First-In-Human Study Of Single And Multiple Ascending Doses Of PF-06751979
Condition: Healthy Subjects
Intervention: PF-06751979 single ascending dose; Placebo single dose; PF-06751979 multiple ascending dose; Placebo multiple dose; PF-06751979 multiple dose; PF-06751979 multiple dose
Intervention description: PF-06751979 administered as a single dose (solution/suspension) in cross-over fashion. Each subject may receive up to 4 study treatments (placebo and up to 3 doses of PF-06751979). The dose levels are 3 mg, 12 mg, 40 mg, 160 mg.; Matched Placebo solution/suspension administered as single dose.; PF-06751979 (solution/suspension) administered daily for 14 consecutive days to parallel cohorts. The dose levels are 5 mg, 15 mg, 50 mg.; Matched Placebo (solution/suspension)administered daily for 14 consecutive days.; PF-06751979 (solution/suspension) administered daily for 14 consecutive days. The dose level is 50 mg.; Matched Placebo (suspension/solution) administered daily for 14 consecutive days to parallel cohorts.
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Alzheimer's disease

Summary:

      The purpose of this study is to evaluate the safety, tolerability, PK and PD of PF-06751979
      following oral doses in healthy adult and healthy elderly subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and/or female subjects of non-childbearing potential between the ages of
             18 and 55 years or between the ages of 60 and 85 years, inclusive.

          -  Body Mass Index (BMI) of 17.5 to 32 kg/m2; and a total body weight >50 kg (110 lbs) at
             Screening.

          -  Evidence of a personally signed and dated informed consent document indicating that
             the subject or a legally acceptable representative has been informed of all pertinent
             aspects of the study.

        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 the time of dosing).

          -  Male subjects with partners currently pregnant; male subjects able to father children
             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.

          -  Unwilling or unable to comply with the Lifestyle Guidelines described in this
             protocol.

          -  Subjects who are investigational site staff members directly involved in the conduct
             of the study and their family members, site staff members otherwise supervised by the
             Investigator, or subjects who are Pfizer employees directly involved in the conduct of
             the study.

          -  Any severe acute or chronic medical or psychiatric condition including recent (within
             the past year) or active suicidal ideation or behavior or laboratory abnormality that
             may increase the risk associated with study participation or investigational product
             administration or may interfere with the interpretation of study results and, in the
             judgment of the Investigator, would make the subject inappropriate for entry into this
             study.