Relative Bioavailability Of A Crizotinib Oral Liquid Formulation To Crizotinib Formulated Capsule
NCT01297595
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- 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).
- 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.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Relative Bioavailability Of A Crizotinib Oral Liquid Formulation To Crizotinib Formulated Capsule | |||
| Official Title ICMJE | A Phase 1, Open-Label, Single Dose, Randomized, Cross-Over Relative Bioavailability Study Comparing An Oral Liquid Formulation To A Formulated Capsule Of Crizotinib (PF 02341066) In Healthy Volunteers | |||
| Brief 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. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Basic Science | |||
| Condition ICMJE | Healthy | |||
| Intervention ICMJE | Drug: crizotinib
Each subject will receive 250 mg single oral doses of oral liquid formulation and formulated capsule of crizotinib separated by at least 14 days. | |||
| Study Arms ICMJE | Experimental: crizotinib
Intervention: Drug: crizotinib | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 22 | |||
| Original Estimated Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | April 2011 | |||
| Actual Primary Completion Date | April 2011 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 55 Years (Adult) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Belgium | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01297595 | |||
| Other Study ID Numbers ICMJE | A8081019 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | February 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||