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Trial record 2 of 2 for:    PF-06826647 | psoriasis

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

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ClinicalTrials.gov Identifier: NCT03210961
Recruitment Status : Completed
First Posted : July 7, 2017
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: PF-06826647 tablet Drug: PF-06826647 oral suspension Other: Placebo oral solution/suspension Other: Placebo tablet Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Combination single and multiple ascending dose design. Cohorts of participants are assigned to receive interventions based on acceptable safety, tolerability, and pharmacokinetics of previous dose cohort
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double blind treatment
Primary Purpose: Treatment
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
Actual Study Start Date : July 14, 2017
Actual Primary Completion Date : January 25, 2019
Actual Study Completion Date : January 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: PF-06826647 tablet Drug: PF-06826647 tablet
PF-06826647 tablet for oral administration

Placebo Comparator: Placebo tablet Other: Placebo tablet
Matching placebo tablet

Experimental: PF-06826647 oral suspension Drug: PF-06826647 oral suspension
PF-06826647 suspension for oral administration (oral suspension to be administered to the 3mg starting dose cohort only)

Placebo Comparator: Placebo oral solution/suspension Other: Placebo oral solution/suspension
placebo oral solution for the single ascending dose, first cohort only




Primary Outcome Measures :
  1. Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) [ Time Frame: Baseline (Day 0) up to study day 28 for healthy participants ]
  2. Number of Participants With Clinical Laboratory Abnormalities [ Time Frame: Baseline up to study day 28 for healthy participants ]
    Clinical laboratory assessments include: including hematology, fibrinogen, chemistry, fasting glucose, lipids, urinalysis

  3. Number of Participants With Abnormal Electrocardiogram (ECG) [ Time Frame: Baseline up to study day 28 for healthy participants ]
    Criteria for ECG abnormalities: maximum PR interval >=300 milliseconds (msec) and maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) >=25 percent (%) for baseline value of >200 msec and Pctchg>=50% for baseline value of <=200 msec for PR interval, maximum QRS interval >=140 msec and a maximum IFB: Pctchg>=50%, maximum QTCF interval (Fridericia's Correction) of 450 msec to <480 msec, 480 msec to <500 msec or >=500 msec and a maximum change of <=30change<60 or >=60 msec from baseline.

  4. Number of Participants With Categorical Vital Signs Data [ Time Frame: Baseline up to study day 28 for healthy participants ]
  5. Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) [ Time Frame: Baseline (Day 0) baseline up to study day 84 for psoriasis participants ]
  6. Number of Participants With Clinical Laboratory Abnormalities [ Time Frame: Baseline up to study day 56 for psoriasis participants ]
    Clinical laboratory assessments include: including hematology, fibrinogen, chemistry, fasting glucose, lipids, urinalysis

  7. Number of Participants With Abnormal Electrocardiogram (ECG) [ Time Frame: Baseline up to study day 56 for psoriasis participants ]
    Criteria for ECG abnormalities: maximum PR interval >=300 milliseconds (msec) and maximum increase PR interval increase from baseline (IFB): percent change (Pctchg) >=25 percent (%) for baseline value of >200 msec and Pctchg>=50% for baseline value of <=200 msec for PR interval, maximum QRS interval >=140 msec and a maximum IFB: Pctchg>=50%, maximum QTCF interval (Fridericia's Correction) of 450 msec to <480 msec, 480 msec to <500 msec or >=500 msec and a maximum change of <=30change<60 or >=60 msec from baseline.

  8. Number of Participants With Categorical Vital Signs Data [ Time Frame: Baseline up to study day 56 for psoriasis participants ]

Secondary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 168 hours post-dose ]
    Samples for pharmacokinetics collected during the single ascending dose period (healthy participants)

  2. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Pre-dose on study days 1, 2, 4, 6, 8, 10, and day 10 at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 168 hours post dose ]
    Samples collected for pharmacokinetics during the multiple ascending dose period (healthy participants)

  3. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Pre-dose on study days 1, 7, 14, 21, 28, and day 28 at 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post dose ]
    Samples for pharmacokinetics collected during once daily dosing for 28 days in psoriasis participants

  4. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 168 hours post-dose ]
    Samples for pharmacokinetics collected during the single ascending dose period (healthy participants)

  5. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Pre-dose on study days 1, 2, 4, 6, 8, 10, and day 10 at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 168 hours post dose ]
    Samples collected for pharmacokinetics during the multiple ascending dose period (healthy participants)

  6. Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Pre-dose on study days 1, 7, 14, 21, 28, and day 28 at 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post dose ]
    Samples for pharmacokinetics collected during once daily dosing for 28 days in psoriasis participants

  7. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 168 hours post-dose ]
    Samples for pharmacokinetics collected during the single ascending dose period (healthy participants)

  8. Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 168 hours post- ]
    Samples for pharmacokinetics collected during the single ascending dose period (healthy participants)

  9. Dose Normalized Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 168 hours post-dose ]
    Samples for pharmacokinetics collected during the single ascending dose period (healthy participants)

  10. Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 168 hours post-dose ]
    Samples for pharmacokinetics collected during the single ascending dose period (healthy participants)

  11. Dose Normalized Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Pre-dose on study days 1, 2, 4, 6, 8, 10, and day 10 at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 168 hours post dose ]
    Samples collected for pharmacokinetics during the multiple ascending dose period (healthy participants)

  12. Dose Normalized Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Pre-dose on study days 1, 7, 14, 21, 28, and day 28 at 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post dose ]
    Samples for pharmacokinetics collected during once daily dosing for 28 days in psoriasis participants

  13. Area Under the Curve from Time Zero to end of dosing interval (AUCtau) [ Time Frame: Pre-dose on study days 1, 2, 4, 6, 8, 10, and day 10 at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 168 hours post dose ]
    Samples collected for pharmacokinetics during the multiple ascending dose period (healthy participants)

  14. Area Under the Curve from Time Zero to end of dosing interval (AUCtau) [ Time Frame: Pre-dose on study days 1, 7, 14, 21, 28, and day 28 at 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post dose ]
    Samples for pharmacokinetics collected during once daily dosing for 28 days in psoriasis participants

  15. Plasma Decay Half-Life (t1/2) [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 168 hours post-dose ]
    Samples for pharmacokinetics collected during the single ascending dose period (healthy participants)

  16. Plasma Decay Half-Life (t1/2) [ Time Frame: Pre-dose on study days 1, 2, 4, 6, 8, 10, and day 10 at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 168 hours post dose ]
    Samples collected for pharmacokinetics during the multiple ascending dose period (healthy participants)

  17. Plasma Decay Half-Life (t1/2) [ Time Frame: Pre-dose on study days 1, 7, 14, 21, 28, and day 28 at 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post dose ]
    Samples for pharmacokinetics collected during once daily dosing for 28 days in psoriasis participants

  18. Apparent Volume of Distribution (Vz/F) [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 168 hours post-dose ]
    Samples for pharmacokinetics collected during the single ascending dose period (healthy participants)

  19. Apparent Volume of Distribution (Vz/F) [ Time Frame: Pre-dose on study days 1, 2, 4, 6, 8, 10, and day 10 at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 168 hours post dose ]
    Samples collected for pharmacokinetics during the multiple ascending dose period (healthy participants)

  20. Apparent Volume of Distribution (Vz/F) [ Time Frame: Pre-dose on study days 1, 7, 14, 21, 28, and day 28 at 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post dose ]
    Samples for pharmacokinetics collected during once daily dosing for 28 days in psoriasis participants

  21. Mean residence time [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 168 hours post-dose ]
    Samples for pharmacokinetics collected during the single ascending dose period (healthy participants)

  22. Mean residence time [ Time Frame: Pre-dose on study days 1, 2, 4, 6, 8, 10, and day 10 at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 168 hours post dose ]
    Samples collected for pharmacokinetics during the multiple ascending dose period (healthy participants)

  23. Mean residence time [ Time Frame: Pre-dose on study days 1, 7, 14, 21, 28, and day 28 at 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post dose ]
    Samples for pharmacokinetics collected during once daily dosing for 28 days in psoriasis participants

  24. Minimum Observed Plasma Trough Concentration (Cmin) [ Time Frame: Pre-dose on study days 1, 2, 4, 6, 8, 10, and day 10 at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 168 hours post dose ]
    Samples collected for pharmacokinetics during the multiple ascending dose period (healthy participants)

  25. Minimum Observed Plasma Trough Concentration (Cmin) [ Time Frame: Pre-dose on study days 1, 7, 14, 21, 28, and day 28 at 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post dose ]
    Samples for pharmacokinetics collected during once daily dosing for 28 days in psoriasis participants

  26. Average Plasma Concentration [ Time Frame: Pre-dose on study days 1, 2, 4, 6, 8, 10, and day 10 at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 168 hours post dose ]
    Samples collected for pharmacokinetics during the multiple ascending dose period (healthy participants)

  27. Average Plasma Concentration [ Time Frame: Pre-dose on study days 1, 7, 14, 21, 28, and day 28 at 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post dose ]
    Samples for pharmacokinetics collected during once daily dosing for 28 days in psoriasis participants

  28. Observed Accumulation Ratio (Rac) [ Time Frame: Pre-dose on study days 1, 2, 4, 6, 8, 10, and day 10 at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 168 hours post dose ]
    Samples collected for pharmacokinetics during the multiple ascending dose period (healthy participants)

  29. Observed Accumulation Ratio for Cmax (Rac Cmax) [ Time Frame: Pre-dose on study days 1, 2, 4, 6, 8, 10, and day 10 at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 168 hours post dose ]
    Samples collected for pharmacokinetics during the multiple ascending dose period (healthy participants)

  30. Peak to Trough Ratio [ Time Frame: Pre-dose on study days 1, 2, 4, 6, 8, 10, and day 10 at 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72, 96, 168 hours post dose ]
    Samples collected for pharmacokinetics during the multiple ascending dose period (healthy participants)

  31. Peak to Trough Ratio [ Time Frame: Pre-dose on study days 1, 7, 14, 21, 28, and day 28 at 0.5, 1, 2, 4, 6, 8, 12, 16, 24 hours post dose ]
    Samples for pharmacokinetics collected during once daily dosing for 28 days in psoriasis participants

  32. Change from baseline in psoriasis area and severity index(PASI)score at Day28 [ Time Frame: Change from baseline at study day 28 ]
    PASI will be performed in psoriasis participants only



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Healthy Participants:

Inclusion Criteria:

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

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
  • Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential
  • Fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product
  • Have a clinically significant infection currently or within 6 months of first dose of study drug

Psoriasis Participants:

Inclusion Criteria:

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

Exclusion Criteria:

  • Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210961


Locations
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United States, California
Anaheim Clinical Trials, LLC
Anaheim, California, United States, 92801
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03210961     History of Changes
Other Study ID Numbers: C2501001
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Pharmaceutical Solutions