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Dose Proportionality Study Of PF-00345439 Formulation Under Fed Conditions

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ClinicalTrials.gov Identifier: NCT02089295
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : April 4, 2016
Sponsor:
Information provided by (Responsible Party):
Pain Therapeutics

Tracking Information
First Submitted Date  ICMJE March 13, 2014
First Posted Date  ICMJE March 17, 2014
Last Update Posted Date April 4, 2016
Study Start Date  ICMJE April 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2014)
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [ Time Frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 ]
    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).
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02089295 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2014)
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
  • Concentration at time 24 hours (C24) [ Time Frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose Proportionality Study Of PF-00345439 Formulation Under Fed Conditions
Official Title  ICMJE An Open-label, Randomized, Single-dose, Three-way Crossover Study to Evaluate the Dose Proportionality of 5 Mg, 20 Mg and 40 Mg of PF-00345439 Formulation K Under Intermediate-fat Fed Conditions in Healthy Volunteers
Brief Summary To evaluate the dose proportionality of 5 mg, 20 mg and 40 mg of PF 00345439 formulation under fed conditions in healthy volunteers.
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: Oxycodone
    One capsule of 5 mg PF-00345439 Formulation K, single dose, under fed conditions
  • Drug: Oxycodone
    One capsule of 20 mg PF-00345439 Formulation K, single dose, under fed conditions
  • Drug: Oxycodone
    One capsule of 40 mg PF-00345439 Formulation K, single dose, under fed conditions
Study Arms  ICMJE
  • Experimental: Treatment A
    Single dose of 5 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).
    Intervention: Drug: Oxycodone
  • Experimental: Treatment B
    Single dose of 20 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).
    Intervention: Drug: Oxycodone
  • Experimental: Treatment C
    Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).
    Intervention: Drug: Oxycodone
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
 (submitted: March 13, 2014)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects between 18 and 55 years of age

Exclusion Criteria:

  • Evidence or history of clinically significant disease.
  • Positive urine drug test
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02089295
Other Study ID Numbers  ICMJE B4501035
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pain Therapeutics
Study Sponsor  ICMJE Pain Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pain Therapeutics
Verification Date March 2016

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