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Drug Drug Interaction Study Of Crizotinib With Esomeprazole.

Last updated on March 15, 2019

Study Location
Pfizer Investigational Site
Bruxelles, , B-1070 Belgium
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 male and/or female of non childbearing potential subjects 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/m^2; and a total body weight >50 kg (110

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).

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

- A positive urine drug screen.

- History of regular alcohol consumption exceeding 14 drinks/week for females or 21
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.

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

- Screening supine blood pressure >= 140 mm Hg (systolic) or >=90 mm Hg (diastolic), on
a single measurement (confirmed by a single repeat, if necessary) following at least 5
minutes of rest.

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

- Pregnant or nursing females; females of childbearing potential, including those with
tubal ligation.

- 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 study medication. Herbal
supplements and hormone replacement therapy must be discontinued 28 days prior to the
first dose of study medication. As an exception, acetaminophen/paracetamol may be used
at doses of = 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.

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

- 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.

- A positive serology for Hepatitis B or Hepatitis C.

Drug Drug Interaction Study Of Crizotinib With Esomeprazole.


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