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Completed

NCT Number: NCT01549574

Drug Drug Interaction Study Of Crizotinib With Esomeprazole.

This is an open-label, randomized, cross-over, single dose study in healthy volunteers to evaluate the potential effect of esomeprazole, a proton pump inhibitor, on the pharmacokinetics of crizotinib. Each subject enrolled will receive two single oral doses of crioztinib with or without esomeprazole separated by a washout period of at least 14 days.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Brussels, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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 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.
  • 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 =< 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.
  • 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.

Treatment and study plan

Crizotinib

Drug

Each subject in Treatment A will receive a 250 mg single oral dose of crizotinib administered in a fasted state as 1x 250 mg Formulated Capsule on Day 1 and each subject in Treatment B will receive a 250 mg single oral dose of crizotinib administered in a fasted state as 1x 250 mg Formulated Capsule on Day 5

Esomeprazole

Drug

Each subject in Treatment B will receive 40 mg daily dose of esomeprazole from Day 1 to Day 5

Primary outcomes

  1. Plasma AUCinf [area under the plasma concentration-time profile from time 0 to infinite time] for crizotinib

    Time frame: 2 months

  2. Plasma Cmax [maximum observed concentration] for crizotinib

    Time frame: 2 months

Secondary outcomes

  1. Plasma AUClast [area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration] for crizotinib

    Time frame: 2 months

  2. Plasma Tmax [time for maximum observed concentration] for crizotinib

    Time frame: 2 months

  3. Plasma t1/2 [terminal half-life] for crizotinib

    Time frame: 2 months

  4. Plasma CL/F [apparent oral clearance] for crizotinib

    Time frame: 2 months

  5. Plasma Vz/F [apparent volume of distribution] for crizotinib

    Time frame: 2 months

  6. Plasma AUClast for metabolite (PF-06260182) if appropriate

    Time frame: 2 months

  7. crizotinib/metabolite AUClast ratio if appropriate

    Time frame: 2 months

  8. Plasma AUCinf for metabolite (PF-06260182) if appropriate

    Time frame: 2 months

  9. crizotinib/metabolite AUCinf ratio if appropriate

    Time frame: 2 months

  10. Plasma Cmax for metabolite (PF-06260182) if appropriate

    Time frame: 2 months

  11. crizotinib/metabolite Cmax ratio if appropriate

    Time frame: 2 months

  12. Plasma Tmax for metabolite (PF-06260182) if appropriate

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Open Label, Single Dose, Randomized, Cross-Over Study To Estimate The Effect Of Esomeprazole On The Pharmacokinetics Of Crizotinib In Healthy Volunteers

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 9, 2012
Registry last updated
Jun 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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