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
Study type: Interventional
Phase: Phase 1

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.
    

Detailed description: 
      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK)
      of PF-06751979 following oral doses in healthy adult and healthy elderly subjects at higher
      doses than previously administered. Such characteristics will enable the design of future
      clinical trials in patient population, in the effort to optimize the efficacy of PF-06751979,
      as well as to establish safety margins in humans. Inclusion of healthy elderly subjects will
      be optional, but can provide additional safety and tolerability information in the age range
      of the target population while confirming the PK of PF-06751979 in these subjects for future
      clinical trials in the Alzheimer's disease patient population.

      The Primary Objective is to evaluate the safety and tolerability of single and multiple
      ascending oral doses of PF-06751979 in healthy adult subjects. Secondary Objectives are to
      characterize the pharmacokinetics of PF-06751979 in: plasma following single and multiple
      ascending oral dose administration in healthy adult subjects and urine following multiple
      ascending oral dose administration in healthy adult subjects. An additional secondary
      objective is to evaluate the effect of multiple oral doses of PF 06751979 on CSF A-beta
      fragments in healthy adult subjects.

      This study is divided into three parts: Part A - Single ascending doses (SAD) healthy adult
      subjects (18-55 years); Part B - Multiple ascending doses (MAD) in healthy adult subjects
      (18-55 years); Part C - Multiple doses (MD) in healthy elderly subjects (60-85 years). Study
      Parts may be run in a staggered fashion; Part C of the study may commence after satisfactory
      review of relevant data from Parts A and B.
    

Intervention name(s): 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 type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 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)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Safety; Tolerability; Pharmacokinetics; Alzheimer's disease