Clinical Trial In Healthy Volunteers And Health Elderly Volunteers To Evaluate The Safety, Tolerability And Blood Concentration After Single And Multiple Escalating Oral Doses Of PF-06751979.
Condition: Healthy Subjects
Intervention: PF-06751979 single dose; Placebo single dose; PF-06751979 multiple ascending dose; Placebo multiple ascending dose; PF-06751979 multiple dose; Placebo multiple elderly dose
Intervention description: PF-06751979 administered as a single dose suspension in cross-over fashion. Each subject may receive up to 4 study treatments (placebo and up to 3 doses of PF 06751979). The planned dose levels are 200 mg, 400 mg, 700 mg, 200 mg fed (these doses are subject to change based on emerging data).; Matched Placebo suspension administered as single dose; PF-06751979 suspension administered daily for 14 consecutive days to parallel cohorts. The planned dose levels are mg, 100 mg, 200 mg, 340 mg (these are subject to change based on emerging data).; Matched placebo suspension administered daily for 14 consecutive days.; PF-06751979 suspension administered daily for 14 consecutive days. The planned dose level is 340 mg (this is subject to change based on emerging data).; Multiple dose administration to Healthy Elderly Subjects (Placebo)
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Safety; Tolerability; Pharmacokinetics; Alzheimer's disease

Summary:

      This study will test the safety, tolerability and blood concentrations of single and multiple
      oral doses of PF-06751979 in health subjects and healthy elderly subjects. PF-06751979 is
      being developed for the treatment of Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy female subjects of non childbearing potential and male subjects.

          -  Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 (32 kg/m2 for healthy elderly); 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.

          -  Additional criterion for subjects of Japanese descent who may be enrolled in Part B
             (multiple ascending dose cohorts in healthy subjects): Japanese subjects who have four
             Japanese 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 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 the 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 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.