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A Study To Evaluate The Effect Of Itraconazole On Pharmacokinetics Of PF-06463922 In Healthy Volunteers

Last updated on March 14, 2019

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Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070 Belgium
Contact
1-800-718-1021
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 female subjects of non childbearing 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) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

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

- Any condition possibly affecting drug absorption.

- A positive urine drug test.

- History of HIV, Hep B or Hep C.

- History of regular alcohol consumption.

- Screening supine 12 lead ECG demonstrating PR interval >180 msec, QTc >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, if deemed necessary: Use this criterion to describe any laboratory parameters
that are not acceptable for the study. Examples included below:

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level >1.0 × upper
limit of normal (ULN);

- Total bilirubin level >1.0 × 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

NCT02838264
Pfizer
Completed
A Study To Evaluate The Effect Of Itraconazole On Pharmacokinetics Of PF-06463922 In Healthy Volunteers

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[email protected]

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