First In Human, Single Escalating Oral Dose Study Of PF-06882961 In Healthy Adult Subjects

Primary Purpose: Basic Science

• Drug: PF-06882961
  
  Single Ascending Doses of PF-06882961 from 3mg to TBD mg.
• Other: Placebo
  
  Placebo Single Dose

• Experimental: Cohort 1
  
  Single Ascending Dose in crossover design with placebo substitution. Administration under fed or fasted conditions as tablet or solution formulation. At least 7 days washout between doses in an individual subject.
  Interventions:
  

  • Drug: PF-06882961
  • Other: Placebo
• Experimental: Cohort 2
  
  Single Ascending Dose in crossover design with placebo substitution. Administration under fed or fasted conditions as tablet or solution formulation. At least 7 days washout between doses in an individual subject.
  Interventions:
  

  • Drug: PF-06882961
  • Other: Placebo
• Experimental: Cohort 3 (optional)
  
  Single Ascending Dose administration under fed or fasted conditions as tablet or solution formulation. At least 7 days washout between doses in an individual subject.
  Interventions:
  

  • Drug: PF-06882961
  • Other: Placebo

Inclusion Criteria:

• Healthy female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive
• Body mass index (BMI) within 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb)
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal (including pancreatitis), cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing.
• Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of IP (whichever is longer).
• Fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 28 days after the last dose.
• Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose