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A Phase 1 Absolute Bioavailability Study For Oral Crizotinib In Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01168934
First received: July 22, 2010
Last updated: October 20, 2011
Last verified: October 2011
History of Changes
Results First Received: September 12, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label
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
No text entered.

Reporting Groups
  Description
Crizotinib 50 mg IV First, Then Crizotinib 250 mg Oral Single intravenous (IV) dose of crizotinib 50 milligram (mg) in first intervention period; and single oral dose of crizotinib 250 mg immediate release tablet (IRT) in second intervention period. A washout period of at least 14 days was maintained between each period.
Crizotinib 250 mg Oral First, Then Crizotinib 50 mg IV Single oral dose of crizotinib 250 mg IRT in first intervention period; and single IV dose of crizotinib 50 mg in second intervention period. A washout period of at least 14 days was maintained between each period.

Participant Flow for 3 periods

 Period 1:   First Intervention Period
    Crizotinib 50 mg IV First, Then Crizotinib 250 mg Oral     Crizotinib 250 mg Oral First, Then Crizotinib 50 mg IV  
STARTED     7     7  
COMPLETED     7     7  
NOT COMPLETED     0     0  

Period 2:   Washout Period (at Least 14 Days)
    Crizotinib 50 mg IV First, Then Crizotinib 250 mg Oral     Crizotinib 250 mg Oral First, Then Crizotinib 50 mg IV  
STARTED     7     7  
COMPLETED     7     7  
NOT COMPLETED     0     0  

Period 3:   Second Intervention Period
    Crizotinib 50 mg IV First, Then Crizotinib 250 mg Oral     Crizotinib 250 mg Oral First, Then Crizotinib 50 mg IV  
STARTED     7     7  
COMPLETED     7     7  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Entire Study Population Includes participants randomized to receive crizotinib 50 mg IV first and crizotinib 250 mg oral first.

Baseline Measures
    Entire Study Population  
Number of Participants  
[units: participants]
 		  14  
Age  
[units: years]
Mean ± Standard Deviation 		  35.7  ± 11.5  
Gender  
[units: participants]
 		 
Female     0  
Male     14  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞][dn])   [ Time Frame: 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hours (hrs) post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B ]
  Show Outcome Measure 1

2.  Primary:   Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞])   [ Time Frame: 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B ]
  Show Outcome Measure 2

3.  Secondary:   Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)   [ Time Frame: 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B ]
  Show Outcome Measure 3

4.  Secondary:   Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast[dn])   [ Time Frame: 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B ]
  Show Outcome Measure 4

5.  Secondary:   Maximum Observed Plasma Concentration (Cmax)   [ Time Frame: 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B ]
  Show Outcome Measure 5

6.  Secondary:   Time to Reach Maximum Observed Plasma Concentration (Tmax)   [ Time Frame: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B ]
  Show Outcome Measure 6

7.  Secondary:   Plasma Decay Half Life (t1/2)   [ Time Frame: 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B ]
  Show Outcome Measure 7

8.  Secondary:   Apparent Oral Clearance (CL/F)   [ Time Frame: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B ]
  Show Outcome Measure 8

9.  Secondary:   Systemic Clearance (CL)   [ Time Frame: 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A ]
  Show Outcome Measure 9

10.  Secondary:   Apparent Volume of Distribution (Vz/F)   [ Time Frame: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B ]
  Show Outcome Measure 10

11.  Secondary:   Volume of Distribution at Steady State (Vss)   [ Time Frame: 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A ]
  Show Outcome Measure 11

12.  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, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B ]
  Show Outcome Measure 12

13.  Secondary:   Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC [0 - ∞]) for Crizotinib Metabolite (PF-06260182)   [ Time Frame: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B ]
  Show Outcome Measure 13

14.  Secondary:   Maximum Observed Plasma Concentration (Cmax) for Crizotinib Metabolite (PF-06260182)   [ Time Frame: 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B ]
  Show Outcome Measure 14

15.  Secondary:   Time to Reach Maximum Observed Plasma Concentration (Tmax) for Crizotinib Metabolite (PF-06260182)   [ Time Frame: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B ]
  Show Outcome Measure 15

16.  Secondary:   Metabolite to Parent Ratio of Area Under the Curve From Time Zero to Last Quantifiable Concentration for Crizotinib Metabolite Ratio (MRAUClast)   [ Time Frame: 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B ]
  Show Outcome Measure 16

17.  Secondary:   Metabolite to Parent Ratio Area Under the Curve From Time Zero to Extrapolated Infinite Time (MRAUC [0-∞])   [ Time Frame: 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B ]
  Show Outcome Measure 17

18.  Secondary:   Metabolite to Parent Ratio Maximum Observed Plasma Concentration (MRCmax)   [ Time Frame: 0 (pre-dose), 1, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, and 144 hrs post IV crizotinib dose in Treatment A and 0 (pre-dose), 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72, 96, and 144 hrs post oral crizotinib dose in Treatment B ]
  Show Outcome Measure 18


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
No text entered.  


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: NCT01168934     History of Changes
Other Study ID Numbers: A8081010
Study First Received: July 22, 2010
Results First Received: September 12, 2011
Last Updated: October 20, 2011
Health Authority: United States: Food and Drug Administration