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

NCT03210961

Last updated date
Study Location
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Plaque Psoriasis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Pfizer Clinical Trials Contact Center

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[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE A First in Human Study to Evaluate Safety, Tolerability, and Pharmacology of PF-06826647 in Healthy Subjects and Subjects With Plaque Psoriasis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE Plaque Psoriasis
Intervention  ICMJE
  • Drug: PF-06826647 tablet
    PF-06826647 tablet for oral administration
  • Drug: PF-06826647 oral suspension
    PF-06826647 suspension for oral administration (oral suspension to be administered to the 3mg starting dose cohort only)
  • Other: Placebo oral solution/suspension
    placebo oral solution for the single ascending dose, first cohort only
  • Other: Placebo tablet
    Matching placebo tablet
Study Arms  ICMJE
  • Experimental: PF-06826647 tablet
    Intervention: Drug: PF-06826647 tablet
  • Placebo Comparator: Placebo tablet
    Intervention: Other: Placebo tablet
  • Experimental: PF-06826647 oral suspension
    Intervention: Drug: PF-06826647 oral suspension
  • Placebo Comparator: Placebo oral solution/suspension
    Intervention: Other: Placebo oral solution/suspension
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2018)
109
Original Estimated Enrollment  ICMJE
 (submitted: July 5, 2017)
90
Actual Study Completion Date  ICMJE January 25, 2019
Actual Primary Completion Date January 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03210961
Other Study ID Numbers  ICMJE C2501001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP