Relative Bioavailability Of A Crizotinib Oral Liquid Formulation To Crizotinib Formulated Capsule

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01297595
First received: February 15, 2011
Last updated: February 15, 2012
Last verified: February 2012
Results First Received: January 5, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Healthy
Intervention: Drug: crizotinib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Crizotinib 250 mg FC First, Then Crizotinib 250 mg OLF Single oral dose of crizotinib 250 milligram (mg) formulated capsule (FC) in first intervention period; and single oral dose of crizotinib 250 mg oral liquid formulation (OLF) in second intervention period. A washout period of at least 14 days was maintained between each crizotinib dose.
Crizotinib 250 mg OLF First, Then Crizotinib 250 mg FC Single oral dose of crizotinib 250 mg OLF in first intervention period; and single oral dose of crizotinib 250 mg FC in second intervention period. A washout period of at least 14 days was maintained between each crizotinib dose.

Participant Flow for 3 periods

Period 1:   First Intervention Period
    Crizotinib 250 mg FC First, Then Crizotinib 250 mg OLF     Crizotinib 250 mg OLF First, Then Crizotinib 250 mg FC  
STARTED     11     11  
COMPLETED     11     11  
NOT COMPLETED     0     0  

Period 2:   Washout Period (At Least 14 Days)
    Crizotinib 250 mg FC First, Then Crizotinib 250 mg OLF     Crizotinib 250 mg OLF First, Then Crizotinib 250 mg FC  
STARTED     11     11  
COMPLETED     11     11  
NOT COMPLETED     0     0  

Period 3:   Second Intervention Period
    Crizotinib 250 mg FC First, Then Crizotinib 250 mg OLF     Crizotinib 250 mg OLF First, Then Crizotinib 250 mg FC  
STARTED     11     11  
COMPLETED     11     11  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Entire Study Population Includes participants randomized to receive crizotinib 250 mg FC first and crizotinib 250 mg OLF first.

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
  22  
Age  
[units: years]
Mean ± Standard Deviation
  38.0  ± 11.9  
Gender  
[units: participants]
 
Female     0  
Male     22  



  Outcome Measures
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1.  Primary:   Area Under the Curve From Time Zero to Infinite Time [AUC (0 - ∞)]   [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hours (hrs) post crizotinib dose ]

2.  Secondary:   Time to Reach Maximum Observed Plasma Concentration (Tmax)   [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose ]

3.  Secondary:   Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)   [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose ]

4.  Secondary:   Maximum Observed Plasma Concentration (Cmax)   [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose ]

5.  Secondary:   Plasma Terminal Half-Life (t1/2)   [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose ]

6.  Secondary:   Apparent Oral Clearance (CL/F)   [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose ]

7.  Secondary:   Apparent Volume of Distribution (Vz/F)   [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose ]

8.  Secondary:   Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Crizotinib Metabolite (PF-06260182)   [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose ]

9.  Secondary:   Area Under the Curve From Time Zero to Infinite Time [AUC (0 - ∞)] for Crizotinib Metabolite (PF-06260182)   [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose ]

10.  Secondary:   Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182)   [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose ]

11.  Secondary:   Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182)   [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose ]

12.  Secondary:   Metabolite to Parent Ratio of Maximum Observed Plasma Concentration (MRCmax)   [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose ]

13.  Secondary:   Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Last Quantifiable Concentration (MRAUClast)   [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose ]

14.  Secondary:   Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Infinite Time [MRAUC (0- ∞)]   [ Time Frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96 and 144 hrs post crizotinib dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01297595     History of Changes
Other Study ID Numbers: A8081019
Study First Received: February 15, 2011
Results First Received: January 5, 2012
Last Updated: February 15, 2012
Health Authority: United States: Food and Drug Administration