A Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Study Of PF-06700841, With Bioavailability/Food Effect Investigation
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: PF-06700841 oral solution/suspension; Placebo; PF-06700841 tablet
Intervention description: Oral solution or suspension of study drug PF-06700841 (once daily or twice daily during multiple dosing periods); Matching placebo given during the single ascending and multiple dose periods; PF-06700841 tablet formulation administered during the bioavailability / food effect investigation
Intervention MeSH terms: PF-06700841
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 96.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

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).
    

Eligibility criteria:

        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