Relative Bioavailability Of A Crizotinib Oral Liquid Formulation To Crizotinib Formulated Capsule
Condition: Healthy
Intervention: crizotinib
Intervention description: Each subject will receive 250 mg single oral doses of oral liquid formulation and formulated capsule of crizotinib separated by at least 14 days.
Intervention MeSH terms: Crizotinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: relative bioavailability; pharmacokinetics; crizotinib; oral liquid formulation; formulated capsule

Summary:

      This study will be an open-label, randomized, 2-period, 2-treatment, 2-sequence, cross-over
      single-dose study employing administration of two oral formulations of crizotinib (OLF and
      FC) in the fasted state to healthy adult subjects. Twenty-two (22) subjects will be enrolled
      to obtain at least 20 evaluable subjects who complete the study. Each subject will receive
      two treatments (A and B) with a washout period of at least 14 days between each treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and/or female 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
             lbs).

        Exclusion Criteria:

          -  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 the 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
             medication.

          -  12-lead ECG demonstrating QTc >450 msec 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 hormonal 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 ≤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.

          -  Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
             within 56 days prior to dosing.

          -  History of sensitivity to heparin or heparin-induced thrombocytopenia.

          -  Unwilling or unable to comply with the Lifestyle Guidelines described in this
             protocol.

          -  Subjects who are investigational site staff members or subjects who are Pfizer
             employees directly involved in the conduct of the trial.

          -  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.

          -  Subjects who currently smoke.