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Single Dose Study to Assess the Safety, Tolerability and Pharmacokinetics(PK) of PF-06865571

Last updated on February 20, 2019

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Study Location
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511 United States
Contact
1-800-254-6398
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Healthy males and female of non-childbearing potential;

- Age of 18-55, inclusive;

- Body Mass Index 22.5 to 35.4 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Evidence of history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergises, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing)

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

- A positive urine drug test.

- History of regular alcohol consumption exceeding 7 drinks/week for female subjects or
14 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).

- Fertile male subjects 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.

- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 60 days prior to dosing.

- History of sensitivity to heparin or heparin induced thrombocytopenia.

- History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive
testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody
(HepBcAb), or hepatitis C antibody (HCVAb).

- Fertile male subjects 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.

- 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: (1)Aspartate aminotransferase (AST), alanine
aminotransferase (ALT) level, or total bilirubin > upper limit of normal (ULN); (2)
For optional Cohort 3 only, AST or ALT greater or equal to 1.5 × ULN, provided that
data from Cohorts 1 and 2 support this limit; (3) ? 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 less than or equal to ULN plus ALT and
AST are less than or equal to ULN plus alkaline phosphatase, hemoglobin, and
reticulocyte count are all less than or equal to ULN.

- Unwilling or unable to comply with the criteria in the Lifestyle Requirements section
of this protocol.

- Subjects who are investigator 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, including their family members,
directly involved in the conduct of the study.

- Other acute or chronic medical or psychiatric condition including recent (within the
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.

NCT03092232
Pfizer
Completed
Single Dose Study to Assess the Safety, Tolerability and Pharmacokinetics(PK) of PF-06865571

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[email protected]

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