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An Open-Label, 2 Treatment Period,Study To Study The Drug Interaction Between Repeated Doses Of Itraconazole And Single Dose Pharmacokinetics (PK) Of PF-06648671 In Healthy Adults.

Last updated on February 17, 2019

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Study Location
Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511 United States
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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1. Healthy male and/or female subjects of non childbearing potential between the ages of
18 and 55 years at the time of screening, 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.

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

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

4. 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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1. 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).

2. Hypersensitivity or previous adverse events due to azole antifungals.

3. A positive urine drug testing.

4. History of regular alcohol consumption exceeding 7 drinks/week for females or 14
drinks/week for males within 6 months of Screening.

5. Use of tobacco or nicotine containing products in excess of the equivalent of 5
cigarettes per day.

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

7. Screening supine blood pressure >=140 mm Hg (systolic) or 90 mm Hg (diastolic),
following at least 5 minutes of supine rest. If blood pressure (BP) is >=140 mm Hg
(systolic) or 90 mm Hg (diastolic), the BP should be repeated two more times and the
average of the three BP values should be used to determine the subject's eligibility.

8. Screening supine 12 lead ECG demonstrating corrected QT (QTc) >450 msec or a QRS
interval >120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should
be repeated two more times and the average of the three QTc or QRS values should be
used to determine the subject's eligibility.

9. 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>=1.5 x 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.

10. 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, or longer based upon the compound's half life characteristics, after
the last dose of investigational product.

11. 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.

12. History of hepatitis or positive testing for human immunodeficiency virus (HIV),
hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), hepatitis B
core antibody (HBcAb) or hepatitis C antibodies (HCV). As an exception, a positive
HBsAb finding as a result of subject vaccination is permissible.

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

14. Unwilling or unable to comply with the Lifestyle Requirements described in this
protocol.

15. 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.

16. Any condition possibly affecting drug absorption.

17. Have any medical conditions, medical history, or are taking any medications that are
contraindicated in the itraconazole prescribing information.

18. 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.

NCT02883114
Pfizer
Completed
An Open-Label, 2 Treatment Period,Study To Study The Drug Interaction Between Repeated Doses Of Itraconazole And Single Dose Pharmacokinetics (PK) Of PF-06648671 In Healthy Adults.

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