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Evaluation Of The Potential Effect That The Administration Of Food Or Antacid Medication May Have In The Oral Absorption Of Dacomitinib (PF-00299804)

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ClinicalTrials.gov Identifier: NCT01702506
Recruitment Status : Completed
First Posted : October 8, 2012
Last Update Posted : December 18, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE October 4, 2012
First Posted Date  ICMJE October 8, 2012
Last Update Posted Date December 18, 2013
Study Start Date  ICMJE October 2012
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2013)
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [ Time Frame: 2 weeks ]
    AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). For dacomitinib and PF-05199265
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 2 weeks ]
    For dacomitinib and PF-05199265
Original Primary Outcome Measures  ICMJE
 (submitted: October 4, 2012)
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [ Time Frame: 2 weeks ]
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 2 weeks ]
Change History Complete list of historical versions of study NCT01702506 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2013)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] [ Time Frame: 2 weeks ]
    AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t).For dacomitinib and PF-05199265
  • Area under the Concentration-Time Curve (AUC) [ Time Frame: 3 days ]
    AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. For dacomitinib and PF-05199265
  • Apparent Oral Clearance (CL/F) [ Time Frame: 2 weeks ]
    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. For dacomitinib
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 2 weeks ]
    For dacomitinib and PF-05199265
  • Apparent Volume of Distribution (Vz/F) [ Time Frame: 2 weeks ]
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. For dacomitinib
  • Plasma Decay Half-Life (t1/2) [ Time Frame: 2 weeks ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. For dacomitinib
Original Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2012)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] [ Time Frame: 2 weeks ]
  • Area under the Concentration-Time Curve (AUC) [ Time Frame: 3 days ]
  • Apparent Oral Clearance (CL/F) [ Time Frame: 2 weeks ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 2 weeks ]
  • Apparent Volume of Distribution (Vz/F) [ Time Frame: 2 weeks ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: 2 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation Of The Potential Effect That The Administration Of Food Or Antacid Medication May Have In The Oral Absorption Of Dacomitinib (PF-00299804)
Official Title  ICMJE Phase 1 Three Period Crossover Study To Evaluate The Effect Of Food And Antacids On The Pharmacokinetics, Safety & Tolerability Of PF-299,804 In Healthy Volunteers Who Have Received PF-299,804
Brief Summary Evaluation of the potential effect that the administration of food or antacid medication may have in the oral absorption of dacomitinib relative to the administration of dacomitinib in absence of food or antacid medication
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 Volunteers
Intervention  ICMJE
  • Drug: dacomitinib fasted
    Overnight fasted subjects will receive a single 45 mg dose of dacomitinib
  • Drug: dacomitinib fed
    Subjects will receive a single 45 mg dose of dacomitinib with a high calorie high fat meal
  • Drug: dacomitinib+antacid
    Subjects will receive a single 45 mg dose of dacomitinib when there are treated with rabeprazole
Study Arms  ICMJE
  • Experimental: Fasted
    Dacomitinib administered under fasted conditions
    Intervention: Drug: dacomitinib fasted
  • Experimental: Fed
    Dacomitinib administered under fed conditions
    Intervention: Drug: dacomitinib fed
  • Experimental: Antacid
    Dacomitinib administered under antacid treatment
    Intervention: Drug: dacomitinib+antacid
Publications * Ruiz-Garcia A, Masters JC, Mendes da Costa L, LaBadie RR, Liang Y, Ni G, Ellery CA, Boutros T, Goldberg Z, Bello CL. Effect of food or proton pump inhibitor treatment on the bioavailability of dacomitinib in healthy volunteers. J Clin Pharmacol. 2016 Feb;56(2):223-30. doi: 10.1002/jcph.588. Epub 2015 Oct 9.

*   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
 (submitted: October 4, 2012)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy subjects including males between the ages of 18 and 55 years. Females of non childbearing potential .
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
  • An informed consent document signed and dated by the subject.

Exclusion Criteria:

  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen.
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement) or the appropriate time based on the elimination characteristics of the study medication.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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 NCT01702506
Other Study ID Numbers  ICMJE A7471015
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
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP