A Phase 1 Absolute Bioavailability Study For Oral Crizotinib In Healthy Volunteers
Condition: Healthy
Intervention: crizotinib; crizotinib
Intervention description: Treatment A: Intravenous dose of 50 mg crizotinib will be administered as directed.; Treatment B: Oral dose of 250 mg crizotinib as 1 × 50-mg Immediate Release Tablet and 2 × 100-mg Immediate Release Tablets will be administered in the fasted state as directed.
Intervention MeSH terms: Crizotinib
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: healthy volunteers; crizotinib; absolute bioavailability; pharmacokinetics

Summary:

      This study will be an open-label, randomized, 2-period, 2-treatment, 2-sequence, cross-over
      single-dose study to test the absolute bioavailability of oral crizotinib formulation to IV
      formulation in healthy adult volunteers. Fourteen (14) subjects will be enrolled to obtain at
      least 12 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 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 and 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 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 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 at Screening.

          -  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.

          -  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 are currently smoking.