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A Study to Evaluate the Effects of Food and Esomeprazole on the Pharmacokinetics of Crizotinib in a Coated Microsphere Formulation.

Last updated on March 14, 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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1. Healthy male subjects and female subjects of nonchildbearing potential between 18 and
55 years old.

2. Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

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, neurological, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at the time of dosing).

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

3. A positive urine drug test.

4. Subjects who currently smoke.

5. 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.

6. Subjects with history of known sensitivity to esomeprazole or substituted
benzimidazoles.

7. Treatment with an investigational drug within 30 days or 5 half-lives preceding the
first dose of study drug.

8. Screening supine BP greater than or equal to 140 mm Hg (systolic) or greater than or
equal to 90 mm Hg (diastolic), following at least 5 minutes of supine rest.

9. Screening supine 12-lead triplicate ECG demonstrating a corrected time from the
beginning of the Q wave to the end of the T wave corresponding to electrical systole
(QTc) interval >450 msec or a QRS complex >120 msec.

10. 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) or ALT level greater than or equal to 1.5 ×
upper limit of normal (ULN);

2. Total bilirubin (TBili) level greater than or equal to 1.5 × 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 less than or equal
to ULN.

11. Male subjects who are unwilling or unable to use 2 highly effective methods of
contraception as outlined in this protocol for the duration of the study and for at
least 90 days after the last dose of investigational product.

12. 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 IP.

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

14. 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).

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

16. 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.

17. 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 crizotinib cMS and/or
esomeprazole 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.

NCT03137134
Pfizer
Completed
A Study to Evaluate the Effects of Food and Esomeprazole on the Pharmacokinetics of Crizotinib in a Coated Microsphere Formulation.

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