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An Open-label, Two-period, Fixed-sequence Study to Evaluate Multiple-dose Itraconazole Effect on The Single-dose PK of PF-06372865 in Healthy Subjects

Last updated on March 14, 2019

Study Location
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511 United States
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Females and Males
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. Healthy is
defined as no clinically relevant abnormalities identified by a detailed medical
history, full physical examination, including blood pressure and pulse rate
measurement, 12-lead ECG or clinical laboratory tests

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)

- Evidence of a personally signed and dated informed consent document indicating that
the subject has been informed of all pertinent aspects of the study

- Subjects who are willing and able to comply with all scheduled visits, treatment plan,
laboratory tests, and other study procedures

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 time of dosing)

- Hypersensitivity or previous adverse events due to azole antifungals.

- A positive urine drug screen.

- History of regular alcohol consumption exceeding 7 drinks/week for females or 14
drinks/week for males (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 of Screening.

- Use of tobacco or nicotine containing products in the past 6 months, as evident by a
positive urine Cotinine test at 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 blood pressure 140 mm Hg (systolic) or 90 mm Hg (diastolic),
following at least 5 minutes of supine rest.

- Screening supine 12-lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec
at Screening.

- Subjects with ANY of the following abnormalities in clinical laboratory tests at
Screening AND at Day 0, as assessed by the study-specific laboratory and confirmed by
a single repeat, if deemed necessary: Aspartate aminotransferase (AST)/serum glutamic
oxaloacetic transaminase (SGOT) or alanine aminotransferase (ALT)/ serum glutamic
pyruvic transaminase (SGPT) >1x upper limit of normal (ULN); Total bilirubin >1x ULN;
subjects with a history of Gilbert's syndrome may have a direct bilirubin measured and
would be eligible for this study provided the direct bilirubin is ULN.

- Pregnant female subjects; females of childbearing potential; breastfeeding female
subjects; male subjects with partners currently pregnant; male subjects able to father
children 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 two months
after the last dose of Itraconazole

- Use of prescription or nonprescription drugs and dietary supplements within 7 days or
5 half-lives (whichever is longer) prior to the first dose of investigational product.
As an exception, acetaminophen/paracetamol may be used at doses of 1 g/day. Limited
use of non-prescription medications that are not believed to affect subject safety or
the overall results of the study may be permitted on a case-by-case basis following
approval by the sponsor. Herbal supplements and hormone replacement therapy must be
discontinued at least 28 days prior to the first dose of investigational product

- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 56 days prior to dosing

- Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol

- Other severe acute or chronic medical or psychiatric condition 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

- Subjects who are investigational 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 directly involved in the conduct of
the study

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

An Open-label, Two-period, Fixed-sequence Study to Evaluate Multiple-dose Itraconazole Effect on The Single-dose PK of PF-06372865 in Healthy Subjects


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