An open-label study to understand the effect of different modified release and immediate release formulations on plasma PF-06865571 concentrations after single oral administration under fed conditions

Inclusion Criteria:

• Healthy males and female of non-childbearing potential
• Age of 18-55, inclusive
• Body Mass Index 17.5 to 30.5 kg/m2, inclusive
• Body weight >50 kg
• Not on any prescription or non-prescription drugs within 7 days or 5 half-lives prior to first dose.

Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

• Any condition possibly affecting drug absorption (eg, gastrectomy).

• A positive urine drug test.

• History of regular alcohol consumption exceeding 14 drinks/week for female subjects or 21 drinks/week for male subjects (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months before screening.

• Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer).

• Screening supine BP >=140 mm Hg (systolic) or >= 90 mm Hg (diastolic), following at least 5 minutes of supine rest.

• Screening supine 12 lead ECG demonstrating a corrected QT (QTc) interval >450 msec or a QRS interval >120 msec.

• Subjects with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:

  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level >=1.25 × upper limit of normal (ULN);
  • Total bilirubin level >=1.5 × ULN; subjects with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is =\

Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests