- 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.
- 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 - Fertile male subjects who are unwilling or unable to use a highly effective method of - Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more - History of sensitivity to heparin or heparin induced thrombocytopenia only if heparin - History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive - Unwilling or unable to comply with Lifestyle Requirements in the protocol - Subjects who are investigator site staff members directly involved in the conduct of - Other acute or chronic medical or psychiatric condition including recent (within the - Subjects who have previously participated in prior studies with PF 06865571 as the
may have direct bilirubin measured and would be eligible for this study provided
the direct bilirubin level is =
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.
within 60 days prior to dosing.
is used to flush any intravenous catheters in the study.
testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody
(HepBcAb), or hepatitis C antibody (HCVAb).
the study and their family members, site staff members otherwise supervised by the
investigator, or subjects who are Pfizer employees, including their family members,
directly involved in the conduct of the study.
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.
investigational product.