if baseline >200 msec, ≥50% if baseline ≤200 msec; 5) QRS maximum absolute value ≥140 msec; 6) QRS maximum increase from baseline ≥50%.
Measured: Baseline up to Day 56
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period)
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. All events occurring following start of the treatment or increasing in severity were counted as treatment emergent. Events that occurred in a non-treatment period (eg, washout or follow-up) were counted as treatment emergent and attributed to the previous treatment taken. For each event, the investigator pursued and obtained adequate information both to determine the outcome and to assess whether it meets the criteria for classification as an SAE.
PBO SAD cohorts = [PBO SAD (3mg, 10mg)] cohorts + [PBO SAD -> PBO QD MAD] cohorts.
Measured: Baseline up to Day 8
Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period)
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. All events occurring following start of the treatment or increasing in severity were counted as treatment emergent. Events that occurred in a non-treatment period (eg, washout or follow-up) were counted as treatment emergent and attributed to the previous treatment taken. For each event, the investigator pursued and obtained adequate information both to determine the outcome and to assess whether it meets the criteria for classification as an SAE.
Measured: Baseline up to Day 28
Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts)
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. All events occurring following start of the treatment or increasing in severity were counted as treatment emergent. Events that occurred in a non-treatment period (eg, washout or follow-up) were counted as treatment emergent and attributed to the previous treatment taken. For each event, the investigator pursued and obtained adequate information both to determine the outcome and to assess whether it meets the criteria for classification as an SAE.
Measured: Baseline up to Day 84
Number of Participants With Laboratory Abnormalities (SAD Period)
Laboratory data were listed and summarized by treatment in accordance with the sponsor reporting standards. Parameters for laboratory abnormalities evaluation included: erythrocyte mean corpuscular volume (Ery. MCV), erythrocyte mean corpuscular hemoglobin (Ery. MCH), reticulocytes/erythrocytes (%), limphocytes, eosinophils, bilirubin, aspartate aminotransferase (AST), urate, high-density lipoproteins (HDL) cholesterol, low-density lipoproteins (LDL) cholesterol, triglycerides, cholesterol, ketones, nitrite, leukocyte esterase, epithelial cells, urinalysis-bacteria.
Number of participants in PBO SAD cohorts = number of participants in [PBO SAD (3mg, 10mg)] cohorts + number of participants in [PBO SAD -> PBO QD MAD] cohorts.
Measured: Baseline up to Day 8
Number of Participants With Laboratory Abnormalities (MAD Period)
Laboratory data were listed and summarized by treatment in accordance with the sponsor reporting standards. Parameters and corresponding primary criteria for laboratory abnormalities evaluation included: Ery. MCV <0.9 × LLN, Ery. Mean corpuscular hemoglobin (Ery. MCH) <0.9 × LLN or >1.1 ULN, reticulocytes/erythrocytes (%) >1.5 × ULN, lymphocytes <0.8 × LLN or >1.2 × ULN, neutrophils <0.8 × LLN, eosinophils >1.2 × ULN, bilirubin >1.5 × ULN, urate >1.2 × ULN, HDL cholesterol <0.8 × LLN, LDL cholesterol >1.2 × ULN, triglycerides >1.3 × ULN, bicarbonate >1.1 × ULN, cholesterol >1.3 × ULN, urine glucose ≥1, urine hemoglobin ≥1, nitrite ≥1, leukocyte esterase ≥1, epithelial cells ≥6/LPF, urinalysis-casts >1/LPF, urinalysis-bacteria >20/HPF, urine 24 hours creatinine >1.1 × ULN.
Measured: Baseline up to Day 28
Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)
Laboratory data were listed and summarized by treatment in accordance with the sponsor reporting standards. Parameters and corresponding primary criteria for laboratory abnormalities evaluation included: reticulocytes/erythrocytes (%) >1.5 × ULN, lymphocytes <0.8 × LLN, neutrophils <0.8 × LLN or >1.2 × ULN, eosinophils >1.2 × ULN, bilirubin >1.5 × ULN, alanine aminotransferase (ALT) >3.0 × ULN, creatinine >1.3 × ULN, urate >1.2 × ULN, HDL cholesterol <0.8 × LLN, LDL cholesterol >1.2 × ULN, triglycerides >1.3 × ULN, potassium >1.1 × ULN, bicarbonate >1.1 × ULN, glucose <0.6 × LLN or >1.5 × ULN, Creatine Kinase (CK) >2.0 × ULN, cholesterol >1.3 × ULN, urine glucose ≥1, ketones ≥1, urine hemoglobin ≥1, urine bilirubin ≥1, leukocyte esterase ≥1, epithelial cells ≥6/LPF, urinalysis-bacteria/HPF.
Measured: Baseline up to Day 56
Change in 24 Hour Creatinine Clearance From Day -1 on Day 10 (MAD Period)
Change in 24-hour creatinine clearance at Day 10 from Day -1 (baseline) during the MAD was presented by treatment group.
Measured: Day -1 and Day 10

Secondary outcomes (47)

Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) (SAD Period)
AUCinf = Area under the plasma concentration versus time curve (AUC) from time 0 (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf).
Measured: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Secondary: Dose Normalized AUCinf (AUCinf[dn]) (SAD Period)
AUCinf = Area under the plasma concentration versus time curve (AUC) from time 0 (pre-dose) to extrapolated infinite time (0-inf). It is obtained from AUC (0-t) plus AUC (t-inf). AUCinf(dn) = AUCinf / dose. Dose normalized AUC values of PF-06826647 was plotted against dose and included individual participant values and the geometric means for each dose. These plots were used to help understand the relationship between the plasma PK parameters and dose.
Measured: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Area Under the Concentration-Time Profile From Time 0 to 24 Hours (AUC24) (SAD Period)
AUC24 was summarized by dosing regimen and period. It was determined by linear/log trapezoidal method.
Measured: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) (SAD Period)
AUClast was summarized by dosing regimen and period. It was determined by linear/log trapezoidal method.
Measured: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Dose Normalized AUClast (AUClast[dn]) (SAD Period)
AUClast(dn) = AUClast / dose. Dose normalized AUC values of PF-06826647 were plotted against dose and included individual participant values and the geometric means for each dose. These plots was used to help understand the relationship between the plasma PK parameters and dose.
Measured: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Maximum Plasma Concentration (Cmax) (SAD Period)
Cmax was summarized by dosing regimen and period. It was observed directly from data.
Measured: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Dose Normalized Cmax (Cmax[dn]) (SAD Period)
Cmax(dn) = Cmax / dose. To assess the relationship between Cmax and dose, dose normalized Cmax was plotted against dose, and included individual participant values and the geometric means for each dose.
Measured: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Time for Cmax (Tmax) (SAD Period)
Tmax was summarized by dosing regimen and period. It was observed directly from data as time of first occurrence.
Measured: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Terminal Elimination Half-Life ((t½) (SAD Period)
t1/2 was summarized by dosing regimen and period. It was determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.
Measured: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Mean Residence Time (MRT) (SAD Period)
MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from time 0 to infinity.
Measured: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Apparent Volume of Distribution (Vz/F) (SAD Period)
Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Measured: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Apparent Clearance (CL/F) (SAD Period)
CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Measured: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Area Under the Plasma Concentration-Time Profile Over the Dosing Interval τ (AUCτ) (MAD Period Day 1)
AUCτ was summarized by dosing regimen and period. Dosing interval was the interval τ between administration of doses of drug. In this study, the dosing interval was 24 hours for QD dosing and 12 hours for BID dosing. It was determined by linear/log trapezoidal method.
Measured: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Dose Normalized AUCτ (AUCτ[dn]) (MAD Period Day 1)
Area Under the Plasma Concentration-Time Profile over the Dosing interval τ (AUCτ). Dosing interval was the interval τ between administration of doses of drug. In this study, the dosing interval τ was 24 hours for QD dosing and 12 hours for BID dosing.
AUCτ(dn) = AUCτ / Dose. To assess the relationship between the PK parameters and the dose, dose normalized AUCτ was plotted against dose, and included individual participant values and the geometric means for each dose.
Measured: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Cmax (MAD Period Day 1)
Cmax was summarized by dosing regimen and period. It was observed directly from data.
Measured: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Cmax(dn) (MAD Period Day 1)
Cmax(dn) = Cmax / dose. To assess the relationship between Cmax and dose, dose normalized Cmax was plotted against dose, and included individual participant values and the geometric means for each dose.
Measured: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Tmax (MAD Period Day 1)
Tmax was summarized by dosing regimen and period. It was observed directly from data as time of first occurrence.
Measured: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
AUCτ (MAD Period Day 10)
AUCτ was summarized by dosing regimen and period. Dosing interval was the interval τ between administration of doses of drug. In this study, the dosing interval was 24 hours for QD dosing and 12 hours for BID dosing. It was determined by linear/log trapezoidal method.
Measured: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
AUCτ(dn) (MAD Period Day 10)
Area Under the Plasma Concentration-Time Profile over the Dosing interval τ (AUCτ). Dosing interval was the interval τ between administration of doses of drug. In this study, the dosing interval τ was 24 hours for QD dosing and 12 hours for BID dosing.
AUCτ(dn) = AUCτ / Dose. To assess the relationship between the PK parameters and the dose, dose normalized AUCτ was plotted against dose, and included individual participant values and the geometric means for each dose.
Measured: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Cmax (MAD Period Day 10)
Cmax was summarized by dosing regimen and period. It was observed directly from data.
Measured: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Cmax(dn) (MAD Period Day 10)
Cmax(dn) = Cmax / dose. To assess the relationship between Cmax and dose, dose normalized Cmax was plotted against dose, and included individual participant values and the geometric means for each dose.
Measured: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Tmax (MAD Period Day 10)
Tmax was summarized by dosing regimen and period. It was observed directly from data as time of first occurrence.
Measured: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Average Concentration at Steady State (Cav) (MAD Period Day 10)
Cav = AUCτ,ss / τ, where ss means 'at steady state', and where the dosing interval τ was 24 hours for QD dosing and 12 hours for BID dosing. Cav was summarized by dosing regimen and period.
Measured: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Lowest Concentration Observed During the Dosing Interval τ (Cmin) (MAD Period Day 10)
Cmin was observed directly from data. It was summarized by dosing regimen and period. Dosing interval was the interval τ between administration of doses of drug. In this study, the dosing interval τ was 24 hours for QD dosing and 12 hours for BID dosing.
Measured: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Terminal Elimination Half-Life ((t½) (MAD Period Day 10)
t1/2 was summarized by dosing regimen and period. It was determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.
Measured: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24,48,72,96,168 hours post-dose
MRT (MAD Period Day 10)
MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from time 0 to infinity.
Measured: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24,48,72,96,168 hours post-dose
Peak Trough Ratio (PTR) (MAD Period Day 10)
PTR = Cmax,ss / Cmin,ss, where ss means 'at steady state'. It was summarized by dosing regimen and period.
Measured: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Observed Accumulation Ratio Based on AUC (Rac) (MAD Period Day 10)
Rac = AUCτ,ss / AUCτ,sd, where ss means 'at steady state' and sd 'single dose'. In this study, Rac = AUCτ(Day 10) / AUCτ(Day 1). Rac was summarized by dosing regimen and period.
Measured: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Observed Accumulation Ratio Based on Cmax (Rac,Cmax) (MAD Period Day 10)
Rac,Cmax = Cmax,ss / Cmax,sd, where ss means 'at steady state' and sd 'single dose'. In this study, Rac,Cmax = Cmax(Day10) / Cmax(Day 1). Rac,Cmax was summarized by dosing regimen and period.
Measured: Days 1 and 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Vz/F (MAD Period Day 10)
Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Measured: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
CL/F (MAD Period Day 10)
CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Measured: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Cumulative Amount of Drug Recovered Unchanged in Urine From Time 0 to the Dosing Interval τ Hours Post-Dose (Aeτ) (MAD Period Day 10)
Dosing interval was the interval τ between administration of doses of drug. In this study, the dosing interval τ was 24 hours for QD dosing and 12 hours for BID dosing. Aeτ = Sum of [urine concentration * sample volume] for each collection interval. Aer was summarized by dosing regimen and period.
Measured: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Percentage of Dose Recovered Unchanged in Urine From Time 0 to the Dosing Interval τ Hours Post-Dose (Aeτ%) (MAD Period Day 10)
Dosing interval was the interval τ between administration of doses of drug. In this study, the dosing interval τ was 24 hours for QD dosing and 12 hours for BID dosing. Aeτ% = Aeτ / Dose * 100. Aeτ%was summarized by dosing regimen and period.
Measured: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Renal Clearance (Clr) (MAD Period Day 10)
Renal clearance was calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Aeτ) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCτ), where dosing interval is 24 hours for QD dosing and 12 hours for BID dosing.
Measured: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
AUCτ (Psoriasis Cohorts)
AUCτ was summarized by dosing regimen and period. It was determined by linear/log trapezoidal method.
Measured: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
AUCτ(dn) (Psoriasis Cohorts)
AUCτ(dn) = AUCτ / Dose. To assess the relationship between the PK parameters and the dose, dose normalized AUCτ was plotted against dose, and included individual participant values and the geometric means for each dose.
Measured: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
Cmax (Psoriasis Cohorts)
Cmax was summarized by dosing regimen and period. It was observed directly from data.
Measured: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
Cmax(dn) (Psoriasis Cohorts)
Cmax was summarized by dosing regimen and period. It was observed directly from data.
Measured: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
Tmax (Psoriasis Cohorts)
Tmax was summarized by dosing regimen and period. It was observed directly from data as time of first occurrence.
Measured: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
Cav (Psoriasis Cohorts)
Cav = AUCτ,ss / τ, where ss means 'at steady state'. Cav was summarized by dosing regimen and period.
Measured: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
Cmin (Psoriasis Cohorts)
Cmin was observed directly from data. It was summarized by dosing regimen and period.
Measured: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
Terminal Elimination Half-Life ((t½) (Psoriasis Cohorts)
t1/2 was summarized by dosing regimen and period. It was determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.
Measured: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24,168 hours post-dose
MRT (Psoriasis Cohorts)
MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from time 0 to infinity.
Measured: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24,168 hours post-dose
PTR (Psoriasis Cohorts)
PTR = Cmax,ss / Cmin,ss, it was summarized by dosing regimen and period.
Measured: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
Vz/F (Psoriasis Cohorts)
Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Measured: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
CL/F (Psoriasis Cohorts)
CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Measured: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Day 28
Combined assessment of lesion severity and area affected into single score. Body was divided into 4 sections: head, arms, trunk, legs. For each section, percent area of skin involved was estimated: 0= 0% to 6= 90-100%. Severity was estimated by clinical signs: erythema, induration, desquamation; scale: 0= none to 4= maximum. Final PASI = sum of severity parameters for each section*area score*weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4); total possible score range: 0= no disease to 72= maximal disease.
Measured: Baseline and Day 28

Timeline

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

14 Jul 201725 Jan 2019

First posted7 Jul 2017
Study start14 Jul 2017
Primary completion25 Jan 2019
Study completion25 Jan 2019

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 (1)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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: Combination single and multiple ascending dose design. Cohorts of participants are assigned to receive interventions based on acceptable safety, tolerability, and pharmacokinetics of previous dose cohort
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 109 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03210961
Sponsor's protocol ID: C2501001
Status last verified: Mar 2020
First submitted: 3 Jul 2017
Last updated: 31 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

Tehlirian C, Peeva E, Kieras E, Scaramozza M, Roberts ES, Singh RSP, Pradhan V, Banerjee A, Garcet S, Xi L, Gale JD, Vincent MS, Krueger J. Safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of the oral TYK2 inhibitor PF-06826647 in participants with plaque psoriasis: a phase 1, randomised, double-blind, placebo-controlled, parallel-group study. Lancet Rheumatol. 2021 Mar;3(3):e204-e213. doi: 10.1016/S2665-9913(20)30397-0. Epub 2020 Dec 24.
PubMed 38279383

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Efficacy and Flexibility of Tildrakizumab Treatment in Patients With Moderate-to-severe Plaque Psoriasis and High Disease Burden
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Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 3
Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
Plaque Psoriasis
RecruitingPhase 3
A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Clinical Trial of MK-8644 in Healthy Participants and Participants With Psoriasis (MK-8644-001)
Psoriasis, Healthy

All Plaque Psoriasis trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2020. 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-06826647 IN HEALTHY SUBJECTS AND SUBJECTS WITH PLAQUE PSORIASIS
ClinicalTrials.gov ID: NCT03210961
Acronym / sponsor ID: C2501001
Conditions: Plaque Psoriasis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 109 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 14 Jul 2017 (actual)
Primary completion: 25 Jan 2019 (actual)
Study completion: 25 Jan 2019 (actual)
First posted: 7 Jul 2017 (actual)
Results: Posted 31 Mar 2020

Clinical summary

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

This first in human study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-06826647 in healthy subjects and subjects with plaque psoriasis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model description: Combination single and multiple ascending dose design. Cohorts of participants are assigned to receive interventions based on acceptable safety, tolerability, and pharmacokinetics of previous dose cohort

Arm	Type	Receives
PF-06826647 tablet	Experimental	Drug: PF-06826647 tablet
Placebo tablet	Placebo comparator	Other: Placebo tablet
PF-06826647 oral suspension	Experimental	Drug: PF-06826647 oral suspension
Placebo oral solution/suspension	Placebo comparator	Other: Placebo oral solution/suspension

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Healthy male subjects between ages of 18-55 years
Healthy female subjects of non-childbearing potential between the ages of 18-55 years
Body Mass Index (BMI) of 17.5 to 30.5kg/m2; and a total body weight >50kg (110lbs).
No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
(Optional) Japanese subjects who have four Japanese biologic grandparents born in Japan

Key exclusion criteria (9 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)
Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential
Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product
Have a clinically significant infection currently or within 6 months of first dose of study drug
Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis

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-06826647 tabletPF-06826647 tablet for oral administration	Drug	PF-06826647 tablet
PF-06826647 oral suspensionPF-06826647 suspension for oral administration (oral suspension to be administered to the 3mg starting dose cohort only)	Drug	PF-06826647 oral suspension
Placebo oral solution/suspensionplacebo oral solution for the single ascending dose, first cohort only	Other	Placebo oral solution/suspension
Placebo tabletMatching placebo tablet	Other	Placebo tablet

Primary outcome

Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period)
Time frame: Baseline up to Day 8
Maximum absolute values and changes from baseline for vital signs (for supine systolic/diastolic blood pressure [BP] and supine pulse rate [PR]) were summarized descriptively by treatment. Numbers of participants meeting the categorical criteria were provided. Number of participants in PBO SAD cohorts = number of participants in [PBO SAD (3mg, 10mg)] cohorts + number of participants in [PBO SAD -> PBO QD MAD] cohorts.
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period)
Time frame: Baseline up to Day 28
Maximum absolute values and changes from baseline for vital signs (for supine systolic/diastolic blood pressure and supine pulse rate) were summarized descriptively by treatment. Numbers of participants meeting the categorical criteria were provided.
Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
Time frame: Baseline up to Day 56
Maximum absolute values and changes from baseline for vital signs (for supine systolic/diastolic blood pressure and supine pulse rate) were summarized descriptively by treatment. Numbers of participants meeting the categorical criteria were provided.
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period)
Time frame: Baseline up to Day 8
Physical examinations were conducted by a physician, trained physician assistant, or nurse practitioner as acceptable according to local regulation. A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The examination assessed the participants for any potential changes in general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. Findings were considered to be clinically significant based on investigator's decision. Number of participants in PBO SAD cohorts = number of participants in [PBO SAD (3mg, 10mg)] cohorts + number of participants in [PBO SAD -> PBO QD MAD] cohorts.
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (MAD Period)
Time frame: Baseline up to Day 28
Physical examinations were conducted by a physician, trained physician assistant, or nurse practitioner as acceptable according to local regulation. A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The examination assessed the participants for any potential changes in general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. Findings were considered to be clinically significant based on investigator's decision.
Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
Time frame: Baseline up to Day 56
Physical examinations were conducted by a physician, trained physician assistant, or nurse practitioner as acceptable according to local regulation. A full physical examination included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, gastrointestinal, musculoskeletal, and neurological systems. The examination assessed the participants for any potential changes in general appearance, the respiratory and cardiovascular systems, as well as towards participant reported symptoms. Findings were considered to be clinically significant based on investigator's decision.
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-Specified Criteria (SAD Period)
Time frame: Baseline up to Day 8
ECG endpoints and changes from baseline (QTcF, PR and QRS) were summarized descriptively by cohort and treatment using pre-defined categories. Numbers of participants meeting the categorical criteria were provided. All planned and unplanned post-dose time points were counted in these categorical summaries. Categorical summarization criteria for ECG were as follows: 1) QTcF maximum absolute value ≥450 and <480 millisecond (msec), ≥480 and <500 msec. ≥500 msec; 2) QTcF maximum increase ≥30 and <60 msec, ≥60 msec; 3) PR maximum absolute value ≥300 msec; 4) PR maximum increases from baseline ≥25% if baseline >200 msec, ≥50% if baseline ≤200 msec; 5) QRS maximum absolute value ≥140 msec; 6) QRS maximum increase from baseline ≥50%. Number of participants in PBO SAD cohorts = number of participants in [PBO SAD (3mg, 10mg)] cohorts + number of participants in [PBO SAD -> PBO QD MAD] cohorts.
Number of Participants With ECG Data Meeting Pre-Specified Criteria (MAD Period)
Time frame: Baseline up to Day 28
ECG endpoints and changes from baseline (QTcF, PR and QRS) were summarized descriptively by cohort and treatment using pre-defined categories. Numbers of participants meeting the categorical criteria were provided. All planned and unplanned post-dose time points were counted in these categorical summaries. Categorical summarization criteria for ECG were as follows: 1) QTcF maximum absolute value ≥450 and <480 millisecond (msec), ≥480 and <500 msec. ≥500 msec; 2) QTcF maximum increase ≥30 and <60 msec, ≥60 msec; 3) PR maximum absolute value ≥300 msec; 4) PR maximum increases from baseline ≥25% if baseline >200 msec, ≥50% if baseline ≤200 msec; 5) QRS maximum absolute value ≥140 msec; 6) QRS maximum increase from baseline ≥50%.
Number of Participants With ECG Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)
Time frame: Baseline up to Day 56
ECG endpoints and changes from baseline (QTcF, PR and QRS) were summarized descriptively by cohort and treatment using pre-defined categories. Numbers of participants meeting the categorical criteria were provided. All planned and unplanned post-dose time points were counted in these categorical summaries. Categorical summarization criteria for ECG were as follows: 1) QTcF maximum absolute value ≥450 and <480 millisecond (msec), ≥480 and <500 msec. ≥500 msec; 2) QTcF maximum increase ≥30 and <60 msec, ≥60 msec; 3) PR maximum absolute value ≥300 msec; 4) PR maximum increases from baseline ≥25% if baseline >200 msec, ≥50% if baseline ≤200 msec; 5) QRS maximum absolute value ≥140 msec; 6) QRS maximum increase from baseline ≥50%.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Who Withdrew Due to Adverse Events (AEs) (SAD Period)
Time frame: Baseline up to Day 8
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. All events occurring following start of the treatment or increasing in severity were counted as treatment emergent. Events that occurred in a non-treatment period (eg, washout or follow-up) were counted as treatment emergent and attributed to the previous treatment taken. For each event, the investigator pursued and obtained adequate information both to determine the outcome and to assess whether it meets the criteria for classification as an SAE. PBO SAD cohorts = [PBO SAD (3mg, 10mg)] cohorts + [PBO SAD -> PBO QD MAD] cohorts.
Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (MAD Period)
Time frame: Baseline up to Day 28
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. All events occurring following start of the treatment or increasing in severity were counted as treatment emergent. Events that occurred in a non-treatment period (eg, washout or follow-up) were counted as treatment emergent and attributed to the previous treatment taken. For each event, the investigator pursued and obtained adequate information both to determine the outcome and to assess whether it meets the criteria for classification as an SAE.
Number of Participants With TEAEs, SAEs, and Who Withdrew Due to AEs (Psoriasis Cohorts)
Time frame: Baseline up to Day 84
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening (immediate risk of death); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. All events occurring following start of the treatment or increasing in severity were counted as treatment emergent. Events that occurred in a non-treatment period (eg, washout or follow-up) were counted as treatment emergent and attributed to the previous treatment taken. For each event, the investigator pursued and obtained adequate information both to determine the outcome and to assess whether it meets the criteria for classification as an SAE.
Number of Participants With Laboratory Abnormalities (SAD Period)
Time frame: Baseline up to Day 8
Laboratory data were listed and summarized by treatment in accordance with the sponsor reporting standards. Parameters for laboratory abnormalities evaluation included: erythrocyte mean corpuscular volume (Ery. MCV), erythrocyte mean corpuscular hemoglobin (Ery. MCH), reticulocytes/erythrocytes (%), limphocytes, eosinophils, bilirubin, aspartate aminotransferase (AST), urate, high-density lipoproteins (HDL) cholesterol, low-density lipoproteins (LDL) cholesterol, triglycerides, cholesterol, ketones, nitrite, leukocyte esterase, epithelial cells, urinalysis-bacteria. Number of participants in PBO SAD cohorts = number of participants in [PBO SAD (3mg, 10mg)] cohorts + number of participants in [PBO SAD -> PBO QD MAD] cohorts.
Number of Participants With Laboratory Abnormalities (MAD Period)
Time frame: Baseline up to Day 28
Laboratory data were listed and summarized by treatment in accordance with the sponsor reporting standards. Parameters and corresponding primary criteria for laboratory abnormalities evaluation included: Ery. MCV <0.9 × LLN, Ery. Mean corpuscular hemoglobin (Ery. MCH) <0.9 × LLN or >1.1 ULN, reticulocytes/erythrocytes (%) >1.5 × ULN, lymphocytes <0.8 × LLN or >1.2 × ULN, neutrophils <0.8 × LLN, eosinophils >1.2 × ULN, bilirubin >1.5 × ULN, urate >1.2 × ULN, HDL cholesterol <0.8 × LLN, LDL cholesterol >1.2 × ULN, triglycerides >1.3 × ULN, bicarbonate >1.1 × ULN, cholesterol >1.3 × ULN, urine glucose ≥1, urine hemoglobin ≥1, nitrite ≥1, leukocyte esterase ≥1, epithelial cells ≥6/LPF, urinalysis-casts >1/LPF, urinalysis-bacteria >20/HPF, urine 24 hours creatinine >1.1 × ULN.
Number of Participants With Laboratory Abnormalities (Psoriasis Cohorts)
Time frame: Baseline up to Day 56
Laboratory data were listed and summarized by treatment in accordance with the sponsor reporting standards. Parameters and corresponding primary criteria for laboratory abnormalities evaluation included: reticulocytes/erythrocytes (%) >1.5 × ULN, lymphocytes <0.8 × LLN, neutrophils <0.8 × LLN or >1.2 × ULN, eosinophils >1.2 × ULN, bilirubin >1.5 × ULN, alanine aminotransferase (ALT) >3.0 × ULN, creatinine >1.3 × ULN, urate >1.2 × ULN, HDL cholesterol <0.8 × LLN, LDL cholesterol >1.2 × ULN, triglycerides >1.3 × ULN, potassium >1.1 × ULN, bicarbonate >1.1 × ULN, glucose <0.6 × LLN or >1.5 × ULN, Creatine Kinase (CK) >2.0 × ULN, cholesterol >1.3 × ULN, urine glucose ≥1, ketones ≥1, urine hemoglobin ≥1, urine bilirubin ≥1, leukocyte esterase ≥1, epithelial cells ≥6/LPF, urinalysis-bacteria/HPF.
Change in 24 Hour Creatinine Clearance From Day -1 on Day 10 (MAD Period)
Time frame: Day -1 and Day 10
Change in 24-hour creatinine clearance at Day 10 from Day -1 (baseline) during the MAD was presented by treatment group.

47 secondary outcomes

Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) (SAD Period)
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Secondary: Dose Normalized AUCinf (AUCinf[dn]) (SAD Period)
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Area Under the Concentration-Time Profile From Time 0 to 24 Hours (AUC24) (SAD Period)
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) (SAD Period)
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Dose Normalized AUClast (AUClast[dn]) (SAD Period)
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Maximum Plasma Concentration (Cmax) (SAD Period)
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Dose Normalized Cmax (Cmax[dn]) (SAD Period)
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Time for Cmax (Tmax) (SAD Period)
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Terminal Elimination Half-Life ((t½) (SAD Period)
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Mean Residence Time (MRT) (SAD Period)
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Apparent Volume of Distribution (Vz/F) (SAD Period)
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Apparent Clearance (CL/F) (SAD Period)
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24,36,48,72,168 hours post-dose
Area Under the Plasma Concentration-Time Profile Over the Dosing Interval τ (AUCτ) (MAD Period Day 1)
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Dose Normalized AUCτ (AUCτ[dn]) (MAD Period Day 1)
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Cmax (MAD Period Day 1)
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Cmax(dn) (MAD Period Day 1)
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Tmax (MAD Period Day 1)
Time frame: Day 1 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
AUCτ (MAD Period Day 10)
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
AUCτ(dn) (MAD Period Day 10)
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Cmax (MAD Period Day 10)
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Cmax(dn) (MAD Period Day 10)
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Tmax (MAD Period Day 10)
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Average Concentration at Steady State (Cav) (MAD Period Day 10)
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Lowest Concentration Observed During the Dosing Interval τ (Cmin) (MAD Period Day 10)
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Terminal Elimination Half-Life ((t½) (MAD Period Day 10)
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24,48,72,96,168 hours post-dose
MRT (MAD Period Day 10)
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24,48,72,96,168 hours post-dose
Peak Trough Ratio (PTR) (MAD Period Day 10)
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Observed Accumulation Ratio Based on AUC (Rac) (MAD Period Day 10)
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Observed Accumulation Ratio Based on Cmax (Rac,Cmax) (MAD Period Day 10)
Time frame: Days 1 and 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Vz/F (MAD Period Day 10)
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
CL/F (MAD Period Day 10)
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Cumulative Amount of Drug Recovered Unchanged in Urine From Time 0 to the Dosing Interval τ Hours Post-Dose (Aeτ) (MAD Period Day 10)
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Percentage of Dose Recovered Unchanged in Urine From Time 0 to the Dosing Interval τ Hours Post-Dose (Aeτ%) (MAD Period Day 10)
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
Renal Clearance (Clr) (MAD Period Day 10)
Time frame: Day 10 pre-dose, and 0.5,1,2,4,6,8,12,24 hours post-dose
AUCτ (Psoriasis Cohorts)
Time frame: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
AUCτ(dn) (Psoriasis Cohorts)
Time frame: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
Cmax (Psoriasis Cohorts)
Time frame: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
Cmax(dn) (Psoriasis Cohorts)
Time frame: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
Tmax (Psoriasis Cohorts)
Time frame: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose
Cav (Psoriasis Cohorts)
Time frame: Day 28 pre-dose, and 0.5,1,2,4,6,8,12,16,24 hours post-dose

Results and safety

Results posted to the registry on 31 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo (PBO) SAD (3 Milligrams [mg], 10 mg)	4	4
PBO SAD Followed by (->) PBO QD MAD	9	9
PBO QD MAD Japanese Cohort (JP)	1	1
PBO Twice Daily (BID)	2	1
PF-06826647 3 mg SAD	6	6
PF-06826647 10 mg SAD	6	6
PF-06826647 30 mg SAD -> 30 mg QD MAD	8	7
PF-06826647 100 mg SAD -> 100 mg QD MAD	7	7
PF-06826647 400 mg SAD -> 400 mg QD MAD	8	8
PF-06826647 1600 mg SAD -> 1200 mg QD MAD	6	6
PF-06826647 200 mg BID	7	6
PF-06826647 400 mg QD MAD JP	5	5
PBO QD Psoriasis Cohort (PSO)	14	12
PF-06826647 400 mg QD PSO	15	11
PF-06826647 100 mg QD PSO	11	9

Primary outcome: Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period)

Time frame: Baseline up to Day 8. Count of participants. Unit: Participants

Measure	PBO SAD n = 13	PF-06826647 3 mg SAD n = 6	PF-06826647 10 mg SAD n = 6	PF-06826647 30 mg SAD n = 8	PF-06826647 100 mg SAD n = 7	PF-06826647 400 mg SAD n = 8	PF-06826647 1600 mg SAD n = 6
Supine diastolic BP Value <50 mmHg	2	2	1	0	1	0	0
Supine diastolic BP Change (Chg) ≥20 mmHg increase	3	1	1	2	1	0	2
Supine diastolic BP Chg ≥20 mmHg decrease	2	1	2	1	2	1	0
Supine pulse rate Value <40 beats per minute (bpm)	1	0	0	0	0	0	0
Supine pulse rate Value >120 bpm	0	0	0	0	0	0	0
Supine systolic BP Value <90mmHg	1	1	2	1	0	0	0
Supine systolic BP Chg ≥30 mmHg increase	2	0	0	0	0	0	0
Supine systolic BP Chg ≥30mmHg decrease	2	1	1	0	1	0	0

Population analysed: The analysis population included the healthy participants who received study treatment and who had the safety parameters in the SAD Period. MAD and Psoriasis Cohorts data were not included.

Primary outcome: Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Multiple Ascending Dose [MAD] Period)

Time frame: Baseline up to Day 28. Count of participants. Unit: Participants

Measure	PBO QD MAD (JP PBO Included) n = 9	PF-06826647 30 mg QD MAD n = 6	PF-06826647 100 mg QD MAD n = 6	PF-06826647 400 mg QD MAD n = 6	PF-06826647 1200 mg QD MAD n = 5	PF-06826647 200 mg BID n = 7	PF-06826647 400 mg QD MAD JP n = 5
Supine diastolic BP Value < 50 mmHg	1	0	0	1	0	1	1
Supine diastolic BP Chg ≥ 20 mmHg increase	1	1	1	1	0	3	0
Supine diastolic BP Chg ≥ 20 mmHg decrease	4	2	1	1	1	1	2
Supine pulse rate Value < 40 bpm	0	0	0	0	0	0	0
Supine pulse rate Value > 120 bpm	0	0	0	0	0	0	0
Supine systolic blood pressure Value < 90 mmHg	1	0	0	0	0	0	1
Supine systolic BP Chg ≥ 30 mmHg increase	1	1	1	2	0	0	0
Supine systolic BP Chg ≥ 30 mmHg decrease	0	1	1	0	0	0	0

Population analysed: The analysis population included the healthy participants who received study treatment in the MAD Period. The PBO QD MAD sequence is comprised of both non-Japanese and Japanese participants. The non-Japanese participants had completed the SAD period and continued into the MAD period. The Japanese participants took part only in the MAD period.

Primary outcome: Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Psoriasis Cohorts)

Time frame: Baseline up to Day 56. Count of participants. Unit: Participants

Measure	PBO QD PSO n = 14	PF-06826647 400 mg QD PSO n = 15	PF-06826647 100 mg QD PSO n = 11
Supine diastolic blood pressure Value < 50 mmHg	0	1	1
Supine diastolic BP Chg ≥ 20 mmHg increase	0	3	5
Supine diastolic BP Chg ≥ 20 mmHg decrease	6	7	4
Supine pulse rate Value < 40 bpm	0	0	0
Supine pulse rate Value > 120 bpm	0	0	0
Supine systolic BP Value < 90 mmHg	1	0	0
Supine systolic BP Chg ≥ 30 mmHg increase	0	1	2
Supine systolic BP Chg ≥ 30 mmHg decrease	6	5	1

Population analysed: The analysis population included the psoriasis participants who received study treatment and who had the safety parameters in the Psoriasis Cohorts. Data in SAD/MAD Periods were not included.

Primary outcome: Number of Participants With Physical Examination Data Meeting Pre-Specified Criteria (SAD Period)

Time frame: Baseline up to Day 8. Count of participants. Unit: Participants

Measure	PBO SAD n = 13	PF-06826647 3 mg SAD n = 6	PF-06826647 10 mg SAD n = 6	PF-06826647 30 mg SAD n = 8	PF-06826647 100 mg SAD n = 7	PF-06826647 400 mg SAD n = 8	PF-06826647 1600 mg SAD n = 6
cardiovascular	0	0	0	0	0	0	0
ears	0	0	0	0	0	0	0
eyes	0	0	0	0	0	0	0
gastrointestinal	0	0	0	0	0	0	0
general appearance	0	0	0	0	0	0	0
head	0	0	0	0	0	0	0
heart	0	0	0	0	0	0	0
lungs	0	0	0	0	0	0	0

47 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Day 8 for SAD Cohorts, which included PF-06826647 3mg, 10mg, 30mg, 100mg, 400mg, and 1600mg SD cohorts as well as placebo matching each SAD cohort. Baseline up to Day 28 for MAD Cohorts, which included PF-06826647 30mg, 100mg, 400mg, 1200mg QD, 200mg BID, 400mg QD JP, as well as placebo matching each MAD cohort. Baseline up to Day 84 for Psoriasis Cohorts, which included PF-06826647 400mg and 100mg QD cohorts, as well as placebo matching each psoriasis cohort.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo SAD	0 of 13 (0%)	1 of 13 (7.7%)	0 of 13
Placebo QD MAD (JP Placebo Included)	0 of 9 (0%)	2 of 9 (22.2%)	0 of 9
Placebo BID	0 of 2 (0%)	0 of 2 (0%)	0 of 2
PF-06826647 3 mg SAD	0 of 6 (0%)	0 of 6 (0%)	0 of 6
PF-06826647 10 mg SAD	0 of 6 (0%)	0 of 6 (0%)	0 of 6
PF-06826647 30 mg SAD	0 of 8 (0%)	0 of 8 (0%)	0 of 8
PF-06826647 30 mg QD MAD	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
PF-06826647 100 mg SAD	0 of 7 (0%)	1 of 7 (14.3%)	0 of 7
PF-06826647 100 mg QD MAD	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
PF-06826647 400 mg SAD	0 of 8 (0%)	0 of 8 (0%)	0 of 8
PF-06826647 400 mg QD MAD	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
PF-06826647 1600 mg SAD	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
PF-06826647 1200 mg QD MAD	0 of 5 (0%)	1 of 5 (20%)	0 of 5
PF-06826647 200 mg BID	0 of 7 (0%)	3 of 7 (42.9%)	0 of 7
PF-06826647 400 mg QD MAD JP	0 of 5 (0%)	1 of 5 (20%)	0 of 5
Placebo QD PSO	0 of 14 (0%)	7 of 14 (50%)	0 of 14
PF-06826647 400 mg QD PSO	0 of 15 (0%)	12 of 15 (80%)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38279383Tehlirian C, Peeva E, Kieras E, Scaramozza M, Roberts ES, Singh RSP, Pradhan V, Banerjee A, Garcet S, Xi L, Gale JD, Vincent MS, Krueger J. Safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of the oral TYK2 inhibitor PF-06826647 in participants with plaque psoriasis: a phase 1, randomised, double-blind, placebo-controlled, parallel-group study. Lancet Rheumatol. 2021 Mar;3(3):e204-e213. doi: 10.1016/S2665-9913(20)30397-0. Epub 2020 Dec 24.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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-06826647 tablet and PF-06826647 oral suspension 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 10 inclusion and 9 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 31 Mar 2020. 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 31 Mar 2020). 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?

Number of Participants With Vital Signs Data Meeting Pre-Specified Criteria (Single Ascending Dose [SAD] Period) (time frame: Baseline up to Day 8). The study lists 16 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 NCT03210961, which also lists 1 linked publication.

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 31 Mar 2020.