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

NCT02310750

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

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

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By email

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[email protected]

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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
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Key Inclusion Criteria for Healthy Subject Cohorts:

- Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive

- No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)

Key Inclusion Criteria for Psoriasis Subject Cohorts:

- Male subjects and/or female subjects of non-childbearing potential with a diagnosis of plaque psoriasis who are between the ages of 18 and 65 years, inclusive

- Have a diagnosis of plaque psoriasis for at least 6 months prior to first study dose

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


Key Exclusion Criteria for Healthy Subject Cohorts:


- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing)


- Males of childbearing potential who are unwilling or unable to use a highly effective
method of contraception as outlined in this protocol for the duration of the study and
for at least 28 days after the last dose of investigational product


Key Exclusion Criteria for Psoriasis Subject Cohorts:


- Currently have non plaque forms of psoriasis, (eg, erythrodermic, guttate, or pustular
psoriasis).


- Have current drug induced psoriasis, eg, a new onset of psoriasis or an exacerbation
of psoriasis from beta blockers, calcium channel blockers, antimalarial drugs or
lithium


- Males of childbearing potential who are unwilling or unable to use a highly effective
method of contraception as outlined in this protocol for the duration of the study and
for at least 28 days after the last dose of investigational product

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

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[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06700841, With Bioavailability/Food Effect Investigation
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-06700841 In Healthy Subjects And Subjects With Plaque Psoriasis And Bioavailability Of A Tablet Formulation Relative To Suspension Formulation And The Effect Of Food On A Tablet Formulation Of Pf-06700841
Brief Summary The main purpose of the study is to determine if PF-06700841 is safe and well tolerated when administered to humans. A secondary purpose is to assess what the body does to PF-06700841 and to assess what PF-06700841 does to the body when given as single and multiple doses. The pharmacokinetic properties of different forms of PF-06700841 may be studied (tablet and solution/suspension forms).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Condition  ICMJE Plaque Psoriasis
Intervention  ICMJE
  • Drug: PF-06700841 oral solution/suspension
    Oral solution or suspension of study drug PF-06700841 (once daily or twice daily during multiple dosing periods)
  • Other: Placebo
    Matching placebo given during the single ascending and multiple dose periods
  • Drug: PF-06700841 tablet
    PF-06700841 tablet formulation administered during the bioavailability / food effect investigation
Study Arms  ICMJE
  • Experimental: PF-06700841 Oral Solution/Suspension
    Intervention: Drug: PF-06700841 oral solution/suspension
  • Experimental: PF-06700841 Tablet
    Intervention: Drug: PF-06700841 tablet
  • Placebo Comparator: Placebo
    Oral placebo comparator for the healthy subject single and multiple ascending dose periods, and the psoriasis multiple dose period. No placebo used for the bioavailability investigation.
    Intervention: Other: Placebo
Publications * Banfield C, Scaramozza M, Zhang W, Kieras E, Page KM, Fensome A, Vincent M, Dowty ME, Goteti K, Winkle PJ, Peeva E. The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a TYK2/JAK1 Inhibitor (PF-06700841) in Healthy Subjects and Patients With Plaque Psoriasis. J Clin Pharmacol. 2018 Apr;58(4):434-447. doi: 10.1002/jcph.1046. Epub 2017 Dec 21.

*   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: February 17, 2016)
96
Original Estimated Enrollment  ICMJE
 (submitted: December 4, 2014)
104
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Key Inclusion Criteria for Healthy Subject Cohorts:

  • Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive
  • No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)

Key Inclusion Criteria for Psoriasis Subject Cohorts:

  • Male subjects and/or female subjects of non-childbearing potential with a diagnosis of plaque psoriasis who are between the ages of 18 and 65 years, inclusive
  • Have a diagnosis of plaque psoriasis for at least 6 months prior to first study dose

Exclusion Criteria:

Key Exclusion Criteria for Healthy Subject Cohorts:

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

Key Exclusion Criteria for Psoriasis Subject Cohorts:

  • Currently have non plaque forms of psoriasis, (eg, erythrodermic, guttate, or pustular psoriasis).
  • Have current drug induced psoriasis, eg, a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, antimalarial drugs or lithium
  • Males of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older 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 NCT02310750
Other Study ID Numbers  ICMJE B7931001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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 January 2017

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