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Evaluate Taste and Relative Bioavailability of Two Microsphere Formulations of Crizotinib in Healthy Participants

Last updated on August 7, 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.
Healthy Volunteers
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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- Male and female participants who are overtly healthy as determined by medical
evaluation including medical history, physical examination, and laboratory tests.

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

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

- Capable of giving signed informed consent as described in Appendix 1, which includes
compliance with the requirements and restrictions listed in the informed consent
document (ICD) and in this protocol.

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

- Any condition possibly affecting drug absorption (eg, gastrectomy, gastric or
intestinal bypass surgery, cholecystectomy).

- Any condition possibly affecting the ability to taste (eg, dysgeusia, respiratory

- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C;
positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core
antibody (HBcAb), or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.

- Other acute or chronic medical or psychiatric condition including recent (within the
past year) or active suicidal ideation or behavior or laboratory test 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 participant inappropriate for entry into
this study.

- 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 crizotinib.

- Participants with history of known sensitivity to esomeprazole or substituted

- Previous administration with an investigational product within 30 days or 5 half-lives
preceding the first dose of crizotinib (whichever is longer).

- A positive urine drug test or cotinine test.

- Screening supine blood pressure (BP) ?140 mm Hg (systolic) or ?90 mm Hg (diastolic),
following at least 5 minutes of supine rest. If BP is ?140 mm Hg (systolic) or ?90 mm
Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP
values should be used to determine the participant's eligibility.

- Baseline 12-lead electrocardiogram (ECG) that demonstrates clinically relevant
abnormalities that may affect participant safety or interpretation of study results
(eg, QT interval corrected using the Fridericia's method [QTcF] >450 msec, complete
left bundle branch block [LBBB], signs of an acute or indeterminate-age myocardial
infarction, ST-T interval changes suggestive of myocardial ischemia, second- or
third-degree atrioventricular [AV] block, or serious bradyarrhythmias or
tachyarrhythmias). If QTcF exceeds 450 msec, or the QRS complex exceeds 120 msec, the
ECG should be repeated 2 more times and the average of the 3 QTcF or QRS complex
values should be used to determine the participant's eligibility. Computer-interpreted
ECGs should be overread by a physician experienced in reading ECGs before excluding

- Participants 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: Aspartate aminotransferase (AST) or ALT level ?1.5 ×
upper limit of normal (ULN); Total bilirubin (TBili) level ?1.5 × ULN; participants
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 ? ULN; Estimated
glomerular filtration rate (eGFR) calculation method).

- Male participants who are unwilling or unable to comply with the contraception
requirement listed in Section 10.4.1.

- History of alcohol abuse or binge drinking and/or any other illicit drug use or
dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5
(male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule,
alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer,

1 ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).

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

- History of sensitivity to heparin or heparin-induced thrombocytopenia.

- Participants who currently smoke.

- Unwilling or unable to comply with the criteria in the Lifestyle Considerations
section of this protocol.

- 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
Pfizer employees, including their family members, directly involved in the conduct of
the study.

Evaluate Taste and Relative Bioavailability of Two Microsphere Formulations of Crizotinib in Healthy Participants


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